China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023.
PRESERVE 2 Study Design
The PRESERVE 2 study is a global, multi-center, placebo-controlled, pivotal Phase III study. Patients will receive trilaciclib or placebo intravenously (IV) on the first and eighth days of a 21-day cycle, prior to first-line gemcitabine and carboplatin, until disease progression. The primary endpoint is to evaluate the effect of trilaciclib on overall survival (OS) compared with the placebo. Key secondary endpoints include the impact of trilaciclib on patients’ quality of life, bone marrow protection indicators, progression-free survival (PFS), and overall response rate (ORR). The study is being conducted in 112 clinical centers worldwide, including 13 in China.
Trilaciclib: Drug Profile and Development
Trilaciclib is a first-in-class CDK4/6 inhibitor originated by US biotech G1 Therapeutics Inc. and in-licensed by Simcere in August 2020. The drug obtained conditional market approval in July 2022 for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have not previously received systemic chemotherapy. Commercialization of trilaciclib is expected during the fourth quarter of this year.
Future Outlook
The completion of enrollment in the PRESERVE 2 study underscores Simcere Pharmaceutical Group’s commitment to advancing innovative treatments for metastatic triple-negative breast cancer. By evaluating the potential benefits of trilaciclib in this indication, Simcere aims to address significant unmet medical needs and improve patient outcomes.-Fineline Info & Tech
