Japan Approves Merck's Subcutaneous KEYTRUDA QLEX
Merck has announced that its KEYTRUDA QLEX has been approved in Japan for subcutaneous administration across all of its approved indications. This approval marks a significant milestone for patients and healthcare providers in Japan, offering more convenience and flexibility in treatment options.
KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor available in Japan that can be administered by a healthcare provider in as little as one minute. The approval was based on results from the pivotal Phase 3 MK-3475A-D77 trial, which compared KEYJECT to KEYTRUDA, both administered every six weeks with chemotherapy, 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 between KEYJECT and KEYTRUDA. In descriptive analyses, overall response rates (ORR) were consistent between KEYJECT and KEYTRUDA, with the ORR in the KEYJECT with chemotherapy arm being 45% (95% CI, 39-52) and 42% (95% CI, 33-51) in the KEYTRUDA with chemotherapy arm.