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Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into a clinical trial collaboration and supply
About this update from Gilead Sciences, Inc.
[{"type":"text","content":" FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as a first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (TNBC).\n\nUnder the terms of the agreement, Gilead will sponsor a global Phase 3 clinical trial to evaluate Trodelvy in combination with KEYTRUDA compared to standard of care KEYTRUDA in combination with chemotherapy in first-line patients with locally advanced or metastatic TNBC.\n\n“Trodelvy has already been established as a preferred treatment option in second-line metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Looking ahead, we are excited about the opportunity to advance Trodelvy as a potential treatment for first-line metastatic TNBC. This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer.”\n\nMetastatic TNBC has the worst survival rate among breast cancer subtypes, and there is an urgent need for new therapies that improve patient outcomes. Trodelvy is an antibody-drug conjugate that specifically targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could provide a novel regimen in first-line metastatic TNBC.\n\nThe Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.\n\nThe combination of Trodelvy and KEYTRUDA has not been approved by any regulatory agency in any treatment setting. The safety and efficacy of this combination is under investigation and has not been established.\n\nKEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.\n\nAbout Triple-Negative Breast Cancer (TNBC)\n\nTNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all br...