Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) - (ASCENT-04/KEYNOTE-D19)

May 19, 2026: Gilead Sciences, Inc. (NASDAQ: GILD) announced the FDA approved Trodelvy (sacituzumab govitecan-hziy), a Trop-2–directed antibody-drug conjugate, for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy is approved (1) as monotherapy for patients not candidates for PD-(L)1 inhibitor–based therapy and (2) in combination with Keytruda/Keytruda Qlex (pembrolizumab) for PD-L1–positive disease (CPS ≥10) as determined by an FDA-authorized test.

Approval is based on Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19. Trodelvy regimens reduced risk of progression or death by 38% vs chemotherapy in PD-L1–ineligible patients (ASCENT-03) and by 35% vs Keytruda + chemotherapy in PD-L1+ patients (ASCENT-04). Median duration of response was 12.2 vs 7.2 months (ASCENT-03) and 16.5 vs 9.2 months (ASCENT-04; BICR).

The release notes NCCN recommends Trodelvy with or without Keytruda as a category 1 preferred first-line option across PD-L1 status, and states global regulatory submissions based on ASCENT-03/04 are underway.