Dr Beck on the FDA Approval of Subcutaneous Pembrolizumab in Solid Tumors

“The approval of the subcutaneous form of pembrolizumab gives us another option that we can use to tailor treatments to [each] patient’s individual situation.”

J. Thaddeus Beck, MD, FACP, a medical oncologist at Highlands Oncology Group, discussed the clinical significance of theFDA approval of subcutaneous pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for use across all adult and pediatric (aged ≥12 years) solid tumor indications already authorized for intravenous (IV) pembrolizumab.

The regulatory decision was supported by findings from the open-label, phase 3 3475A-D77 study (NCT05722015). Subcutaneous pembrolizumab given with chemotherapy showed noninferior pharmacokinetics vs IV pembrolizumab plus chemotherapy in patients with metastatic non–small cell lung cancer, meeting predefined acceptance margins for cycle 1 AUC0-6 weeks and cycle 3 (steady-state) trough concentration.

Efficacy and safety were comparable between arms. The subcutaneous regimen induced an objective response rate of 45% (95% CI, 39%-52%) vs 42% (95% CI, 33%-51%) with the IV formulation. No meaningful differences in progression-free survival or overall survival were noted between the formulations, and no new safety signals were observed.

Beck emphasized the practical advantages of the subcutaneous formulation, stating that the subcutaneous injection is administered in minutes rather than over half an hour, thus reducing chair time. He added that in the study’s sequential-exposure design, where patients experienced both administration routes before choosing a preferred approach, the clear majority opted to continue subcutaneous dosing, citing shorter visits and lower treatment burden.

From a clinical standpoint, Beck added that subcutaneous pembrolizumab enables treatment individualization without compromising pharmacokinetic exposure, antitumor activity, or tolerability. The option may improve patient throughput in high-volume clinics, streamline care for those with transportation or scheduling constraints, and maintain continuity of immune checkpoint therapy across the same disease settings as IV pembrolizumab.

Beck concluded that the availability of a subcutaneous formulation broadens delivery choices and preserves the clinical profile of pembrolizumab, aligning immunotherapy with patient-centered, operationally efficient care.