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Odronextamab monotherapy led to complete responses in all patients with previously untreated follicular lymphoma evaluable for efficacy, per initial results from the safety lead-in portion of the confirmatory Phase 3 OLYMPIA-1 trial Primary analysis from an expansion cohort of the ELM-1 trial highlighted continued efficacy and durability in diffuse large B-cell lymphoma patients whose disease had progressed after CAR-T therapy First results from the ELM-2 trial in marginal zone lymphoma demonstrated high complete response rate in patients with relapsed/refractory disease TARRYTOWN, N.Y., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab were presented at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA. The presentations, including two orals, showcase the depth and breadth of the odronextamab clinical development program, with twelve abstracts spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes across earlier lines of treatment. OLYMPIA-1 Part 1 Results Showcased Compelling Potential in Previously Untreated Follicular Lymphoma (FL) The ongoing Phase 3 OLYMPIA-1 confirmatory trial consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) evaluating odronextamab monotherapy versus rituximab plus standard-of-care chemotherapies. In Part 1 (N=13), odronextamab led to complete responses (CR) in all 12 patients evaluable for efficacy at week 12. Historical clinical trial data indicate that the standard-of-care regimen R-Chemo was associated with an objective response rate (ORR) of 89% and 67% CR rate. 1 Among the 13 patients evaluable for safety, none experienced a dose-limiting toxicity (DLT). The most common treatment-emergent adverse events (TEAEs) were cytokine release syndrome (CRS; 62%), diarrhea (46%) and rash (39%). All cases of CRS were Grade 1. Infections occurred in 39% of patients, and 15% experienced a Grade 3 infection. Grade ≥3 TEAEs occurred in 46% of patients, which included one patient who discontinued early due to elevated liver enzymes. There were no reports of tumor lysis syndrome (TLS) or immune effector cell associated neurotoxicity syndrome (ICANS). “The OLYMPIA-1 Phase 3 trial is designed to explore a novel, chemotherapy-free, fixed duration treatment that is being studied in the outpatient setting in patients with previously untreated follicular lymphoma,” said Elizabeth Brém, Associate Clinical Professor, Division of Hematology/Oncology at UC Irvine. “These compelling, initial data show the paradigm-changing potential of odronextamab in previously untreated patients and reinforce the remarkable complete response rates odronextamab demonstrated in late-line follicular lymphoma. We look forward to seeing the results of the Part 2 portion, which offers the first head-to-head evaluation of odronextamab monotherapy compared to standard-of-care chemo-immunotherapies.” Durable Responses Shown in Diffuse Large B-Cell Lymphoma (DLBCL) that has Progressed After CAR-T Therapy The primary analysis from an expansion cohort of the ELM-1 trial, which evaluated patients with DLBCL who progressed after CAR-T therapy, were presented in an oral session. Among 60 patients – with a median duration of treatment of 12 weeks (range
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Republicans Lash Out at Democrats' Claims That Trump Intelligence Pick Gabbard Is 'Compromised'ORLANDO, Fla. — UCF coach Gus Malzahn is resigning after four seasons with the school. ESPN’s Pete Thamel was the first to report the move, which will see Malzahn to leave to take the offensive coordinator job at Florida State. Malzahn previously worked with FSU coach Mike Norvell during their time at Tulsa under then-coach Todd Graham from 2007-08. The Knights ended a disappointing 4-8 season in which they lost eight of their last nine games, the longest losing streak since 2015. Malzahn, 59, was in the fourth year of a contract through 2028. His buyout, it is reported, would have been $13.75 million. He finished 27-25 at UCF but lost 16 of his last 22 games and was a dismal 4-14 in two seasons in the Big 12. After back-to-back nine-win seasons in 2021-22, the Knights went 6-7 in 2023 and 4-8 in 2024. This season started with high expectations as Malzahn made sweeping changes to the program. He retooled the strength and conditioning department and hired Ted Roof and Tim Harris Jr. as defensive and offensive coordinators, respectively. He also added nearly 50 new players to the roster, leaning heavily on the transfer market. UCF started by winning its first three games against New Hampshire, Sam Houston and a thrilling comeback at TCU, but offensive struggles saw the Knights tumble through a TBD-game losing streak to finish the season. Terry Mohajir hired Malzahn on Feb. 15, 2021, six days after he was hired to replace Danny White. The move came eight weeks after Malzahn had been fired at Auburn after eight seasons of coaching the Tigers. The two briefly worked together at Arkansas State in 2012 before Malzahn left for the Auburn job. “When he [Mohajir] offered the job, I was like, ‘I’m in.’ There wasn’t thinking about or talking about ...,” Malzahn said during his introductory press conference. “This will be one of the best programs in college football in a short time. This is a job that I plan on being here and building it.” UCF opened the 2021 season with non-conference wins over Boise State and Bethune-Cookman before traveling to Louisville on Sept. 17, where quarterback Dillon Gabriel suffered a fractured collarbone in the final minute of a 42-35 loss. Backup Mikey Keene would finish out the season as Gabriel announced his intention to transfer. The Knights would finish the season on the plus side by accepting a bid to join the Big 12 Conference in September and then by defeating Florida 29-17 in the Gasparilla Bowl. Malzahn struck transfer portal gold in the offseason when he signed former Ole Miss quarterback John Rhys Plumlee. Plumlee, a two-sport star with the Rebels, helped guide UCF to the American Athletic Conference Championship in its final season. However, Plumlee’s injury forced the Knights to go with Keene and freshman Thomas Castellanos. The team finished with losses to Tulane in the conference championship and Duke in the Military Bowl. Plumlee would return in 2023 as UCF transitioned to the Big 12 but would go down with a knee injury in the final minute of the Knights’ 18-16 win at Boise State on Sept. 9. He would miss the next four games as backup Timmy McClain took over the team. Even on his return, Plumlee couldn’t help UCF, on a five-game losing streak to open conference play. The Knights got their first Big 12 win at Cincinnati on Nov. 4 and upset No. 15 Oklahoma State the following week, but the team still needed a win over Houston in the regular-season finale to secure a bowl bid for the eighth straight season. From the moment Malzahn stepped on campus, he prioritized recruiting, particularly in Central Florida. “We’re going to recruit like our hair’s on fire,” Malzahn said at the time. “We’re going to go after the best players in America and we’re not backing down to anybody.” From 2007 to 2020, UCF signed 10 four-star high school and junior college prospects. Eight four-star prospects were in the three recruiting classes signed under Malzahn. The 2024 recruiting class earned a composite ranking of 39 from 247Sports, the highest-ranked class in school history. The 2025 recruiting class is ranked No. 41 and has commitments from three four-star prospects. Malzahn has always leaned on the transfer market, signing 60 players over the past three seasons. Some have paid huge dividends, such as Javon Baker, Lee Hunter, Kobe Hudson, Tylan Grable, Bula Schmidt, Amari Kight, Marcellus Marshall, Trent Whittemore, Gage King, Ethan Barr, Deshawn Pace and Plumlee. Others haven’t been as successful, such as quarterback KJ Jefferson, who started the first five games of this season before being benched for poor performance. Jefferson’s struggles forced the Knights to play musical chairs at quarterback, with true freshman EJ Colson, redshirt sophomore Jacurri Brown and redshirt freshman Dylan Rizk all seeing action at one point or another this season. This season’s struggles led to several players utilizing the NCAA’s redshirt rule after four games, including starting slot receiver Xavier Townsend and kicker Colton Boomer, who have also entered the transfer portal. Defensive end Kaven Call posted a letter to Malzahn on Twitter in which he accused the UCF coaching staff of recently kicking him off the team when he requested to be redshirted. 