Gilead reports ASCENT-07 study misses primary endpoint

Gilead (GILD) Sciences announced the Phase 3 ASCENT-07 study investigating Trodelvy versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival as assessed by Blinded Independent Central Review according to RECIST v1.1 criteria. Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy. The ASCENT-07 study will continue to further assess overall survival. The safety profile was consistent with prior Trodelvy breast cancer studies and no new safety signals were identified in this patient population. Trodelvy is the only globally approved Trop-2-directed antibody-drug conjugate to show meaningful overall survival advantages in two distinct types of metastatic breast cancer: pre-treated HR+/HER2-negative metastatic breast cancer and second-line and later metastatic triple-negative breast cancer. Trodelvy is recognized as a Category 1 preferred treatment for both approved indications per the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology and is the only ADC with a European Society for Medical Oncology-Magnitude of Clinical Benefit Scale rating of 5 for metastatic TNBC and a rating of 4 for HR+/HER2 negative mBC. Trodelvy also stands as the only ADC to demonstrate a statistically significant and clinically meaningful PFS improvement in the first-line metastatic TNBC setting regardless of PD-L1 status across two positive Phase 3 studies presented earlier this year. Gilead continues to build on this foundation with a robust development program exploring Trodelvy across multiple disease stages and tumor types, including the ongoing Phase 3 ASCENT-05 study in high-risk early-stage TNBC and additional Phase 3 studies evaluating its potential in lung and gynecologic cancers. The use of Trodelvy in patients as a first treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer is investigational, and its safety and efficacy have not been established in this population. The use of Trodelvy in first-line metastatic TNBC is also investigational and the safety and efficacy have not been established for that use.