Merck & Co., Inc. (NYSE: MRK) has announced that the U.S. Food and Drug Administration approved two of its anti-PD-1 therapies—KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)—each to be used in combination with Padcev (enfortumab vedotin-ejfv). The regimens are indicated as neoadjuvant treatment prior to cystectomy and as continued adjuvant therapy following surgery in adults with muscle-invasive bladder cancer (MIBC).
These authorizations represent the first PD-1 inhibitor plus antibody-drug conjugate combinations approved for adult MIBC patients irrespective of cisplatin eligibility. The decision was supported by data from the Phase 3 KEYNOTE-B15 trial (EV-304), a collaboration with Pfizer and Astellas that enrolled 808 participants.
The approvals also broaden the earlier authorization derived from the Phase 3 KEYNOTE-905 trial (EV-303), which had covered the same combinations for pre- and post-surgical treatment of MIBC patients ineligible for cisplatin-based chemotherapy.
On Friday, Merck’s shares closed regular trading at $123.54, declining $1.53, or 1.22%.
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