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EU approves Keytruda plus chemo for metastatic triple-negative breast cancer.- Merck Inc

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Last updated:23rd Oct 2021
Published:23rd Oct 2021
Merck Inc announced that the European Commission (EC) has approved Keytruda (pembrolizumab), in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] of at least 10) and who have not received prior chemotherapy for metastatic disease.

The approval is based on final analysis from the Phase III KEYNOTE-355 trial, in which Keytruda in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) significantly improved overall survival (OS), reducing the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093), and progression-free survival (PFS), reducing the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.50-0.88]; p=0.0018) compared to chemotherapy alone in these patients. In this trial, 38% of enrolled patients had tumors expressing PD-L1 with CPS of at least 10.

Condition: Breast Cancer Triple Neg
Type: drug

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