KEYTRUDA QLEX(Pembrolizumab and berahyaluronidase alfa-pmph)

KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) is a drug under review as a 351(a) Biologics License Application (BLA 761467) with a PDUFA Goal Date of September 23, 2025. The application was submitted and received on January 23, 2025, and is undergoing Priority Review. The final report for Postmarketing Requirements (PMR) is due in December 2025.

Efficacy data from a randomized (2:1), open-label, multiregional clinical trial involving 251 participants in the MK-3475A + chemotherapy arm and 126 participants in the pembrolizumab IV + chemotherapy arm showed a 6-month overall survival rate of 82.4% for MK-3475A + chemo and 84.1% for pembrolizumab IV + chemo. The 9-month overall survival rates were 76.8% for MK-3475A + chemo and 72.7% for pembrolizumab IV + chemo. The median response duration was 9.1 months for MK-3475A + chemo and 8.0 months for pembrolizumab IV + chemo. The geometric mean ratio for Cycle 1 AUC0-6weeks (pembrolizumab SC vs IV) was 1.14 (96% CI: 1.06, 1.22), and for Cycle 3 Ctrough (pembrolizumab SC vs IV) was 1.67 (94% CI: 1.52, 1.84).

Safety findings for pembrolizumab SC in combination with chemotherapy, based on 251 treated patients, included a 14.3% discontinuation rate due to adverse events. The incidence of serious adverse reactions was 39%, and fatal adverse reactions occurred in 10% of patients. Dosage interruptions due to adverse reactions were observed in 45% of patients, and local injection site reactions occurred in 2.4% of patients.