Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study
Published report from the trial registered as NCT06099782, in JCO Oncology Practice (2026), chosen as the most cited paper whose own text cites the registry id.
Overview
Purpose: 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.
Methods: 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.
Results: 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% v 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).
Conclusion: 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.
Indexed on Europe PMC as PubMed record 42234938 (DOI 10.1200/op-25-01248). Its abstract cites the registry id NCT06099782, which is how it was matched to this trial; no figure has been checked by an editor.
This is the paper Europe PMC returns for registry id NCT06099782 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.