- Merck (NYSE:MRK) announces positive results from the Phase 3 KEYNOTE-355 trial evaluating Keytruda, in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC).
- Findings from the final analysis show first-line treatment with Keytruda in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with chemotherapy alone in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10).
- No new safety signals were identified.
- These OS results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
- These OS results follow a previous interim analysis that showed Keytruda in combination with chemotherapy significantly improved PFS compared with chemotherapy alone.
- Earlier today, the FDA approved Keytruda/chemotherapy combo for treatment of patients with high-risk early-stage mTNBC.