Nearly two-thirds of cancer patients preferred subcutaneous pembrolizumab with berahyaluronidase alfa over the standard intravenous formulation after trying both administration routes, according to a randomized phase 2 crossover study published in JCO Oncology Practice by Casarini et al. The findings highlight a shift in patient experience for individuals receiving immunotherapy across multiple solid tumor types.
Evaluating Patient Preference for Subcutaneous Immunotherapy
Between 2023 and 2024, researchers evaluated 147 adult patients with resected melanoma, resected renal cell carcinoma, and metastatic non–small cell lung cancer across global clinical sites. According to data from ClinicalTrials.gov (NCT06099782), participants were randomly assigned to receive pembrolizumab subcutaneously or intravenously for three cycles before crossing over to the alternate route for another three cycles. Among 118 evaluable patients who completed the questionnaire, the preference rate for the subcutaneous option reached 65% with a 95% confidence interval ranging from 56% to 74%.
When asked why they favored the under-the-skin injection, 64% of respondents pointed to less time spent in the clinic. Satisfaction metrics tracked closely with these preferences. Altogether, 64% of patients reported being very satisfied and 25% reported being satisfied with subcutaneous pembrolizumab. In comparison, 54% of patients felt very satisfied and 31% felt satisfied with the traditional intravenous infusion.
Pro Tip: Understanding administrative differences in oncology care helps patients discuss scheduling flexibility and chair-time reductions with their oncology care teams.
Translating Patient Preference Into Clinical Decision-Making
This stated preference directly influenced choices regarding ongoing care beyond the trial protocol. According to findings published by Casarini et al., more patients chose to continue treatment after cycle six with subcutaneous pembrolizumab than with the intravenous formulation, registering at 68% versus 32% respectively. The study authors concluded that the subcutaneous co-formulation offers a more convenient and less time-consuming route of administration without compromising efficacy and safety relative to the intravenous method.
These clinical insights build directly upon earlier pharmacokinetic findings. The phase 3 3475A-D77 trial (NCT05722015), published by Merck in March 2025, established the noninferior pharmacokinetics of subcutaneous pembrolizumab compared with intravenous Keytruda. That pivotal trial also confirmed comparable efficacy and safety when combined with platinum-doublet chemotherapy for patients with metastatic non–small cell lung cancer.
Regulatory Approvals and Operational Implications
Following the pharmacokinetic and clinical data, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection across all previously approved solid tumor indications for intravenous pembrolizumab in September 2025. This regulatory milestone sets the stage for wider adoption in oncology clinics.
Beyond patient-reported convenience, the shift toward subcutaneous administration carries operational implications for cancer centers. Reduced chair time in infusion centers allows for greater scheduling flexibility and optimized patient throughput, though those specific metrics were not directly measured in the trials.
Did You Know? Subcutaneous pembrolizumab is co-formulated with berahyaluronidase alfa.
Frequently Asked Questions
What is subcutaneous pembrolizumab?
Subcutaneous pembrolizumab is an injection form of the immunotherapy drug co-formulated with berahyaluronidase alfa, administered directly under the skin rather than through an intravenous drip.
How much time does subcutaneous administration save?
While exact infusion durations vary by clinic, 64% of patients in the phase 2 study cited less time spent in the clinic as the primary reason for favoring the subcutaneous route over intravenous delivery.
Is subcutaneous pembrolizumab as effective as the IV version?
Yes. Clinical trials including the phase 3 3475A-D77 study demonstrated noninferior pharmacokinetics, comparable efficacy, and a consistent safety profile when compared directly with intravenous pembrolizumab.
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