Latest news with #ARCHES
Yahoo
23-05-2025
- Business
- Yahoo
Astellas Pharma and Pfizer's Xtandi shows long-term survival in prostate cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on PFE: Disclaimer & DisclosureReport an Issue Trump Trade: White House announces 'Golden Dome' missile-defense shield Class Action Lawsuit Against Cerevel Therapeutics Holdings, Inc. Pfizer's Strategic Oncology Moves: Balancing Promise and Risk Pfizer's Strategic Focus and Market Challenges Justify Hold Rating Amid Uncertainties HHS says 'taking immediate steps to implement' Trump drug pricing order
Yahoo
23-05-2025
- Business
- Yahoo
Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial
Astellas and Pfizer have reported five-year follow-up outcomes from the open-label extension of the randomised Phase III ARCHES trial. The study indicated that Xtandi (enzalutamide), combined with androgen deprivation therapy (ADT), showed a 30% decrease in the mortality risk in men with metastatic hormone-sensitive prostate cancer (mHSPC). Patients treated with the combination therapy showed a reduction against those receiving placebo plus ADT. The findings offer a longer-term perspective on the overall survival (OS) benefits of the androgen receptor pathway inhibitor (ARPI), Xtandi. Subjects with high-volume disease experienced a 36-month improvement in median OS. The study also assessed various clinically relevant subgroups, including those with low-volume disease and those previously treated with docetaxel, all demonstrating consistent survival improvements. Additionally, the occurrence of treatment-emergent adverse events in the five-year follow-up aligned with previous analyses from the ARCHES trial, without any new safety concerns identified. The placebo-controlled, multinational, double-blind trial enrolled 1,150 participants across sites in South America, Canada, Europe, the Asia-Pacific region, and the US. Its primary endpoint was radiographic progression-free survival (rPFS), with OS as a key secondary endpoint. The post hoc five-year analysis aimed to provide a comprehensive view of long-term survival benefits. Astellas' medical affairs head and executive vice-president Shontelle Dodson said: 'The survival benefits of intervention with Xtandi in advanced prostate cancer are well-recognised. 'The collective – and growing – body of data for Xtandi continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that Xtandi is changing the trajectory of those living with the disease.' Xtandi has been approved for use in more than 90 nations, including the European Union, Japan, and the US. Astellas is responsible for the global manufacturing and commercialisation outside the US while both companies jointly market the therapy within the US. Last October, Pfizer announced positive top-line data from the Phase III TALAPRO-2 study evaluating the combination of Talzenna (talazoparib) and Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC). "Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
23-05-2025
- Business
- Business Insider
Astellas Pharma and Pfizer's Xtandi shows long-term survival in prostate cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg. Confident Investing Starts Here:
Yahoo
08-04-2025
- Business
- Yahoo
California lawmakers urge Trump to spare state's hydrogen energy project
A bipartisan group of California lawmakers is calling on the Trump administration to preserve $1.2 billion in federal funds for a hydrogen energy project to help wean the state off planet-warming fossil fuels. The action follows reports in The Times and other news organizations that the administration is poised to defund nearly 300 Department of Energy projects across the country, including four of seven nascent "hydrogen hubs." Among them is ARCHES, or California's Alliance for Renewable Clean Hydrogen Energy Systems, which was awarded $1.2 billion in federal funds by the Biden administration as part of a nationwide effort to develop hydrogen energy. ARCHES also plans to bring in an additional $11.2 billion from private investors. In a letter to Energy Secretary Chris Wright dated Monday, the lawmakers said ARCHES "plays a critical role in securing American energy dominance, advancing world-leading energy technology, creating new manufacturing jobs, and lowering energy costs for American families." Read more: Trump's Department of Energy targets California and other blue states for budget cuts, according to internal documents The letter was signed by 47 of the state's 52 congressional representatives, including four Republicans: Reps. Vince Fong (R-Bakersfield), David Valadao (R-Hanford), Jay Obernolte (R-Big Bear Lake) and Young Kim (R-Anaheim Hills). Several of the hub's sites were planned for the state's right-leaning Central Valley. It was also signed by the state's two Democratic U.S. senators, Adam Schiff and Alex Padilla. The letter follows reports that ARCHES is on the Department of Energy's budget-cut list along with hundreds of other projects geared toward climate-friendly initiatives. In response to its disclosure, DOE said the agency was conducting a department-wide review and cautioned against "fake lists." The Trump administration has generally favored development of fossil fuels over clean energy. A draft of the list circulating on Capitol Hill and reviewed by The Times indicates that roughly 80% of the projects set to lose funding are in states that didn't vote for Trump in the 2024 presidential election, including the four hydrogen hubs. In addition to California, they include a Mid-Atlantic hub, a Pacific Northwest hub and Midwest hub, all of which span primarily "blue" states that tend to vote for Democrats. Three other hydrogen hubs in Republican-leaning red states and regions — Texas, Appalachia and a "heartland" hub in Minnesota, North Dakota and South Dakota — are safe, the list shows. Hydrogen is a promising source of energy that produces water vapor instead of carbon dioxide as its byproduct, which proponents say could be used to power hard-to-decarbonize industries such as steel production, manufacturing and transportation. In their letter, the lawmakers described ARCHES as a "strategic investment in American energy innovation" and noted that projects stemming from it would be dispersed across the state, including efforts to decarbonize the Ports of Long Beach, Los Angeles and Oakland by replacing diesel-powered cargo-handling equipment with hydrogen fuel cell equivalents. "The investment is already being used to bring together private industry, local governments, and community organizations to collaborate and build a secure, American-made energy future," the representatives wrote, adding that ARCHES anticipates the creation of 220,000 jobs. Read more: California will host a billion-dollar 'hydrogen hub.' What it means for our energy future The letter was spearheaded by Rep. George Whitesides (D-Agua Dulce), whose district includes Lancaster — the first city to join ARCHES when it was announced, with multiple projects planned in the area. "The bipartisan support for ARCHES shown in this letter underscores its importance to California and the nation," Whitesides wrote in a statement. "I urge the DOE to support this crucial program and preserve its funding, therefore expanding our workforce and economic opportunity." The potential cuts come as the Trump administration continues to target environmental programs in California and across the country in what officials say is an effort to ease regulatory costs, lower taxes and "unleash American energy." However, Democratic insiders said the planned cuts appear to be partisan — particularly because California's hub was the highest-scoring applicant among more than 30 projects considered for the $7 billion federal program. Its $1.2 billion award also matched that of Texas, a red state hub that was safe from the cuts. The seven hydrogen hubs were collectively expected to produce 3 million metric tons of hydrogen annually and reduce 25 million metric tons of carbon dioxide emissions, an amount roughly equivalent to that of 5.5 million gas-powered cars. "We view ARCHES as a strategic investment in American energy innovation, an all-of-the-above energy strategy, and energy independence and competitiveness," the letter says. "With that, we respectfully request that you continue supporting ARCHES and provide time for the California hub and its member organizations to further justify their vital role in meeting the energy goals of the administration." This story originally appeared in Los Angeles Times.
