Merck & Co., Inc. (NYSE: MRK) wonder cancer immunotherapy has managed to notch sever clinical and regulatory milestones this year.
Merck announced Monday the Phase 3 KEYNOTE-522 study that is evaluating its Keytruda in combination with chemotherapy to treat triple-negative breast cancer produced positive results. The late-stage trial met the dual primary endpoints of showing a statistically significant improvement in pathological complete response compared to chemotherapy alone, regardless of PD-L1 status, an interim analysis conducted by the Independent Data Monitoring Committee showed.
A pathological complete response is defined a a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery.
Merck also noted the safety profile of Keytruda was consistent with the previously reported studies, with no new safety issues identified.
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Separately, Merck said the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive opinion, recommending approval of Keytruda in combination with Pfizer Inc. (NYSE: PFE)'s Inlyta - a tyrokinase inhibitor – for the first-line treatment of patients with advanced renal cell carcinoma, or RCC.
"The positive opinion adopted by the EMA, which is based on data showing KEYTRUDA in combination with axitinib significantly improved overall survival regardless of PD-L1 expression, is an important step toward a new first-line treatment option for these patients," said Scot Ebbinghaus, VP, clinical research, Merck Research Labs.
Merck said it will continue the KEYNOTE-522 trial without changes to evaluate the other dual primary endpoint of event-free survival.
The company also said the CHMP recommendation for the Keytruda-Inlyta combo for RCC will be reviewed by the European Commission for marketing authorization in the European Union, with a final decision likely in the third quarter.
Merck's stock closed Friday's session at $81.43 per share. The stock has a 52-week high of $87.07 and a 52-week low of $62.38 per share.
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Photo courtesy of Merck.
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