- Gilead Sciences (GILD, Financial) reports successful Phase 3 trial results for Trodelvy® plus Keytruda® in metastatic triple-negative breast cancer.
- The combination therapy significantly improved progression-free survival in patients with PD-L1+ tumors.
- Trodelvy plus Keytruda showed a consistent safety profile, with no new safety signals observed.
Gilead Sciences, Inc. (GILD) has announced promising topline results from its Phase 3 ASCENT-04/KEYNOTE-D19 study, revealing that the combination of Trodelvy® (sacituzumab govitecan-hziy) and Keytruda® (pembrolizumab) significantly enhances progression-free survival (PFS) among patients with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC). This study enrolled 443 participants randomized to either Trodelvy plus Keytruda or standard chemotherapy plus Keytruda.
This groundbreaking trial marks the first instance of a TROP-2 antibody-drug conjugate, like Trodelvy, combined with an immunotherapy achieving superior outcomes in first-line metastatic breast cancer treatment. Although the overall survival data remains immature, early trends point towards improvement.
The combination therapy's safety profile was consistent with known profiles of each agent, with no new safety concerns identified. While Trodelvy is already approved in over 50 countries for second-line mTNBC treatment, this study's results may pave the way for its use as a first-line treatment option, pending regulatory review.
Further detailed findings from the study are expected to be shared in an upcoming medical meeting and will be discussed with regulatory authorities to explore potential expansion of Trodelvy's application in mTNBC.
