Regeneron to Showcase Oncology Portfolio Progress at WCLC and ESMO

Regeneron Pharmaceuticals, Inc. has announced significant data presentations from its oncology portfolio at two major conferences: the IASLC 2024 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) Annual Meeting. The company will showcase 11 presentations that highlight its commitment to advancing cancer care, particularly for hard-to-treat cancers such as advanced melanoma, advanced non-melanoma skin cancer, and various types of lung cancer.

Dr. Israel Lowy, Regeneron's Clinical Development Unit Head for Oncology, emphasized the company's progress in cancer treatment innovations. At WCLC, five-year data on Libtayo (cemiplimab) as a first-line monotherapy for advanced non-small cell lung cancer (NSCLC) will be presented, reinforcing its role as a cornerstone in Regeneron's oncology portfolio. Meanwhile, at ESMO, two-year results of the investigational combination of fianlimab (a LAG-3 inhibitor) and Libtayo in advanced melanoma will be showcased, demonstrating prolonged clinical activity and deepening tumor responses.

The ESMO presentation will feature the investigational combination's efficacy in advanced melanoma patients. The combination is being further evaluated in a randomized, placebo-controlled Phase 3 trial versus pembrolizumab in untreated locally advanced or metastatic melanoma. The initial trial's longer-term results, based on a median follow-up of 23 months and 35 weeks of treatment, indicate persistent and deepening tumor responses across three independent cohorts:

- In the MM1 cohort (n=40), there was a 23% complete response (CR) rate and a 60% objective response rate (ORR).
- In the MM2 cohort (n=40), there was a 25% CR rate and a 63% ORR.
- In the MM3 cohort (n=18, including patients with prior systemic therapy who progressed despite anti-PD-1 treatments), there was a 28% CR rate and a 39% ORR.

A post-hoc analysis of all three cohorts combined showed a 25% CR rate and a 57% ORR. Initial progression-free survival (PFS) and overall survival (OS) assessments from this single-arm trial support the ongoing Phase 3 trial's evaluation of these endpoints for the combination therapy.

Safety data for the combination treatment revealed a profile consistent with Libtayo monotherapy and other anti-PD-(L)1 agents, though higher rates of treatment-related adrenal insufficiency (12%, with 5% at Grade 3 or higher) were noted. Adverse events (AEs) of any grade occurred in 95% of patients, with 47% experiencing Grade 3 or greater AEs, 36% reporting serious AEs, and 13% experiencing immune-mediated AEs. Seven patients had AEs that led to death, with two considered treatment-related.

Regeneron's presentations at WCLC will include multiple topics:

- Libtayo monotherapy for first-line advanced NSCLC patients with high PD-L1 expression: five-year outcomes.
- Prognostic utility of peripheral myeloid cells for clinical outcomes in NSCLC patients treated with cemiplimab.
- Real-world comparative effectiveness in advanced NSCLC with high PD-L1 using first-line immune checkpoint inhibitors with or without chemotherapy.
- Various combination therapies involving fianlimab in advanced NSCLC, including trials in progress updates.

At ESMO, Regeneron will present updated data on Libtayo's efficacy in Japanese patients with advanced NSCLC and a risk model for overall survival based on patient-reported outcomes in NSCLC patients treated with first-line cemiplimab-based therapy. Additional presentations will cover davutamig (REGN5093) for MET-altered advanced NSCLC and the long-term follow-up of fianlimab and Libtayo in advanced melanoma.

Libtayo, developed using Regeneron's VelocImmune technology, targets the immune checkpoint receptor PD-1 on T cells, blocking cancer cells from suppressing T-cell activation. It is approved for various indications in the U.S. and other countries, including advanced basal cell carcinoma, cutaneous squamous cell carcinoma, and NSCLC. The investigational uses of Libtayo in combination therapies, as well as other Regeneron assets like fianlimab and REGN7075, are under ongoing research and have not yet received regulatory approval.