Merck & Co.’s KEYTRUDA QLEX Approved by the FDA

The U.S. Food and Drug Administration has approved Merck & Co.’s KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), a subcutaneous injection for adult patients across most solid tumor indications previously approved for KEYTRUDA (pembrolizumab). The new formulation, which combines pembrolizumab with berahyaluronidase alfa, a human hyaluronidase variant developed by Alteogen Inc., must be administered by health care providers. Merck expects KEYTRUDA QLEX to be available in the U.S. by late September.

The approval introduces a faster and more flexible administration option compared to the intravenous (IV) version of KEYTRUDA, which requires a 30-minute infusion. KEYTRUDA QLEX can be injected in one minute every three weeks or two minutes every six weeks, offering administration at various health care settings, including infusion centers, doctors’ offices, or community clinics. The injection can be given in the thigh or abdomen, avoiding a 5 cm area around the navel, potentially simplifying treatment for patients with difficult venous access.

“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers. We now have a new option with a broad set of indications that has demonstrated comparability with intravenous (IV) pembrolizumab but in a subcutaneous injection that can be administered in one minute every three weeks or two minutes every six weeks,” said Dr. J. Thaddeus Beck, oncologist and Medical Director of the Highlands’ Clinical Trials Office. “Subcutaneous pembrolizumab provides faster administration than IV pembrolizumab, offers two dosing options and gives patients more choices of health care settings in which they can receive their therapy.”

The FDA approval is supported by data from the Phase 3 Study 3475A-D77, a multicenter, randomized, open-label trial involving 377 patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 genomic tumor aberrations. Patients were randomized 2:1 to KEYTRUDA QLEX (790 mg/9,600 units) or IV pembrolizumab (400 mg) every six weeks with platinum doublet chemotherapy. Both formulations showed comparable pharmacokinetic exposure, as measured by Cycle 1 AUC and steady-state Ctrough. Overall response rates were similar (KEYTRUDA QLEX: 45% (95% CI: 39, 52); IV pembrolizumab: 42% (95% CI: 33, 51)), with no notable differences in progression-free survival (PFS) or overall survival (OS). Safety profiles were also comparable.

The approval covers 38 indications for KEYTRUDA QLEX, mirroring those of IV KEYTRUDA. Common adverse reactions in patients receiving KEYTRUDA QLEX with chemotherapy included nausea (25%), fatigue (25%), and musculoskeletal pain (21%).

Merck’s introduction of KEYTRUDA QLEX marks a step toward improving patient convenience in immunotherapy, potentially broadening access to treatment across diverse clinical settings.