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www.90 jili.com login Elon Musk’s preschool is the next step in his anti-woke education dreams

School report cards released this month by the state provide only a “snapshot” of academic performance, Muskogee School Superintendent Jarod Mendenhall said. The Oklahoma State Department of Education uses the A-F public school report cards to provide information on different aspects of school performance, according to a department media release. Schools receive letter grades on overall performance, academic achievement, improvement from previous year, chronic absenteeism and English language proficiency progress. In Muskogee Public Schools, Sadler Arts Academy received an A overall grade and the 8th and 9th Grade Academy received a C overall grade. The other schools — Muskogee High, 6th and 7th Grade Academy and Cherokee, Creek, Irving, Pershing and Tony Goetz elementaries — received D overall grades. Mendenhall and other superintendents say the report cards do not provide a full picture of school performance. “These scores provide only a single snapshot of how a particular school is performing,” he said. “Our schools are providing much more for our students such as culture, climate, activities, etc.” Mendenhall said Muskogee uses some of the state data, along with internal assessments, to guide instruction. “We provide our students with pre-, mid-, and post-year assessments where teachers can review how our students are doing throughout the school year,” he said. “Our teachers do a fantastic job of utilizing this data, but the state scores are from last spring making it difficult to use.” He said this year’s report cards were modified this year, making it hard to use the data. “Since the system is based on a bell curve, the majority of schools throughout the state of Oklahoma must score average — C grade — for the system to work,” he said. “This is why it’s difficult to utilize this particular measurement year after year.” Mendenhall said the district does pay attention to state components indicating growth in different areas. He said the state needs to put more emphasis on measuring growth over time. “We did not see the improvement we were hoping for,” he said. “However, we saw improvement at many school sites which is encouraging. Our focus is meeting our students where they are every school year and then helping them meet the standards. I am pleased with our progress as a district and I look forward to seeing our district consistently improve year after year.” Muskogee Public Schools academic growth was within three points from state average, according to the state report card. Hilldale Schools got straight C overall grades, which is not much different from last year’s report, said Hilldale Superintendent Erik Puckett said. “We had a little growth in some academic areas at all three of our sites, and that’s encouraging,” he said. “We still work on it every day. We’ve got to get better. I think our teachers try to work hard in trying to teach the child, not just the academic part, but the social part.” Puckett said he doesn’t use the school report card to show how successful a school is. “But we do try to use the individual growth of individual students — how did one child improve from the third to the fourth grade, or from eighth to high school, “ he said. “We look at the growth we hope to see at different age levels and base instruction on the weak areas a child will have within those individual results.” He said people should not compare one school with another because demographics are different, “even within a city.” Each Fort Gibson school received a B overall grade. Superintendent Scott Farmer could not be reached. In 2023, Farmer said the district uses its own goals and measurements on academic performance. “There is no way in a large school system to boil down the performance to one letter grade,” he said in 2023. According to a Department of Education media release, the state report card compiles data for 700,000 students in Oklahoma public and public charter schools. The Oklahoma legislature established the report card system to measure school performance on different indicators.

Raiders and Saints meet with prominent players nearing statistical milestones

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Colorado QB Shedeur Sanders escaped injury after he landed awkwardly following a low hit in the first half of the Buffaloes’ game vs. Kansas. Sanders got taken out at the knees by defensive end Dean Miller after he scrambled around for a long time and fired an incomplete pass toward Will Sheppard. Take a look at the hit, which was questionable at best and dirty at worst. Kansas with a big hit on Shedeur Sanders 😬 — FOX College Football (@CFBONFOX) A flag was thrown on the play, but officials quickly said that Miller’s hit was not roughing the passer and Colorado was instead flagged for having an offensive lineman down the field when Sanders threw the ball. The QB went to the sideline after the hit but immediately returned to the game and didn’t miss a play. Colorado ended up scoring on the drive after two great catches by freshman wide receiver Drelon Miller. He had a fantastic falling grab on the sideline before capping the drive with a 19-yard TD catch that cut Kansas’ lead to 20-14. After review the catch is confirmed for 👉 What a toe tap 🔥 — FOX College Football (@CFBONFOX) The Jayhawks added to the lead before halftime and took a 23-14 margin into the break. However, that nine-point lead came courtesy of three short field goals after Kansas couldn't convert three of its four red zone trips into touchdowns.

