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Gilead Sciences, Inc. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
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Gilead Sciences announced results from the Phase 3 EVOKE-01 study, evaluating Trodelvy in metastatic non-small cell lung cancer (NSCLC). The study did not meet its primary endpoint of overall survival (OS), but showed a 16% reduction in the risk of death compared to docetaxel (median OS: 11.1 vs. 9.8 months). A subgroup analysis revealed a meaningful OS improvement of 3.5 months in patients whose tumors did not respond to anti-PD-(L)1 therapy (mOS: 11.8 vs. 8.3 months). Adverse events were lower with Trodelvy (66.6%) compared to docetaxel (75.7%). Notably, more patients treated with Trodelvy were alive at 12 months (46.6% vs. 36.7%). These findings were presented at the 2024 ASCO Annual Meeting and published in the Journal of Clinical Oncology.
Gilead Sciences (Nasdaq: GILD) announced the results of its Phase 3 TROPiCS-04 study on Trodelvy® (SG) for metastatic urothelial cancer (mUC). The study compared Trodelvy to single-agent chemotherapy in patients who had received prior treatments. The primary endpoint of overall survival (OS) was not met, though there was a numerical improvement in OS favoring Trodelvy, with trends of improvement in secondary endpoints and specific subgroups. However, a higher number of deaths due to adverse events were noted in the Trodelvy group, particularly early in treatment.
Gilead highlighted that Trodelvy has a Boxed Warning for severe neutropenia and emphasized the importance of granulocyte-colony stimulating factor (G-CSF) for preventing complications. The safety profile of Trodelvy remains consistent with prior data. Gilead will discuss the results with the FDA for continued accelerated approval of Trodelvy for mUC. More data will be presented at a forthcoming medical meeting.
Gilead Sciences has partnered with the White House on the Biden Cancer Moonshot initiative to enhance cancer prevention and early detection among U.S. workers. This initiative aims to improve cancer screening rates through personalized outreach, contributing to a broader effort to combat cancer. Gilead, a biopharmaceutical company known for developing innovative medicines, operates in over 35 countries and is headquartered in Foster City, California. This partnership aligns with Gilead's mission to transform and simplify care for those with life-threatening illnesses by increasing access to vital health screenings.
Gilead Sciences (GILD) will present new research at the EASL Congress 2024 in Milan, focusing on liver diseases like PBC, HDV, HCV, HBV, and MASH/Fibrosis. Highlights include interim results from the ASSURE study on seladelpar for PBC, a Phase 2b study on Hepcludex® for HDV, and a Phase 3 study on bulevirtide monotherapy. Gilead's data aims to support WHO's goal to eliminate viral hepatitis by 2030. The company will also launch an HCV awareness program in Italy. Key findings span safety, efficacy, and long-term impacts of treatments, underscoring Gilead's commitment to addressing unmet needs in liver disease therapeutics.
Gilead Sciences hosted its first Global Health Equity Summit on May 21, 2024, in Northampton, MA. The event brought together leaders, advocates, and changemakers to discuss strategies for improving health equity and access to care. Gilead, a biopharmaceutical company, focuses on discovering, developing, and commercializing innovative medicines for critical illnesses. The company operates in over 35 countries with its headquarters in Foster City, California.
Gilead Sciences (GILD) has announced interim results from the ASSURE study, which show that seladelpar, an investigational PPAR delta agonist, significantly improves liver disease markers and reduces itching in primary biliary cholangitis (PBC) patients. The study enrolled 174 patients, with 70% of those treated for 12 months meeting the composite endpoint, and 37% achieving ALP normalization. Seladelpar also reduced other liver injury markers. No serious adverse events were reported. This data aligns with the Phase 3 RESPONSE study, highlighting seladelpar's potential as a new therapy for PBC. The FDA has accepted a New Drug Application for seladelpar, with a decision expected in August 2024.
Kite, a Gilead Company (Nasdaq: GILD), announced 12 abstracts from its CAR T-cell therapy portfolio at the 2024 European Hematology Association Annual Congress. Key highlights include higher manufacturing success rates and improved T-cell performance for Yescarta in second-line treatments for relapsed/refractory large B-cell lymphoma (R/R LBCL). Preliminary results from the ZUMA-24 study show promising safety and efficacy for outpatient administration of Yescarta. An oral presentation highlighted Phase 1 results and Phase 3 trial design of anitocabtagene autoleucel (anito-cel) for relapsed/refractory multiple myeloma (R/R MM). Kite's progress aims to enhance patient outcomes and CAR T-cell therapy accessibility, with additional studies on cost-effectiveness, safety, and real-world outcomes.
Gilead Sciences has initiated the Native Health Navigator (NHN) program, supported by their Toward Health Equity Oncology Grant. The program aims to connect Native American cancer patients to necessary medical care at CHRISTUS St. Vincent Regional Cancer Center.
Led by Olivia Sloan, a registered nurse, and Shayna Grandbois-Herrera, the program's first navigator, the NHN program assists patients with transportation, childcare, insurance, and even groceries. This initiative aims to reduce late-stage breast cancer diagnoses by providing culturally sensitive support, ultimately improving health outcomes for Native American communities.
Arcellx and Kite, in partnership with Gilead Company, announced updates on their anitocabtagene autoleucel (anito-cel) multiple myeloma program. The global Phase 3 trial, iMMagine-3, will evaluate anito-cel in patients with relapsed and/or refractory multiple myeloma exposed to specific previous treatments. The technical transfer for manufacturing anito-cel is complete, and preliminary data from the iMMagine-1 trial is expected by year-end.
Kite, a Gilead Company, and Arcellx, Inc. announced operational updates on their anito-cel multiple myeloma program. They shared the iMMagine-3 trial design, manufacturing details, and plans to present data from the iMMagine-1 trial. Anito-cel is a BCMA CAR T cell therapy for relapsed/refractory multiple myeloma.
