FDA Approves Merck’s KEYTRUDA QLEX for Solid Tumor Indications

The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administered by a healthcare provider (HCP). Merck expects to have KEYTRUDA QLEX (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. 

Approval is based on a trial comparing subcutaneous KEYTRUDA QLEX to IV KEYTRUDA administered every six weeks, each with chemotherapy that was conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. The trial demonstrated comparable pharmacokinetic exposure levels to pembrolizumab [assessed as Cycle 1 AUC0-6 weeks (area under the curve from 0 to 6 weeks) and Cycle 3 (i.e., steady state) Ctrough]. In descriptive efficacy analyses, overall response rates were similar between KEYTRUDA QLEX and KEYTRUDA (45% [95% CI: 39, 52] vs. 42% [95% CI: 33, 51]). Additionally, no notable differences were observed in progression-free survival and overall survival. Effectiveness of KEYTRUDA QLEX for its approved indications was established based on these data and pivotal trial data demonstrating comparable safety with KEYTRUDA, as well as evidence from adequate and well-controlled studies conducted with KEYTRUDA.

“This approval is significant for patients and healthcare 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 J. Thaddeus Beck, MD, FACP, 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 healthcare settings in which they can receive their therapy.”