Gilead and Merck Partner to Develop Trodelvy + Keytruda Combination for First-Line Metastatic Triple-Negative Breast Cancer

October 28, 2021 /Bio ValleyBIOON/ -- Gilead Sciences recently announced that it has signed a# Clinical TrialsCollaboration and Supply Agreement, to evaluateTrop-2-targeted antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy, sacituzumab govitecan) combined with anti-PD-1 therapy Keytruda (Keytruda, generic name: pembrolizumab, pembrolizumab), first-line treatment for locally advanced or metastatic triple-negativeBreast cancer（TNBC）。

Under the terms of the agreement, Gilead will sponsor a global Phase 3Clinical Trial, to evaluateTrodelvy + Keytruda regimen, standard of care Keytruda + chemotherapyEfficacy and safety of first-line treatment in patients with locally advanced or metastatic TNBC.

Trodelvy is a Trop-2-directed antibody-drug conjugate (ADC) approved for two indications in the United States: (1) for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have previously received at least two prior systemic therapies, at least one of which was for metastatic disease; (2) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and a PD-1 inhibitor or PD-L1 inhibitor.

Merdad Parsey, M.D., Chief Medical Officer of Gilead Sciences, stated: “Trodelvy has been established as the preferred treatment regimen for second-line metastatic TNBC. Looking ahead, we are excited about the opportunity to advance Trodelvy as a potential treatment for first-line metastatic TNBC. This further advances our goal of replacing chemotherapy with Trodelvy to improve outcomes for cancer patients.”

Breast cancer is the most common malignancy among women worldwide, with over 2 million new cases diagnosed annually. Triple-negative breast cancer (TNBC) accounts for approximately 15% of all breast cancer cases and, compared with other subtypes, is more prevalent in women under the age of 50. TNBC is specifically characterized by the negative expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). It is a rapidly progressive disease with a poor prognosis, exhibiting a 5-year survival rate of less than 15%. Metastatic TNBC demonstrates the poorest survival outcomes among all breast cancer subtypes, underscoring an urgent need for novel therapeutic strategies to improve patient prognosis.

Trodelvy is a novel, first-in-class antibody-drug conjugate (ADC) targeting Trop-2, composed of a humanized IgG1 antibody targeting the TROP-2 antigen conjugated to SN-38, the active metabolite of the chemotherapeutic agent irinotecan (a topoisomerase I inhibitor), with a drug-to-antibody ratio as high as 7.6:1. Trop-2 is a ... in many epithelialTumora cell surface protein frequently expressed in (including TNBC), and is expressed in over 90% of TNBC cases. Trodelvy specifically binds to Trop-2 and delivers the anticancer agent SN-38 to kill cancer cells.

Trodelvy, developed by Immunomedics, Inc., features a proprietary ADC platform centered on a novel linker that does not require enzymatic cleavage for payload release, enabling release within tumor cells andTumordelivery of active drugs in the microenvironment, thereby inducing a bystander effect. In April 2019,Everest Medicines entered into an agreement with Immunomedics, securing the rights to Trodelvy in Greater China, South Korea, Mongolia, and Southeast Asian countries and regions.. In September 2020, Gilead Sciences acquired Immunomedics for $21 billion, adding Trodelvy to its portfolio.

In China, Trodelvy (sacituzumab govitecan) was included in the 2020 edition of 《Guidelines for Standardized Diagnosis and Treatment of Advanced Breast Cancer in China》 in October 2020. This guideline was formulated by the Breast Cancer Expert Committee of the National Cancer Quality Control Center, the Breast Cancer Professional Committee of the China Anti-Cancer Association, and the China Anti-Cancer AssociationTumorJointly compiled by the Professional Committee on Drug Clinical Research.In May 2021, the National Medical Products Administration (NMPA) accepted the marketing authorization application for the biologic Trodelvy and granted it priority review status..(Bioon.com)

Original Source: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