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Merck : Phase 3 Trial On Metastatic Triple-Negative Breast Cancer Meets Primary Endpoint

Merck & Co., Inc. (MRK) said that a phase 3 KEYNOTE-355 trial met primary endpoint of overall survival in patients with metastatic triple-negative breast cancer or mTNBC whose tumors expressed PD-L1.

Findings from the final analysis showed first-line treatment with KEYTRUDA in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall Survival 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 Overall Survival results follow a previous interim analysis that showed KEYTRUDA in combination with chemotherapy significantly improved PFS compared with chemotherapy alone in these patients.

In the U.S., KEYTRUDA is currently approved in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 as determined by an FDA-approved test.

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