The FDA Just Approved a KEYTRUDA Combination That Could Become the Standard First-Line Treatment for Aggressive Breast Cancer

Merck & Co., Inc. (NYSE:MRK) is one of billionaire Cliff Asness’ top 10 healthcare stock picks. On June 25, Merck & Co., Inc. (NYSE:MRK) announced that the FDA approved both KEYTRUDA and KEYTRUDA QLEX each in combination with Gilead’s Trodelvy as a first-line treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 at a Combined Positive Score of 10 or higher. KEYTRUDA is the brand name for pembrolizumab, which is given intravenously, and KEYTRUDA QLEX is the brand name for a mixture of pembrolizumab and berahyaluronidase alfa-pmph, and is given as a subcutaneous injection.

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Merck said the approvals are based on the Phase 3 KEYNOTE-D19/ASCENT-04 trial. It added that because TNBC advances rapidly, a large proportion of patients never make it to a second line of therapy, meaning the first treatment choice is often the only real opportunity to meaningfully extend life. Merck noted that these are the first approvals of a PD-1 inhibitor combined with a Trop-2-directed antibody-drug conjugate in advanced TNBC. The treatment replaces a chemotherapy backbone with a targeted-plus-immune approach.

Merck & Co., Inc. (NYSE:MRK) is a pharmaceutical company. It discovers, develops, manufactures, and markets prescription medicines, vaccines, and animal health products. Its portfolio includes KEYTRUDA and Gardasil, a vaccine for human papillomavirus.

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