Gilead declares topline data from Phase III trial of Trodelvy combo therapy

Gilead Sciences has reported positive topline results from the Phase III ASCENT-04/KEYNOTE-D19 trial, evaluating the combination of Trodelvy (sacituzumab govitecan-hziy) and MSD’s Keytruda (pembrolizumab) in inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC). The trial met its primary endpoint, demonstrating a progression-free survival (PFS) improvement compared to Keytruda plus chemotherapy.

The global, open-label trial enrolled 443 subjects and randomized them to receive either the combination therapy or chemotherapy plus Keytruda, with an option to switch to Trodelvy upon disease progression. The safety profile was consistent with the known profiles of the individual agents, with no new safety concerns observed.

Although overall survival (OS) data is not yet mature, early trends suggest an improvement with the combination. Gilead plans to continue monitoring OS results with further follow-up and analyses.

The findings underscore the potential of Trodelvy plus Keytruda as a new treatment for PD-L1+ mTNBC patients.

25-04-2025