Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study.

Abstract

Pembrolizumab with berahyaluronidase alfa, a human hyaluronidase variant, is for subcutaneous (SC) injection. The phase II, open-label, crossover study 3475A-F11 (ClinicalTrials.gov identifier: NCT06099782) assessed participant preference for SC or intravenous (IV) pembrolizumab. Participants with resected melanoma, resected renal cell carcinoma, or metastatic non-small cell lung cancer (PD-L1 tumor proportion score ≥50%) were randomly assigned 1:1 to pembrolizumab SC 395 mg (arm A) or pembrolizumab IV 200 mg (arm B) once every 3 weeks for three cycles before crossover to the other administration route for three cycles. The primary objective was participant preference for SC pembrolizumab as assessed by the Patient Preference Questionnaire. Secondary objectives included reasons for participant preference, participant satisfaction with administration route, participant choice of treatment (SC or IV) to continue after cycle 6, and safety and tolerability. Overall, 147 participants were randomly assigned (arm A = 71, arm B = 76). The participant preference rate for pembrolizumab SC was 65% (95% CI, 56 to 74). The most common reason for this preference was less time in clinic (64%). Altogether, 64%/25% of participants were very satisfied/satisfied with pembrolizumab SC; 54%/31% were very satisfied/satisfied with pembrolizumab IV. More participants chose to continue treatment after cycle 6 with pembrolizumab SC than pembrolizumab IV (68% <i>v</i> 32%). Grade 3-4 treatment-related adverse events (AEs) in cycles 1-3 occurred in one (1%; arm A) and five (7%; arm B) participants. Injection-site AEs during SC administration cycles of the crossover period occurred in nine (13%; arm A) and 11 (16%; arm B) participants (mostly grade 1). More participants preferred pembrolizumab SC over pembrolizumab IV and chose to continue with pembrolizumab SC. The results of this study suggest that pembrolizumab SC improves convenience compared with pembrolizumab IV in cancer treatment.