Tickets to the $1 Billion Mega Millions Draw available this Christmas Eve on Jackpot.comLas Vegas (3-12) at New Orleans (5-10) Sunday, 1 p.m. EST, Fox BetMGM NFL odds: Raiders by 1 Against the spread: Raiders 6-9; Saints 6-9 Series record: Tied 7-7-1 Last meeting: Saints beat Raiders 24-0 on Oct. 30, 2023, at New Orleans. Last week: Raiders beat Jaguars 19-14 ; Saints lost to Packers 34-0 . Raiders offense: overall (28), rush (32), pass (14), scoring (29) Raiders defense: overall (12), rush (13), pass (9), scoring (27) Saints offense: overall (19), rush (13), pass (23), scoring (22) Saints defense: overall (30), rush (30), pass (28), scoring (T17) Turnover differential: Raiders minus-17; Saints minus-1 After his 11 catches for 99 yards last week, rookie tight end Brock Bowers has a team-leading 101 catches for a team-high 1,067 yards and four TDs. As one of few healthy skill players left on New Orleans' offense, tight end Juwan Johnson has become more prominent in the game plan. The former Penn State and Oregon receiver, who was converted to a tight end during his third NFL season (2022), now ranks second on the club in catches this season with 38 and yards receiving with 402, while his three TD catches are tied for third on the team. Bowers will test New Orleans' coverage scheme. Those Saints responsible for containing Bowers could include linebackers Demario Davis and Peter Werner, as well as safeties Will Harris and Tyrann Mathieu. Raiders guard Jordan Meredith (ankle), linebacker Kana'I Mauga (calf) and guard Jackson Powers-Jordan (quadriceps/ankle) were all listed on Las Vegas' injury report this week. The Saints listed nine players on their injury report this week, including QB Derek Carr (left hand), running back Alvin Kamara (groin), center Erik McCoy (elbow) and guard Lucas Patrick (knee), who all missed practice time. Those limited at practice this week included defensive tackle Nathan Shepherd (eye), defensive end Payton Turner (ankle), receiver Marquez Valdes-Scantling (chest) and Johnson ( foot). The Raiders have won two of the past three, while the Saints have won four of the past six. The teams have met eight times previously in New Orleans, with the Saints winning four and the Raiders winning three. The clubs' first ever meeting was a 21-all tie in New Orleans in 1971 at the old Tulane Stadium. Raiders QB Aidan O'Connell completed 24 of 38 passes (63.2 percent) for 257 yards without an interception last week. He has not thrown an interception in three of his past four games. ... Bowers last week became the second rookie in NFL history (joining Odell Beckham Jr.) and the third TE ever (joining Zach Ertz and Evan Engram) with 10 or more catches in four games in a season. Bowers’ 1,067 yards receiving leads all NFL tight ends this season and he needs just 10 more yards to surpass Hall of Famer Mike Ditka (1,076 in 1961) for the most by rookie TE. ... Veteran RB Ameer Abdullah had season-high 85 scrimmage yards (47 receiving, 38 rushing) and a TD rushing last week, giving him a TD in two straight games. He needs 75 scrimmage yards for his third season with 500 (along with 2015 and 2017). ... RB Alexander Mattison had 56 scrimmage yards and a TD rushing in Week 16. He caught a TD pass in his only career game in New Orleans, when he was with Minnesota in 2022. ... DT Adam Butler has a tackle for loss in five of his past six games and at least half a sack in three of his past four. ... DE K’lavon Chaisson had a sack last week, giving him a tackle for loss in four straight games. ... S Isaiah Pola-Mao had nine tackles and the first two forced fumbles of his career last week. ... Saints rookie QB Spencer Rattler passed for 153 yards and rushed for 28 yards in Week 16, but also was intercepted and lost a fumble. He is 0-4 as an NFL starter. ... Versatile veteran RB Alvin Kamara, who hopes to return from a groin injury before this season ends, needs 7 scrimmage yards for his fourth 1,500-yard season and needs 50 yards rushing for his first 1,000-yard rushing season. ... WR Marquez Valdes-Scantling has a TD catch in three of his past four home games. TE Foster Moreau had 91 catches, 1,107 yards receiving and 12 TD catches in 61 games with the Raiders from 2019 to 2022. Moreau has 25 catches for 335 yards and four TDs this season. ... DE Cameron Jordan has a tackle for loss in each of his past two games. ... DE Carl Granderson has sack in two of his past three home games. ... DT Khalen Saunders had career-high two passes defensed and a tackle for loss last week. ... DT Bryan Bresee, a 2023 first-round draft choice out of Clemson, has a career-best 7 1/2 sacks in 2024. ... DE Chase Young has at least half a sack and a tackle for loss in three of his past four home games. ... LB Demario Davis has 114 tackles in 2024 and is one of three players (along with Eric Kendricks and Bobby Wagner) with 100 or more tackles in each of the past eight seasons. ... S Tyrann Mathieu has 99 passes defensed. He's intercepted a pass in each of his past two games against the Raiders. Bowers is a good bet to have another big game against a defense that ranks 28th in the NFL against the pass. AP NFL: https://apnews.com/hub/NFL

