Merck’s KEYTRUDA QLEX approved in Japan for subcutaneous use across all KEYTRUDA indications
- Approved for subcutaneous use for all KEYTRUDA indications in Japan; planned local trade name is KEYJECT.
- Can be administered subcutaneously in as little as one minute every three weeks (2.4 mL) or two minutes every six weeks (4.8 mL).
- Approval based on Phase 3 MK-3475A-D77 in treatment‑naïve metastatic NSCLC, randomized 377 patients 2:1 to KEYJECT or IV KEYTRUDA with chemotherapy.
- Trial showed comparable pharmacokinetic exposure and similar ORR (45% vs 42%) with no notable differences in PFS or OS between arms.
Approval
Japan's Ministry of Health, Labor and Welfare approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa‑pmph) for subcutaneous use for all indications already approved for KEYTRUDA. In Japan the product is planned to be marketed under the trade name KEYJECT.
Clinical evidence
The approval relied on the pivotal randomized Phase 3 MK-3475A-D77 trial in treatment‑naïve metastatic non‑small cell lung cancer without EGFR, ALK or ROS1 alterations. A total of 377 patients were randomized 2:1 to receive either subcutaneous KEYJECT (790 mg/9,600 units) every six weeks with platinum doublet chemotherapy (n=251) or IV KEYTRUDA (400 mg) every six weeks with chemotherapy (n=126). The primary endpoints compared pembrolizumab exposure (Cycle 1 AUC0–6 weeks and Cycle 3 Ctrough).
Key outcomes
MK-3475A-D77 demonstrated comparable pharmacokinetic exposure between KEYJECT and IV KEYTRUDA. Descriptive efficacy analyses showed overall response rates of 45% (95% CI 39–52) for KEYJECT with chemotherapy versus 42% (95% CI 33–51) for IV KEYTRUDA with chemotherapy, with no notable differences observed in progression‑free survival or overall survival.
Product and administration
KEYTRUDA QLEX is a fixed combination of pembrolizumab and berahyaluronidase alfa (the latter developed and manufactured by Alteogen) that enables subcutaneous delivery. The formulation is 165 mg pembrolizumab + 2,000 units/mL berahyaluronidase alfa and is injected into the thigh or abdomen (avoiding a 5 cm area around the navel) over one minute every three weeks (2.4 mL) or two minutes every six weeks (4.8 mL).
Regulatory context
KEYTRUDA QLEX received U.S. FDA approval in September 2025 for the same adult solid‑tumor indications as IV KEYTRUDA, and the European Commission approved subcutaneous pembrolizumab (KEYTRUDA SC) in November 2025 for all KEYTRUDA indications in the EU.
Source: Merck