Gilead Sciences Inc - GILD STOCK NEWS

Gilead Sciences and Arcus Biosciences have announced significant results from Cohort B of the ARC-9 Phase 1b/2 study. The study tested a combination regimen including etrumadenant, zimberelimab, FOLFOX chemotherapy, and bevacizumab (EZFB) in third-line metastatic colorectal cancer (mCRC) patients. The EZFB regimen reduced the risk of death by 63% and disease progression by 73% compared to regorafenib. Median overall survival was 19.7 months for EZFB versus 9.5 months for regorafenib. Additionally, the EZFB regimen had a favorable safety profile with fewer treatment-emergent adverse events leading to discontinuation compared to regorafenib. These findings were presented at the ASCO Annual Meeting and highlight the potential of this combination regimen as a treatment option for mCRC patients.

Gilead Sciences and Arcus Biosciences announced positive results from the Phase 2 EDGE-Gastric study, which evaluated the combination of domvanalimab, zimberelimab, and chemotherapy in treating upper GI cancers. Results showed a median progression-free survival (PFS) of over one year, with a 12-month PFS rate of nearly 60%. The regimen demonstrated consistent objective response rates and was well-tolerated, with no unexpected safety signals. These findings support the ongoing Phase 3 STAR-221 study, which aims to confirm these results and potentially bring the first anti-TIGIT combination therapy to market for upper GI cancers. Data will be presented at the ASCO Annual Meeting.

Gilead Sciences and Arcus Biosciences announced promising results from the Phase 2 EDGE-Gastric study evaluating domvanalimab plus zimberelimab and chemotherapy in treating upper gastrointestinal (GI) cancers. The updated data show a median progression-free survival (PFS) beyond one year, surpassing historical benchmarks for similar treatments. Nearly 60% of patients achieved 12-month PFS. The ongoing Phase 3 STAR-221 study aims to further validate these results. The combination therapy was well-tolerated with a safety profile consistent with the individual components. These outcomes support the potential for this combination to address unmet needs in upper GI cancer treatment.

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.