Japan approves Keytruda Qlex for subcutaneous use across all approved Keytruda indications

Japan approved Keytruda Qlex, the subcutaneous form of Keytruda, for every Keytruda indication already approved in Japan. The planned Japanese brand is KEYJECT, given in one minute every three weeks or two minutes every six weeks. The approval rests on the Phase 3 MK-3475A-D77 trial, where exposure matched IV Keytruda and response rates were 45% versus 42%.

• Planned Japanese brand: KEYJECT
• Dosing: one minute every 3 weeks, or two minutes every 6 weeks
• MK-3475A-D77: comparable pharmacokinetic exposure; response rate 45% subcutaneous vs 42% IV, both with chemotherapy