Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters.

Abstract

1530 Background: Subcutaneous (SC) nivolumab and hyaluronidase-nvhy (nivo + hyal) is approved for administration across most adult solid tumor indications previously treated with intravenous (IV) nivolumab (nivo) and offers substantially shorter administration time (3-5 minutes). While clinical trial data demonstrate comparable efficacy and safety, real-world evidence on early adoption, patient selection, access-to-care considerations, and safety in community oncology settings remains limited. This study provides early real-world insight into the use of SC nivo + hyal in routine clinical practice. Methods: This non-interventional, retrospective medical chart review collected routine-care data from Florida Cancer Specialists & Research Institute LLC. Adults receiving ≥ 1 dose of nivo + hyal SC or nivo IV in 2025 were included. Follow-up extended from index (first receipt of SC or IV) through last available record, disenrollment, death, or database cutoff. Patient demographics, disease characteristics, treatment patterns, social determinants of health (SDOH; including proximity-to-care measures), and safety outcomes were summarized descriptively. Results: Ninety-eight patients were included (SC n=49; IV n=49). Baseline demographic and disease characteristics were comparable between cohorts, include age, sex, performance status, and metastatic disease prevalence. A greater proportion of SC-treated patients resided in suburban settings (45% SC, 37% IV). Mean travel distance to care was greater among SC recipients, with similar median distances and overlapping interquartile ranges; the longest observed travel distance occurred in a patient receiving SC therapy (110 miles vs 33 miles for IV). Treatment patterns were similar between groups; all patients receiving concurrent therapy were treated with oral anti-cancer agents. SC administration was primarily abdominal (90%). Among SC-treated patients, 54% initiated therapy in the first line setting, while remaining use reflected conversion from IV therapy, most commonly following nivo IV + ipilimumab induction, where SC administration is not currently indicated. No new or unexpected safety signals were observed with SC administration compared with IV nivo. Conclusions: In this early real-world community oncology analysis, nivo + hyal SC use demonstrated patient characteristics, treatment patterns, and safety comparable to nivo IV. Difference in proximity-to-care measures, including greater variability and longer travel distances among SC recipients, suggest SC administration may support treatment delivery for patients with higher geographic burden. Findings should be interpreted cautiously given the limited sample size but offer early insight into real-world adoption and access considerations for subcutaneous immunotherapy.