Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC

CAR-T Digest - August 2020

24 July 2026: Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC

Gilead announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Trodelvy in combination with Keytruda as a first-line treatment for adults with PD-L1-positive (CPS ≥10) unresectable locally advanced or metastatic triple-negative breast cancer

The recommendation is supported by the phase 3 ASCENT-04/KEYNOTE-D19 trial, in which Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% versus chemotherapy plus Keytruda (PFS HR=0.65), demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
If approved by the European Commission, the combination would provide a new first-line treatment option for patients with PD-L1-positive mTNBC, an aggressive disease with historically poor outcomes, while further expanding Trodelvy’s role across the first-line metastatic TNBC treatment landscape
Trodelvy is a Trop-2-directed antibody-drug conjugate that delivers the topoisomerase I inhibitor SN-38 directly to tumor cells. In combination with the PD-1 inhibitor Keytruda, the regimen is designed to enhance anti-tumor activity through complementary cytotoxic and immune-mediated mechanisms
Strategically, the positive CHMP opinion marks another major regulatory milestone for Trodelvy in first-line mTNBC, strengthening Gilead’s position in the ADC market and supporting its strategy of establishing Trodelvy as a backbone therapy across patients regardless of PD-L1 status through the complementary ASCENT-03 and ASCENT-04 clinical programs