As the only approved TROP2-directed antibody-drug conjugate, Trodelvy has shown survival advantages in other breast cancer indications, making it a preferred treatment according to NCCN guidelines.

Dr. Sara Tolaney, the primary investigator, emphasized the urgent need for more effective treatment options for metastatic TNBC, highlighting the promising results of the Trodelvy-Keytruda combination.

While an early trend in overall survival (OS) improvement was observed, OS data was not fully mature at the time of analysis.

Gilead is also focusing on smaller indications, such as small cell lung cancer, while exploring Trodelvy's potential in untreated non-small cell lung cancer (NSCLC).

Gilead is conducting multiple ongoing Phase 3 studies for Trodelvy across various breast cancer populations and is committed to addressing unmet medical needs in oncology.

The safety profile of the Trodelvy and Keytruda combination was consistent with known safety profiles, showing no new safety signals.

Gilead Sciences has announced promising results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which demonstrated that the combination of Trodelvy® and Keytruda® significantly improves progression-free survival (PFS) in patients with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC).

The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS compared to the combination of Keytruda with chemotherapy.

This trial is particularly notable as it is the first Phase 3 study to combine a TROP2-directed antibody-drug conjugate with a PD-1 inhibitor, potentially shifting treatment protocols for TNBC.

Currently, Trodelvy is approved in the U.S. as a third-line treatment for TNBC, and the positive ASCENT-04 results may pave the way for its use in earlier treatment lines.

Triple-negative breast cancer, which makes up about 15% of all breast cancers, has historically been difficult to treat, particularly in patients with PD-L1+ tumors who often experience poorer outcomes.

Detailed results from the study will be presented at future medical meetings and discussed with regulatory authorities, although the use of this combination remains investigational.