There’s no escaping gold in Tarkwa. It’s in the forest. It’s under your feet as you walk the streets of Ghana’s biggest mining town. It’s the economy. Exposed holes in the ground bear witness to attempts at illegally digging out some of the precious metal and a polluted river on the edge of town shows the consequences of the boom in semi-industrial scale mining. The environmental damage has triggered a wave of protest in the capital Accra demanding a ban on all small-scale mining operations in places like Tarkwa. In turn, anxious local politicians—ahead of national elections on December 7—have tried to reassure registered mines that they will be shielded from the government’s threat to crack down on illegal activities, which it calls “galamsey”. “In Accra, they want to ban you, but I’m here to tell you that I support miners,” George Mireku Duker, the deputy mining minister and a local legislator, told managers at four underground mines during site visits in October. Duker acknowledges that illegal mining is a “worry”, but he knows that a voter backlash against the New Patriotic Party government which he is part of could cost him his job on December 7. He won the seat by just 101 votes in 2020. “The small-scale mining sector employs more than 1 million Ghanaians and large-scale mines employ less than 10,000,” Duker told Bloomberg News. “You want to take their livelihood from them?” The mines visited by Duker have existed since colonial times and are now operated either privately or for community use by Ghanaians to counterbalance the foreign grip on large-scale mining in the indebted West African country. These artisanal and small-scale (ASM) mines—defined as operations on an area smaller than 25 acres—produced more than a quarter of the four million ounces of gold Ghana officially mined in 2023, estimated to be worth $10.6 billion at today’s prices, up from 10 percent in 2012. Equipped with heavy machinery and turbocharged by lax regulation, the ASM sector remains largely informal: by some estimates, as many as 70 percent of these mines—which have mushroomed in places like Tarkwa—are unregulated. The illicit gold rush is being powered by surging prices—up by more than a third this year to a record-high of $2,787 an ounce in October—and willing buyers in Dubai and beyond. The impact in Tarkwa is visible: tents at the top of slopes, with threadbare clothes hanging over wood panels hide the activities of a mine at the heart of the town while young men loiter outside Chinese machinery shops, offering their services as operators in exchange for a share of what is found in the rivers. The line between legal and illegal operators is often blurred. “A lot of people do have a license,” says Ishmael Quaicoe, head of the environmental and safety engineering department at Tarkwa’s University of Mines and Technology, “but their operations don’t conform with what the law asks them to do.” Demonstrations in September and October focused on the impact of galamsey miners. But when the Trades Union Congress threw its weight behind the campaign it raised the stakes, calling for an outright ban on all small-scale gold mining to halt activity blamed for polluting rivers—one Ghana Water Company facility said in August that 60 percent of the raw water it treated was affected by illegal mining, depressing cocoa production and destroying forests. Both main political groups—the governing NPP and the opposition National Democratic Congress—have traded accusations over the mining issue. And with elections around the corner President Nana Akufo-Addo responded to the calls for a ban by threatening to send soldiers to mining towns to crack down on galamsey operations. He has yet to follow through on that pledge, but the announcement triggered memories of a heavy-handed effort to close down illegal mining in 2017. The ban on ASM mining lasted about two years, but the move backfired on the government, with allies citing it as one of the reasons for the loss of its parliamentary majority in the 2020 elections. At least 4.5 million people—workers and dependents—rely on gold for their livelihood, according to a 2020 government estimate. So the timing of the protests has created a dilemma for the NPP which polls suggest could be headed for its worst-ever election results on December 7, according to the Accra-based Global Analytics. For all its mineral wealth, almost 20 percent of people in Tarkwa-Nsuaem municipality—Duker’s constituency—live in acute poverty, facing multiple deprivations from a lack of clean water to decent shelter, according to the Ghana Statistical Service. A shortage of educational opportunities means young people often gravitate toward the ASM sector’s low-skilled and often dangerous jobs. “They are already dying from poverty so they don’t