FDA Keytruda Qlex for subcutaneous injection for adult and pediatric solid tumor indications
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
Efficacy was evaluated in Study MK-3475A-D77 (NCT05722015), a randomized, multicenter, open-label, active-controlled trial conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC), in whom there were no EGFR, ALK, or ROS1 genomic tumor aberrations. A total of 377 patients were randomized (2:1) to receive either Keytruda Qlex administered subcutaneously every six weeks with platinum doublet chemotherapy or pembrolizumab administered intravenously every six weeks with platinum doublet chemotherapy.
The primary objective was to assess the exposure of subcutaneous Keytruda Qlex compared to intravenous pembrolizumab, with dual primary pharmacokinetic (PK) endpoints of Cycle 1 AUC0-6 weeks and Cycle 3 (i.e., Steady State) Ctrough. Descriptive efficacy outcome measures were overall response rate (ORR) by blinded independent central review (BICR), progression-free survival (PFS) by BICR, and overall survival (OS). The trial met the predefined acceptance margin for the PK endpoints with the lower boundary (96% CI for Cycle 1 AUC0-6weeks and 94% CI for Cycle 3 Ctrough) of the geometric mean ratios above the pre-specified threshold of 0.8 for comparability. The confirmed ORR was 45% (95% CI: 39, 52) in the subcutaneous Keytruda Qlex arm and 42% (95% CI: 33, 51) in the intravenous pembrolizumab arm. There were no notable differences in PFS or OS observed in patients who received Keytruda Qlex compared to patients who received intravenous pembrolizumab.
