Metastatic triple-negative breast cancer (mTNBC) with PD-L1+ tumors
GILDGilead SciencesCatalyst overview
Research summary
This catalyst tracks a Approved update for Trodelvy + Keytruda in Metastatic triple-negative breast cancer (mTNBC) with PD-L1+ tumors . The expected timing is based on the latest available company guidance and may change.
ASCENT-04/KEYNOTE-D19 study. 4/21/25- Reported positive topline results, showing significant improvement in PFS. 5/31/25- Data presented at ASCO'25. 05/21/26:- Supplemental EMA and FDA filings for ASCENT-04 Trodelvy+Keytruda in PD-L1+ 1L mTNBC are under review. 05/19/26:- FDA approved Trodelvy for first-line unresectable or metastatic mTNBC, alone or with Keytruda. 07/23/26:- CHMP recommended EU approval for Trodelvy+Keytruda in PD-L1+ 1L mTNBC; EC decision later 2026.
Verification
Confirm timing and program details against the company announcement or filing.