hear you when you talk about the dangers of mercury or cyanide,” says Elorm Ama Governor-Ababio who was arrested while participating in a protest by Democracy Hub—the activist organization—in Accra. “You put them through so much trauma that when they see a literal threat to their life they see it as a beacon of hope,” adds Governor-Ababio, who denies any wrongdoing. Making the good delivery list School children in Ghana are taught that their country—known as the Gold Coast since British colonial rule—is so rich in the precious metal that the sand glistened as the first Europeans approached shore in the 15th century. In those early days, Akan traders bartered their gold dust for European alcohol, copper and even clothing. Centuries later Ghana remains Africa’s biggest producer, with major operators such as the UK-based Anglogold Ashanti Plc, Gold Fields Ltd. from South Africa, American miner Newmont Corp and China’s Chifeng Jilong Gold Mining Co. all active. At the other end of the scale are the ASM operators. Adwoa Pokuaa Boaduo, a mining engineer who wrote a doctoral thesis on the potential for artisanal and small-scale mining reform in Ghana, says a lack of compliance checks makes it relatively easy for licensed gold buyers to purchase from illegal mines, legitimizing their output. Rosemary Addico, who leads the responsible gold program at Solidaridad’s West Africa—an NGO which encourages miners to follow global best practices—believes the onus should be on the buyers to scrutinize the source: “Once international buyers insist on some requirements, the traders will be more careful about where they are sourcing gold from and how it’s mined.” For gold to be accepted by the world’s most demanding buyers, including central banks, institutional investors and luxury brands, it must come from refiners on the London Bullion Market Association’s Good Delivery List. The influential trade body doesn’t certify mines, but does make the refiners it accredits responsible for the gold in their supply chains, leaving many loath to accept anything directly from small-scale producers that could jeopardize their place on the list. There are, however, plenty of other willing buyers of Ghanaian gold with few questions asked. Nana Akwuasi Awuah, the head of the state-owned gold marketing company—and a number of market participants—say metal from the smaller illegal mines often ends up with Dubai refineries. None of these are on the LBMA’s Good Delivery List, though the emirate does have rules requiring refiners to check that gold has been sourced responsibly. Once imported, the gold can be re-refined and sold as “recycled” bullion to jewelers in India and other markets further east, and even LBMA-accredited refiners, without reference to its origin. The LBMA requires refiners to conduct checks to ensure gold is sourced responsibly, but the reality is that the provenance of recycled gold can be very difficult to determine, according to a 2022 study published on the trade association’s website. Illegal mining also carries an economic cost for Ghana, which is wrestling with more than $30 billion of external debt and secured a $3 billion bailout from the International Monetary Fund last year. If the industry was formalized, Ghana would earn more than double its revenue from gold this year, according to Martin Ayisi, the chief executive officer of Ghana’s Minerals Commission, which regulates large and small miners. At least three-quarters of the country’s artisanal and small-scale gold output isn’t captured in export figures at all, he estimates. That’s because it’s either smuggled out by land to neighboring Ivory Coast, Togo and Burkina Faso, which have a lower withholding tax on unprocessed gold, or it’s treated as a transshipment from one of these countries through Ghana, even though it was mined in Ghana all along. “There are all sorts of schemes to smuggle out the gold,” says Ayisi. “There’s one way to stop it, by further dropping the tax,” which was cut to 1.5 percent from 3 percent in 2022, driving an immediate spike in Ghana’s output. The Dubai connection In 2023, the United Arab Emirates reported that $3.2 billion of gold (52.9 metric tons net weight) was imported from Ghana. That same year, Ghana reported exporting just $1.7 billion of the metal to the UAE (27.8 metric tons net weight), according to the United Nations’ Comtrade Database. That amounts to a shortfall about $1.5 billion. Dubai—one of the seven emirates that make up the UAE—has no gold mines, and has positioned itself as a hub for the metal. The LBMA considers the UAE a high-risk jurisdiction and imposes additional checks for any gold sourced from there. But Safeya AlSafi, the UAE’s acting assistant undersecretary for commercial control and governance at the Ministry of Economy, told Bloomberg News that the shortfall could be due to incorrect information from the country of origin, adding, “I don’t know exactly if there is any actual smuggling. We have a very strict