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LONDON -- Emma Hayes oversaw a dominant display from her United States team at a packed Wembley Stadium without tasting victory on her return to England on Saturday. Hayes, a Londoner who coached the U.S. women to the Olympic soccer gold medal this summer after 14 major trophies at Chelsea, came home for a friendly against European champion England. In a matchup of the two best women's teams in the FIFA rankings, the U.S. had the best chances but the game ended in a goalless draw. “I'm super proud of the way we imposed ourselves on the game, it's just the last part of the pitch,” Hayes said. “Generally, I'm pleased with the performance.” The U.S. was without its injured attacking trio of Trinity Rodman, Sophia Smith and Mallory Swanson. But the quality among the visitors still overwhelmed England, which had injury issues, too. Forward Lauren Hemp and defender Maya Le Tissier were ruled out. Alyssa Thompson's curling shot forced an early parry from England goalkeeper Mary Earps as the U.S. pinned England in its half and turned over England ball too easily in midfield. The Americans dominated possession and earned a lot of space to develop their game and press high. But they lacked an edge in the final third and could not break the deadlock. Sam Coffey's shot from the edge of the box in the 44th minute was easily stopped by Earps, and at the start of the second half U.S. captain Lindsey Horan had a goal disallowed then missed the target with an angled shot. The U.S. also received a penalty but it was reversed after the VAR showed the ball hit Alex Greenwood’s chest and not her arm. But one of the most successful coaches in the women’s game was left satisfied. Hayes won seven Women’s Super Leagues in a 12-year reign at Chelsea. During that time, the men’s team had 11 different managers. She was asked how she felt about being in the away dugout and listening to the English national anthem. “You can be two things at once,” Hayes said. “I'm a proud Englishwoman who is proud to coach America. I don't have to choose, I definitely love both countries.” ___ AP soccer: https://apnews.com/hub/soccerAfter Trump's win, Black women are rethinking their role as America's reliable political organizers
On Friday (November 22), Kendrick Lamar unveiled his new album GNX by surprise. Ever since, social media has been flooded with fans, critics, and peers' reactions to and observations about the project. In the song "wacced out murals," for example, Kendrick references Snoop Dogg supporting Drake 's infamous AI diss track "Taylor Made Freestyle." For those who don't recall, Drake replicated Snoop and 2Pac 's voices to diss Kendrick, which 2Pac's estate did not approve of . Eventually, the song was removed from DSPs after the estate threatened to take legal action against the Toronto rapper. Before that, however, Snoop posted the track on his Instagram Story, leaving Kendrick disappointed. "Snoop posted 'Taylor Made,' I prayed it was the edibles / I couldn't believe it, it was only right for me to let it go," he raps. The mention later earned a response from Snoop Dogg on X, who made it clear that he's changed his mind about backing Drizzy. Read More: Snoop Dogg's Response To Kendrick Lamar Leaves TDE Punch Laughing "K Dot new album GNX," he wrote, adding various emojis. "It was the edibles. West West King." Now, he's hopped online to show his support for Kendrick once again, this time through a video on Instagram. In the simple video, Snoop has GNX pulled up on his computer. He also captioned the clip with a series of celebratory emojis. Obviously, he's enjoying the new project, and he's not alone. Reportedly, it has already earned a whopping 120 million streams roughly 33 hours after its release. It's also garnered praise from countless other fans and peers. This includes TDE 's Top Dawg, who shared a cryptic message on his Instagram Story this weekend. "Dot is a dangerous man right now," it read. "Everything I thought he would be at 16 years old is here right now. Everybody stand down . I promise you." His post sparked some speculation among fans. For now, it remains unclear exactly what he meant. Read More: Snoop Dogg Apologizes To Kendrick Lamar For Sharing Drake's "Taylor Made Freestyle"AP News Summary at 7:43 a.m. EST