Los Angeles Times
08-04-2025
- Politics
- Los Angeles Times
California lawmakers urge Trump to spare state's hydrogen energy project
A bipartisan group of California lawmakers is calling on the Trump administration to preserve $1.2 billion in federal funds for a hydrogen energy project to help wean the state off planet-warming fossil fuels. The action follows reports in The Times and other news organizations that the administration is poised to defund nearly 300 Department of Energy projects across the country, including four of seven nascent 'hydrogen hubs.' Among them is ARCHES, or California's Alliance for Renewable Clean Hydrogen Energy Systems, which was awarded $1.2 billion in federal funds by the Biden administration as part of a nationwide effort to develop hydrogen energy. ARCHES also plans to bring in an additional $11.2 billion from private investors. In a letter to Energy Secretary Chris Wright dated Monday, the lawmakers said ARCHES 'plays a critical role in securing American energy dominance, advancing world-leading energy technology, creating new manufacturing jobs, and lowering energy costs for American families.' The letter was signed by 47 of the state's 52 congressional representatives, including four Republicans: Reps. Vince Fong (R-Bakersfield), David Valadao (R-Hanford), Jay Obernolte (R-Big Bear Lake) and Young Kim (R-Anaheim Hills). Several of the hub's sites were planned for the state's right-leaning Central Valley. It was also signed by the state's two Democratic U.S. senators, Adam Schiff and Alex Padilla. The letter follows reports that ARCHES is on the Department of Energy's budget-cut list along with hundreds of other projects geared toward climate-friendly initiatives. In response to its disclosure, DOE said the agency was conducting a department-wide review and cautioned against 'fake lists.' The Trump administration has generally favored development of fossil fuels over clean energy. A draft of the list circulating on Capitol Hill and reviewed by The Times indicates that roughly 80% of the projects set to lose funding are in states that didn't vote for Trump in the 2024 presidential election, including the four hydrogen hubs. In addition to California, they include a Mid-Atlantic hub, a Pacific Northwest hub and Midwest hub, all of which span primarily 'blue' states that tend to vote for Democrats. Three other hydrogen hubs in Republican-leaning red states and regions — Texas, Appalachia and a 'heartland' hub in Minnesota, North Dakota and South Dakota — are safe, the list shows. Hydrogen is a promising source of energy that produces water vapor instead of carbon dioxide as its byproduct, which proponents say could be used to power hard-to-decarbonize industries such as steel production, manufacturing and transportation. In their letter, the lawmakers described ARCHES as a 'strategic investment in American energy innovation' and noted that projects stemming from it would be dispersed across the state, including efforts to decarbonize the Ports of Long Beach, Los Angeles and Oakland by replacing diesel-powered cargo-handling equipment with hydrogen fuel cell equivalents. 'The investment is already being used to bring together private industry, local governments, and community organizations to collaborate and build a secure, American-made energy future,' the representatives wrote, adding that ARCHES anticipates the creation of 220,000 jobs. The letter was spearheaded by Rep. George Whitesides (D-Agua Dulce), whose district includes Lancaster — the first city to join ARCHES when it was announced, with multiple projects planned in the area. 'The bipartisan support for ARCHES shown in this letter underscores its importance to California and the nation,' Whitesides wrote in a statement. 'I urge the DOE to support this crucial program and preserve its funding, therefore expanding our workforce and economic opportunity.' The potential cuts come as the Trump administration continues to target environmental programs in California and across the country in what officials say is an effort to ease regulatory costs, lower taxes and 'unleash American energy.' However, Democratic insiders said the planned cuts appear to be partisan — particularly because California's hub was the highest-scoring applicant among more than 30 projects considered for the $7 billion federal program. Its $1.2 billion award also matched that of Texas, a red state hub that was safe from the cuts. The seven hydrogen hubs were collectively expected to produce 3 million metric tons of hydrogen annually and reduce 25 million metric tons of carbon dioxide emissions, an amount roughly equivalent to that of 5.5 million gas-powered cars. 'We view ARCHES as a strategic investment in American energy innovation, an all-of-the-above energy strategy, and energy independence and competitiveness,' the letter says. 'With that, we respectfully request that you continue supporting ARCHES and provide time for the California hub and its member organizations to further justify their vital role in meeting the energy goals of the administration.'