system.” At the Minerals Commission, Ayisi acknowledged challenges recording what leaves Ghana. Ghana was one of the first countries in Africa to legalize artisanal and small-scale mining, a sector which globally contributes about a fifth of the world’s gold supply, according to a World Gold Council report. Today, most officials agree that further formalization is essential to curb smuggling and reverse the environmental fallout. The country has now joined a pilot program—along with Peru, the Philippines and Tanzania— to pre-approve some small-scale mines and sell their gold directly to refiners certified by the LBMA. But the lack of financial incentives to operate responsibly gives the miners little reason to join the pilot, critics say. The LBMA is partly motivated by a desire to secure more “clean” gold for its refiners, who are effectively losing out on a fifth of the global supply because of its stringent sourcing requirements. For governments it means they can sell directly to LBMA refineries, opening up a more formal market for their gold. “Will we solve all of the evils of the world?” asks Neil Harby, the LBMA’s chief technical officer. “No, but we’ve got to start somewhere.” Back in Accra, one of just three of Ghana’s 16 regions that doesn’t produce gold, the anti-galamsey movement is gaining momentum even if the protests have died down as the election focus has shifted to the economy—with inflation above 20 percent for more than a year—and a lack of jobs, in the country of 34 million. Billboard-sized images of brown rivers and reports of birth defects, allegedly linked to galamsey, have left voters with graphic images of the damage. Yet neither of the two main parties is in a position to fully capitalize on the anti-ASM anger. Both have at different times clamped down on illegal mining but have also have financially benefitted from “illegalities in the small-scale mining sector,” according to a 2021 report by a former environment minister, Kwabena Frimpong-Boateng. In 2022 Ghana passed a law that authorized mining in forest reserves earmarked for conservation. Out of these mining licenses, at least four have been granted by the government in reserves given special status due to their rare flora and fauna, according to The Fourth Estate, an investigative project by Ghanaian journalists. The Frimpong-Boateng report, which accused politicians on both sides of having a conflict of interest, was dismissed by the presidency as lacking evidence. But it prompted a probe by Ghana’s Commission on Human Rights and Administrative Justice that is continuing. “For about two decades now, parties have been rewarding their loyalists with concessions,” says E. Gyimah-Boadi, founder of the Accra-based non-partisan research network, Afrobarometer. “They are not going to expose themselves by committing to doing anything that will tie their hands.” Richard Ahiagbah, the director of communications at the NPP rejects the claim, saying that the 2017 ban, shows the government is committed to clamping down on the ASM sector. The NDC also denies any conflict of interest during their own time in office. Samuel Gyamfi, the party’s national communications officer, described the environmental crisis as “unprecedented” and blamed the NPP for it. For Dora Kowfia, a 54-year-old former artisanal miner, it is a confusing moment. She has has previously backed the NPP, but says that this time she doesn’t know who to vote for. She now sells textile at a roadside stall outside Tarkwa, overlooking the Bonsa River, where the impact of illegal mining is visible in the brown waters. Asked if she was concerned about the pollution, Kowfia, echoing a widely held view in mining communities in Ghana, says: “Accra is saying ‘stop galamsey’. I want leaders who will either protect it or bring us new jobs.” With assistance from Verity Ratcliffe, Ekow Dontoh and Michael Ovaska/BloombergDisappointing: US denies BJP’s claims of ‘Anti-Modi deep state’

RAHWAY, N.J.--(BUSINESS WIRE)--Dec 16, 2024-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. Vibostolimab is being evaluated as an investigational fixed-dose combination with pembrolizumab (KEYTRUDA ® ) in the KeyVibe program. Favezelimab is being evaluated as an investigational fixed-dose combination with pembrolizumab in the KEYFORM program. Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC). In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival. In these studies, the safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals identified. As expected with dual checkpoint inhibitor therapy, more immune-related adverse events were observed with the fixed-dose combination than with pembrolizumab. Considering the totality of data from the Phase 3 KeyVibe studies, including the efficacy outcomes from KeyVibe-003 and KeyVibe-007, the company has decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies. Separately, Merck has decided to end the favezelimab clinical development program, and will stop enrollment in the Phase 3 KEYFORM-008 trial evaluating the fixed-dose combination of favezelimab and pembrolizumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) whose disease has progressed following prior anti-PD-1 therapy. Patients currently in this trial may continue on therapy until study completion. KEYFORM-008 is the only Phase 3 study in the KEYFORM clinical development program for which results are not available. The company has made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline. This decision is not based on any concerns about the safety of this fixed-dose combination. Merck is informing study investigators for these clinical trials and advises patients to speak to their study team and physician regarding next steps and treatment options. Data analyses for the Phase 3 trials are ongoing, and the results will be shared with the scientific community. "Following a careful analysis of the data, the decision has been made to discontinue development of these candidates to prioritize other ongoing programs. We are grateful to all the patients, caregivers and investigators for their many contributions that made these studies possible," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We continue to pursue the most promising science with a focus on agents with the greatest potential to improve outcomes for more patients with cancer." About KeyVibe-003 KeyVibe-003 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04738487 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab (MK-7684A) versus pembrolizumab monotherapy, as a first-line treatment for patients with PD-L1 positive metastatic NSCLC. The primary endpoint is overall survival (OS) in participants with PD-L1 TPS ≥50%. Secondary endpoints include OS in participants with PD-L1 TPS ≥1% and TPS 1-49%, progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), safety and quality of life. The trial enrolled 1,264 patients who were randomized (1:1) to receive: About KeyVibe-007 KeyVibe-007 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05226598 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab with chemotherapy in treatment-naïve patients with metastatic NSCLC. The primary endpoint is OS in participants with PD-L1 TPS ≥1%. Secondary endpoints include OS in all participants, PFS, ORR and DOR in TPS ≥ 1% and all participants, safety and patient reported outcomes. The trial enrolled 739 patients who were randomized (1:1) to receive: About KeyVibe-006 KeyVibe-006 is a randomized, open-label Phase 3 trial (ClincialTrials.gov, NCT05298423 ) evaluating the fixed-dose combination of vibostolimab and pembrolizumab with concurrent chemoradiotherapy followed by vibostolimab and pembrolizumab versus concurrent chemoradiotherapy followed by durvalumab in patients with stage III NSCLC. The primary endpoints are PFS and OS for all participants and for participants with TPS ≥ 1%. The secondary endpoints are ORR, DOR, safety and patient reported outcomes. The trial enrolled approximately 580 patients who were randomized (1:1) to receive: About KEYFORM-008 KEYFORM-008 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05508867 ) evaluating the fixed-dose combination of favezelimab and pembrolizumab (MK-4280A) versus physician's choice chemotherapy for the treatment of patients with PD-1 relapsed or refractory classical Hodgkin lymphoma. The primary endpoint is PFS per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR). The secondary endpoints are OS, ORR, DOR and safety. The trial enrolled 169 patients who were randomized (1:1) to receive: About vibostolimab Vibostolimab (MK-7684) is an investigational humanized anti-TIGIT antibody discovered and developed by Merck. Vibostolimab restores antitumor activity by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), thereby activating T lymphocytes that help destroy tumor cells. About favezelimab Favezelimab (MK-4280) is an investigational anti-lymphocyte activation gene-3 (LAG-3) antibody. LAG-3 is a cell surface immunomodulatory receptor expressed on various immune cells that down-regulates T cell proliferation and activation. Favezelimab aims to restore T cell effector function by preventing LAG-3 from binding to its primary ligand, major histocompatibility complex (MHC) class II molecules. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%). In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%). Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. In KEYNOTE-A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy [EBRT] followed by brachytherapy [BT]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 292 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 30% of patients; those ≥1% included urinary tract infection (2.7%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 7% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (50%), vomiting (33%), urinary tract infection (32%), fatigue (26%), hypothyroidism (20%), constipation (18%), decreased appetite and weight loss (17% each), abdominal pain and pyrexia (12% each), hyperthyroidism, dysuria, rash (11% each), and pelvic pain (10%). In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each). KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%). For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%). For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%). In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%). In KEYNOTE-394, KEYTRUDA was discontinued due to adverse reactions in 13% of 299 patients with previously treated hepatocellular carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was ascites (2.3%). The most common adverse reactions in patients receiving KEYTRUDA (≥10%) were pyrexia (18%), rash (18%), diarrhea (16%), decreased appetite (15%), pruritus (12%), upper respiratory tract infection (11%), cough (11%), and hypothyroidism (10%). In KEYNOTE-966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%). In KEYNOTE-017 and KEYNOTE-913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent. In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%). In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%). In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4). Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent. Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent. Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%). In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%). Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose. Pediatric Use In KEYNOTE-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months). Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%). Geriatric Use Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. Additional Selected KEYTRUDA Indications in the U.S. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf . View source version on businesswire.com : https://www.businesswire.com/news/home/20241216638631/en/ CONTACT: Media Contacts:Robert Josephson (203) 914-2372Sienna Choi (908) 873-4311Investor Contacts:Peter Dannenbaum (732) 594-1579Steven Graziano (732) 594-1583 KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY OTHER SCIENCE SOURCE: Merck & Co., Inc. Copyright Business Wire 2024. PUB: 12/16/2024 04:30 PM/DISC: 12/16/2024 04:28 PM http://www.businesswire.com/news/home/20241216638631/en

COLUMBUS, Ohio — Will Howard passed for two touchdowns and rushed for another, TreVeyon Henderson ran for a score, and No. 2 Ohio State beat previously undefeated No. 5 Indiana 38-15 on Saturday. All Ohio State (10-1, 7-1) has to do now is beat Michigan at home next Saturday and it will earn a return to the Big Ten championship game for the first time since 2020 and get a rematch with No. 1 Oregon. The Ducks beat Ohio State 32-31 in a wild one back on Oct. 12. The Hoosiers (10-1, 7-1) had their best chance to beat the Buckeyes for the first time since 1988 but were hurt by special teams mistakes and disrupted by an Ohio State defense that sacked quarterback Kurtis Rourke five times. Howard finished 22 for 26 for 201 yards. Emeka Egbuka had seven catches for 80 yards and a TD. NO. 25 ILLINOIS 38, RUTGERS 31: Luke Altmyer found Pat Bryant for a catch-and-run, 40-yard touchdown pass with 4 seconds left, sending Illinois to a wild road victory over Rutgers. Illinois (8-3, 5-3) was down 31-30 when it sent long kicker Ethan Moczulski out for a desperation 58-yard field goal with 14 seconds to go. Rutgers (6-5, 3-5) coach Greg Schiano then called for a timeout right before Moczulski’s attempt was wide left and about 15 yards short. After the missed field goal was waved off by the timeout, Illinois coach Bret Bielema sent his offense back on the field. Altmyer hit Bryant on an in cut on the left side at the 22, and he continued across the field and scored untouched in a game that featured three lead changes in the final 3:07. IOWA 29, MARYLAND 13: Kaleb Johnson rushed for 164 yards and a touchdown on a career-high 35 carries, and Kamari Moulton scored on a 68-yard run in the fourth quarter to help Iowa outlast Maryland in College Park. Johnson scored from 2 yards out in the second quarter for his 21st rushing touchdown of the season, and the Hawkeyes (7-4, 5-3) rebounded from their loss to UCLA in their previous game. Maryland (4-7, 1-7) needed to win its final two regular-season games to reach six wins and bowl eligibility, but the Terrapins were dominated in the first half and eventually fell behind 16-0. Drew Stevens made five field goals for Iowa, including kicks from 54 yards in the second quarter, then 50 and 49 in the third. LATE FRIDAY MICHIGAN STATE 24, PURDUE 17: Aidan Chiles threw for two scores in the first half to build a three-touchdown lead and Michigan State (5-6, 3-5) held on to beat Purdue (1-10, 0-8) at home. The Spartans are a win away from being eligible for a bowl with first-year coach Jonathan Smith and they play Rutgers at home in the final regular-season game. Get local news delivered to your inbox!

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