Subcutaneous Keytruda Qlex™ approved for solid tumors by the FDA

Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) has been approved for adult and pediatric solid tumor indications.

The US FDA has approved Keytruda Qlex (Merck, NJ, USA) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of Keytruda (Merck). This brings the total number of indicated cancers for Keytruda Qlex to 38.

Keytruda Qlex adds berahyaluronidase alfa, a variant of human hyaluronidase, to pembrolizumab, an antibody that blocks PD-1. This enhances Keytruda Qlex’s dispersion and permeability, enabling subcutaneous administration.

The approval is based on Study MK-3475A-D77 (NCT05722015), a randomized, multicenter, open-label, active-controlled trial conducted in patients with treatment-naïve metastatic NSCLC without EGFR, ALK, or ROS1 genomic tumor aberrations. In total, 377 patients were randomized to receive either Keytruda Qlex, administered subcutaneously every 6 weeks with platinum doublet chemotherapy, or Keytruda, administered intravenously every 6weeks with platinum doublet chemotherapy.

The study reported that the overall response rate for patients on Keytruda Qlex was 3% higher than Keytruda, at 45% versus 42%. Patients receiving Keytruda Qlex also spent less time in the treatment room compared with Keytruda, with a reduction of 49.7% compared with 47.7%.