First Patient Dosed in Trodelvy Trial for Metastatic Triple-Negative Breast Cancer

Everest Medicines announced the first patient has been dosed in China into the EVER-132-001 Phase 2b registration clinical trial evaluating Trodelvy (sacituzumab govitecan, IMMU-132) for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

EVER-132-001 is a single-arm, multi-center Phase 2b registration clinical trial that is designed to evaluate the efficacy and safety of sacituzumab govitecan in Chinese patients with mTNBC who have received at least two prior systemic chemotherapy regimens. The primary endpoint of the trial will measure objective response rate (ORR) according to RECIST v 1.1 (a validated set of criteria to assess changes in tumor burden) by an Independent Review Committee. EVER-132-001 will enroll approximately 80 mTNBC patients in China in total.

In October 2020, sacituzumab govitecan was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

“TNBC accounts for 15 to 20% of all breast cancers and is known to be the most aggressive subgroup with a high risk of recurrence. The large patient population with mTNBC in China represents a huge unmet medical need where few therapies besides the standard cytotoxic chemotherapy are available,” said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. “Clinical data generated to date suggest that sacituzumab govitecan could enable a new standard of care for patients with pre-treated mTNBC.”

“Sacituzumab govitecan is an important advancement for patients as it is the first approved antibody drug conjugate (ADC) for mTNBC worldwide and the EVER-132-001 trial is an important first step towards fulfilling our promise to patients in China with mTNBC of a potential new treatment option that can meaningfully improve their lives,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We remain committed to working tirelessly to bring this potentially transformative medicine to all mTNBC patients in China.”

Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. In September 2020 at the ESMO 2020 annual conference, Immunomedics (now part of Gilead Sciences, Inc.) presented the confirmatory Phase III trial (ASCENT) demonstrating that sacituzumab govitecan significantly improved PFS and OS over standard single agent chemotherapy in pre-treated mTNBC patients with hazard ratio of 0.41 and 0.48, respectively. Under a licensing agreement with Immunomedics, Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.