MSD’s Keytruda combo hits primary endpoint at Phase 3 in triple-negative breast cancer

pharmafile | July 30, 2019 | News story | Manufacturing and Production, Research and Development Cancer, MSD, breast cancer, keytruda, pharma 

MSD’s blockbuster anti-PD-L1 immunotherapy Keytruda (pembrolizumab) has impressed in newly released Phase 3 data; the company announced that, when combined with chemotherapy, the drug met one of its primary endpoints in the treatment of triple-negative breast cancer (TNBC).

Findings derived from a study of 1,174 TNBC patients and analysed by the independent Data Monitoring Committee demonstrated that Keytruda generated a “statistically significant improvement” in rates of pathological complete response (pCR) compared to chemo alone, regardless of PD-L1 status, as determined by a lack of all signs of cancer found in tissue samples taken following neoadjuvant therapy and definitive surgery.

“These findings from this innovatively designed trial with Keytruda mark the first time an anti-PD-1 therapy plus chemotherapy has demonstrated a statistically significant improvement in pathological complete response rate as a neoadjuvant, or pre-surgical, segment of treatment for triple-negative breast cancer,” said Dr Roger M Perlmutter, President at Merck Research Laboratories. “TNBC is an aggressive malignancy with a high rate of recurrence within the first five years of diagnosis. We are encouraged by these results and plan to discuss these data with health authorities and to present these findings at an upcoming medical congress.”

MSD confirmed that the ongoing trial would continue in order to analyse the drug’s second primary endpoint of event-free survival (EFS).

Matt Fellows

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