FOSTER CITY, CA, USA I October 28, 2021 I Gilead 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).
Under 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.
“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.”
Metastatic 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.
The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
The 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Triple-Negative Breast Cancer (TNBC)
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Beyond the approvals of Trodelvy in the United States, it is also approved in Australia, Canada, Great Britain and Switzerland for adults with metastatic TNBC. Trodelvy is also under multiple regulatory reviews worldwide, including the EU, as well as in Singapore and China through our partner Everest Medicines. Trodelvy continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.
In the United States, Trodelvy is indicated for the treatment of:
- Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
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FOSTER CITY, CA, USA I October 28, 2021 I Gilead 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).
Under 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.
“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.”
Metastatic 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.
The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
The 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Triple-Negative Breast Cancer (TNBC)
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Beyond the approvals of Trodelvy in the United States, it is also approved in Australia, Canada, Great Britain and Switzerland for adults with metastatic TNBC. Trodelvy is also under multiple regulatory reviews worldwide, including the EU, as well as in Singapore and China through our partner Everest Medicines. Trodelvy continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.
In the United States, Trodelvy is indicated for the treatment of:
- Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
SOURCE: Gilead Sciences
Post Views: 15
