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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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The European Commission has approved Gilead Sciences' Veklury (remdesivir) for use in adults at high risk of severe COVID-19 who do not require supplemental oxygen. This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on Phase 3 trial data showing an 87% reduction in hospitalization or death risk compared to placebo. Veklury is expected to relieve pressure on healthcare systems by enabling earlier intervention for high-risk patients.
Kite, a Gilead Company, and Daiichi Sankyo announced an expanded collaboration for YESCARTA® in Japan, aimed at providing treatment for patients with relapsed or refractory large B-cell lymphomas. The first treatment center has been authorized, continuing an exclusive licensing agreement from January 2017. YESCARTA® has shown an impressive objective response rate of 86.7% in Japanese clinical trials, with safety profiles aligning with international studies. The partnership emphasizes commitment to patient access and innovative cancer therapies.
Gilead's Kite presents promising Phase 2 results for Yescarta in treating high-risk large B-cell lymphoma (LBCL) as a first-line therapy. In the ZUMA-12 study, 89% of evaluable patients showed a response, with 78% achieving complete response after a single infusion. At 15.9 months median follow-up, 73% maintained ongoing responses. The study highlighted a median turnaround time of 18 days for treatment delivery. Although favorable outcomes were noted, safety observations included Grade 3 cytokine release syndrome (8%) and neurologic events (23%). Yescarta remains unapproved for first-line use.
Kite, a Gilead Company (NASDAQ: GILD), announced updated two-year results from the ZUMA-5 study of Yescarta (axicabtagene ciloleucel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma. Among 86 patients with follicular lymphoma (FL), the objective response rate was 94%, with 79% achieving complete response. The estimated median progression-free survival reached 39.6 months. The study highlights Yescarta's potential impact, with ongoing reviews in the European Union. However, the treatment carries risks, including cytokine release syndrome and neurologic toxicities.
Gilead's Kite presents five-year results from the pivotal ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) for refractory large B-cell lymphoma. Notably, 42.6% of patients are alive after five years, with a remarkable 92% of those needing no further treatment, indicating a potential cure. Among those who achieved a complete response, the five-year overall survival rate is 64.4%. These findings were shared at the 63rd ASH Annual Meeting. Medical experts underscore this as a transformative breakthrough in treatment, contrasting the average six-month life expectancy for these patients.
Gilead Sciences announced results from the ZUMA-7 trial, the first Phase 3 study of CAR T-cell therapy for relapsed or refractory large B-cell lymphoma (LBCL). Yescarta showed superior two-year event-free survival (EFS) rates of 40.5% compared to 16.3% for the standard of care (SOC). The study enrolled 359 patients and demonstrated improved quality of life for those treated with Yescarta. Regulatory filings to expand Yescarta's indication are in progress, with the FDA granting Priority Review status, targeting a decision by April 1, 2022.
Gilead Sciences (GILD) presented new data from the Phase 3 ASCENT study on Trodelvy (sacituzumab govitecan) in Black patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC). The study showed a 56% reduction in the risk of disease worsening or death, with a median progression-free survival (PFS) of 5.4 months versus 2.2 months for chemotherapy. Overall survival also improved to 13.8 months compared to 8.5 months for chemotherapy. Trodelvy demonstrated a higher overall response rate of 32% compared to 6% for chemotherapy. Safety profiles were consistent with earlier findings.
Gilead Sciences has selected AWS as its preferred cloud provider to enhance its clinical trial design and data-driven decision-making capabilities. This collaboration will leverage AWS's machine learning and analytics to refine Gilead's drug pipeline while ensuring patient privacy and data security. Gilead will also implement SAP S/4HANA for its enterprise resource planning, aiming for increased operational efficiency. Additionally, over 50% of its data center footprint will be migrated to AWS, which supports IT transformation and improved disaster recovery processes.
Gilead Sciences (NASDAQ: GILD) will present new data from the Phase 3 ASCENT study of Trodelvy at the San Antonio Breast Cancer Symposium (December 7-10). The analyses focus on treatment outcomes for Black patients with metastatic triple-negative breast cancer (TNBC) and post-progression therapy outcomes. Trodelvy is indicated for patients with metastatic TNBC who have received prior systemic therapies. The study highlights Trodelvy's potential in addressing high unmet needs in cancer care.
The European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan), developed by Gilead Sciences (GILD), for treating adult patients with metastatic triple-negative breast cancer (TNBC) after two or more therapies. The approval is supported by Phase 3 ASCENT study results, showing a 49% reduction in death risk and improved overall survival (11.8 months vs. 6.9 months). This is a significant treatment option for this aggressive cancer type, which has a five-year survival rate of only 12%. Trodelvy is also approved in several other countries.
