doi:10.1016/j.annonc.2022.08.012 FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. Overall survival (OS) results from the phase III TROPiCS-02 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with HR+/HER2- metastatic breast cancer (mBC). US FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. “We thank the physicians, patients, and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.” “We are pleased that Trodelvy now provide new hope for living with pretreated hormone receptor–positive, HER2-negative metastatic breast cancer, building on the transformative role that Trodelvy is already playing for with metastatic triple-negative breast cancer,” Daniel O’Day, chairman and CEO of Gilead Sciences, Inc, said. Sacituzumab govitecan was first FDA approved in April 2021 for the treatment of patients with unresectable, locally advanced or metastatic triple-negative breast cancer following 2 or more systemic therapies, with at least 1 of them being for metastatic disease. No new safety signals were identified in the study. The sacituzumab govitecan arm significantly improved ORR and time to deterioration of global health status, among other secondary end points. The primary end point in the study was PFS, and secondary end points included OS, overall response rate (ORR), clinical benefit rate, duration of response, assessment of tolerability and safety, and quality-of-life measures. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than 3 months with a quality-of-life benefit for these women is exceptional.” “This approval is significant for the breast cancer community. Rugo, MD, FASCO, professor of medicine and director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, said in a statement. Nearly all with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies,” Hope S. “Despite decades of advances, living with pretreated hormone receptor–positive, HER2-negative metastatic breast cancer need new treatment options. The difference amounts to a 34% reduction in the risk of disease progression or death in the sacituzumab govitecan cohort (HR, 0.66 95% CI, 0.53-0.83 P = .0003). The median progression-free survival (PFS) was 5.5 months in the sacituzumab govitecan arm (95% CI, 4.2-7.0), whereas PFS in the chemotherapy arm was 4 months (95% CI, 3.1-4.4). Patients treated with sacituzumab govitecan showed a median OS of 14.4 months (95% CI, 13.0-15.7), whereas patients treated with single-agent chemotherapy had a median OS of 11.2 months (95% CI, 10.1-12.7), which is a 21% decrease in the risk of death among the sacituzumab govitecan cohort (HR, 0.79 95% CI, 0.65-0.96 P = .02). All patients had hormone receptor–positive, HER2-negative metastatic breast cancer and had undergone treatment with endocrine therapy, a CDK4/6 inhibitor, and 2 to 4 lines of chemotherapy for metastatic disease. 2 A total of 543 patients were enrolled in the global, multicenter, open-label TROPiCS-02 study and were randomly assigned to receive either sacituzumab govitecan or physician’s choice of single-agent chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine.
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1 The approval is based on results from the phase 3 TROPiCS-02 trial (NCT03901339), which demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with sacituzumab govitecan compared with physician’s choice of single-agent chemotherapy. The FDA approved sacituzumab govitecan (Trodelvy) on February 3 to treat patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer following endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. FDA Approves Sacituzumab Govitecan for Pretreated HR+/HER2– Metastatic Breast Cancer
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