Regeneron Pharmaceuticals, Inc. announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland. Presentation highlights include first clinical results and new exploratory analyses from trials investigating LAG-3 inhibitor fianlimab and/or PD-1 inhibitor Libtayo® (cemiplimab) in non-small cell lung cancer (NSCLC), melanoma and cervical cancer. Among the research published by ESMO IO were initial results for an investigational combination of fianlimab and Libtayo in patients with unresectable stage IIIB-C or IV NSCLC.

The results are from two expansion cohorts of a Phase 1 trial – one with anti-PD-1/PD-L1-naïve patients (naïve cohort) and the other with anti-PD-1/PD-L1-experienced patients (experienced cohort). Patients received fianlimab 1600 milligrams and Libtayo 350 milligrams intravenously every 3 weeks for 12 months, with a median follow up of 9 months and 5 months for the naïve and experienced cohorts, respectively. Efficacy results demonstrated an investigator-assessed objective response rate (ORR) of 27% (4 of 15 patients; all partial responses [PR]) in the naïve cohort and 7% in the experienced cohort (1 of 15 patients with a PR).

Additionally, exploratory analyses of the naïve cohort found the ORR was 50% (3 patients) among those who had not received any prior systemic therapy and 100% (3 patients) among those with tumors that had =50% PD-L1 expression. Median duration of response was not reached in the naïve cohort and was 5 months in the experienced cohort (95% confidence interval: not evaluable to not evaluable). In terms of safety for the naïve and experienced cohorts, rates of =grade 3 adverse events (AE) were respectively 33% (5 patients) and 40% (6 patients), while rates of serious AEs were respectively 20% (3 patients) and 13% (2 patients).

One patient in the naïve cohort and no patients in the experienced cohort discontinued treatment due to an AE; there were no treatment-related deaths reported in either cohort. Updated efficacy and safety data will be presented during a poster session (abstract #127P).