489 An early phase expansion cohort study of fianlimab (anti–lymphocyte activation gene-3 [LAG-3]) plus cemiplimab (anti–programmed cell death-1 [PD-1]) in patients with advanced malignancies

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Background Concurrent blockade of LAG-3 may enhance the efficacy of anti–PD-1 therapies. We present safety and clinical activity data from an early phase expansion cohort (EC) study in patients with advanced malignancies (non-small cell lung cancer [NSCLC], clear cell renal cell carcinoma [ccRCC], head and neck squamous cell carcinoma [HNSCC], and cutaneous squamous cell carcinoma [CSCC]) treated with fianlimab 1600 mg + cemiplimab 350 mg intravenously every 3 weeks for up to 24 months. Methods EC 1, 2, 3, 4, 11, 12, and 13 of study NCT03005782 enrolled patients with advanced NSCLC who were anti–PD-1/PD-L1-naïve (EC 1, no prior therapy for metastatic disease or with disease progression/recurrence after one platinum-containing regimen) or anti–PD-1/L1-experienced (EC 2, ≤2 prior therapies for metastatic disease); advanced/metastatic ccRCC who were anti–PD-1/PD-L1-naïve (EC 3, ≤2 prior regimens of anti-angiogenic therapy) or anti–PD-1/L1-experienced (EC 4); recurrent and/or metastatic HNSCC who were anti–PD-1/PD-L1-naïve (EC 11, no curative options) or anti–PD-1/L1-experienced (EC 12); and locally advanced/metastatic CSCC who were anti–PD-1/L1-experienced (EC 13). Anti–PD-1/PD-L1-experienced patients had the most recent dose within 3 months before screening. Results 15 patients were enrolled in each EC as of October 31, 2023 data cutoff. The proportion of males across the ECs was 73–87%. Safety and efficacy data for ECs are presented in table 1 and table 2. Median follow-up across the ECs was 9–24 months. Any-grade and Grade ≥3 treatment-emergent adverse events (table 1) occurred in 80–100% and 27–53% of patients across the ECs, respectively. The most common treatment-related adverse events were rash (33%-EC 1), fatigue (27%-EC 2), rash and infusion-related reaction (27%-EC 3), fatigue (20%-EC 4), hypothyroidism (33%-EC 11), fatigue (20%-EC 12) and pneumonitis (20% [all grades]; 7% [grade ≥3]-EC 12), and infusion-related reaction (13%-EC 13). Investigator-assessed objective response rate (table 2) was 27% (4 partial responses [PRs]-EC 1), 7% (1 PR-EC 2), 20% (3 PRs-EC 3), 7% (1 PR-EC 4), 33% (5 PRs-EC 11), 7% (1 PR-EC 12), and 20% (2 complete responses, 1 PR-EC 13). Biomarker data will be included in the presentation. Conclusions Fianlimab + cemiplimab in patients with advanced malignancies across several cohorts showed signs of clinical efficacy with an acceptable safety profile warranting further investigation. Although activity was seen in PD-1-naïve and experienced patients, fianlimab + cemiplimab demonstrated improved efficacy in PD-1-naïve patients, with the caveat of limited patient numbers. Acknowledgements Medical writing support was provided by Dhara Patel, PhD, of Regeneron Pharmaceuticals, Inc. USA. Trial Registration Clinical Trial Registration Number: NCT03005782. Consent Written informed consent was obtained from the patient for publication of this abstract.

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