Gilead Sciences reports positive data From Phase 3 ASCENT-04/KEYNOTE-D19 study

CAR-T Digest - August 2020

21 Apr 2025: Gilead Sciences reports positive data From Phase 3 ASCENT-04/KEYNOTE-D19 study

The Phase 3 ASCENT-04 trial showed that Trodelvy combined with Keytruda significantly improved progression-free survival compared to the standard of care (Keytruda plus chemotherapy) in patients with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC)
This is the first pivotal trial to show superiority of a TROP-2-directed antibody-drug conjugate (Trodelvy) plus immunotherapy in 1st-line mTNBC treatment, with early signs of improved overall survival
The combination’s safety profile was consistent with known effects of each drug, with no new safety concerns identified
Detailed data will be shared at a future medical meeting and with regulatory authorities; overall survival results are still maturing and under follow-up
Trodelvy continues to be explored in multiple ongoing Phase 3 trials across various breast cancer subtypes and other cancers, reinforcing its role as a key ADC in oncology