By Costas Pitas (Reuters) -President-elect Donald Trump on Monday pledged big tariffs on the United States' three largest trading partners - Canada, Mexico and China - detailing how he will implement campaign promises that could trigger trade wars. Trump, who takes office on Jan. 20, 2025, said he would impose a 25% tariff on Canada and Mexico until they clamp down on drugs, particularly fentanyl, and migrants crossing the border, in a move that would appear to violate a free-trade deal. Trump also outlined "an additional 10% tariff, above any additional tariffs" on China, in some of his most specific comments on how he will implement his economic agenda since winning the Nov. 5 election on promises to "put America first". "On January 20th, as one of my many first Executive Orders, I will sign all necessary documents to charge Mexico and Canada a 25% Tariff on ALL products coming into the United States, and its ridiculous Open Borders," he said in a post on Truth Social. While migrant arrests reached a record during President Joe Biden's presidency, straining U.S. border enforcement, illegal crossings fell dramatically this year as Biden instituted new border restrictions and Mexico stepped up enforcement. More than 83% of exports from Mexico went to the U.S. in 2023 and 75% of Canadian exports go to the country. Trump's threatened new tariff would appear to violate the terms of the U.S.-Mexico-Canada Agreement on trade. The deal which Trump signed into law took effect in 2020, and continued the largely duty-free trade between the three countries. Mexico's finance ministry said: "Mexico is the United States' top trade partner, and the USMCA provides a framework of certainty for national and international investors." The office of Canadian Prime Minister Justin Trudeau and the Canadian foreign ministry did not immediately respond to requests for comment. Canada and the United States at one point imposed sanctions on each others' products during the rancorous talks that eventually led to USMCA. The dollar rose more than 2% against the Mexican peso and jumped 1% on the Canadian dollar after Trump posted on his social media platform. Japan's Nikkei fell 1% and U.S. stock futures dropped 0.3% in the aftermath. CHINA: NO ONE WINS TRADE WARS On China, the president-elect accused Beijing of not taking strong enough action to stop the flow of illicit drugs crossing the border into the U.S. from Mexico. "Until such time as they stop, we will be charging China an additional 10% Tariff, above any additional Tariffs, on all of their many products coming into the United States of America," Trump said. A Chinese embassy spokesperson in Washington hit back. "China believes that China-U.S. economic and trade cooperation is mutually beneficial in nature. No one will win a trade war or a tariff war," Liu Pengyu said. The embassy also cited steps it said China had taken since a 2023 U.S.-China meeting after which Beijing agreed it would stem the export of items related to the production of the opioid fentanyl, a leading cause of drug overdoses in the United States. "All these prove that the idea of China knowingly allowing fentanyl precursors to flow into the United States runs completely counter to facts and reality," the spokesperson said. Trump has previously pledged to end China's most-favored-nation trading status and slap tariffs on Chinese imports in excess of 60% - much higher than those imposed during his first term. The Chinese economy is now in a much more vulnerable position given the country's prolonged property downturn, debt risks and weak domestic demand. In the run-up to the Nov. 5 election, Trump floated plans for blanket tariffs of 10% to 20% on virtually all imports. He also said he would put tariffs as high as 200% on every car coming across the U.S.-Mexico border. He also voiced his intent to formally invoke the USMCA's six-year review provision upon taking office. Currently, it is expected in July 2026. Economists say that Trump's overall tariff plans, likely his most consequential economic policy, would push U.S. import duty rates back up to 1930s-era levels, stoke inflation, collapse U.S.-China trade, draw retaliation and drastically reorder supply chains. They say tariffs are paid by the companies that import the products subject to the duties, and they either pass on the costs to consumers or accept lower profits. Trump frequently refers to countries paying as a consequence of his tariff plan, saying on Monday that Mexico and Canada will "pay a very big price." (Additional reporting by Kylie Madry, Jasper Ward, David Lawder, David Ljunggren and Brendan O'Boyle; Editing by Rami Ayyub and Stephen Coates)Canada's Trudeau returns home after Trump meeting without assurances that tariffs are off the table
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Chelsea legend’s daughter puts on busty display in little black dress days after dad ‘sent her warning’"This is a monumental moment in the history of our city," Orlando Mayor Buddy Dyer said. "We have never before had a major-league championship brought home to the city of Orlando, and you did it!"