2024 World Conference on Lung Cancer (WCLC) - Posters-P4.11D.09 Fianlimab-Based Combination Therapies in Patients with Advanced Non-Small Cell Lung Cancer: Trials in Progress Updates

P4.11D.09 Fianlimab-Based Combination Therapies in Patients with Advanced Non-Small Cell Lung Cancer: Trials in Progress Updates

Back to course

Pdf Summary

The document provides an update on ongoing clinical trials for fianlimab-based combination therapies in patients with advanced non-small cell lung cancer (NSCLC). The key studies mentioned are HARMONY LUNG-1 and HARMONY LUNG-2, which are investigating the efficacy of combining fianlimab (an anti–LAG-3 monoclonal antibody) with cemiplimab (an anti–PD-1 therapy) compared to cemiplimab monotherapy and in combination with chemotherapy. These trials are open for enrollment and globally conducted at 210 sites.<br /><br />The goal of these randomized, double-blind, multicenter Phase 2/3 studies is to assess the clinical activity and safety of these combination therapies. HARMONY LUNG-1 focuses on patients with high PD-L1 expression (≥50%), while HARMONY LUNG-2 includes patients regardless of PD-L1 expression, aiming to evaluate the treatment in both treatment-naïve and chemo-naïve settings. The trials will explore endpoints such as overall response rate (ORR), progression-free survival (PFS), and overall survival (OS), along with safety and tolerability.<br /><br />Preliminary results have shown promising clinical activity in advanced NSCLC patients naïve to anti–PD-1/PD-L1 treatments, with an ORR of 26.7% in an earlier study. The trials are sponsored by Regeneron Pharmaceuticals, and medical writing support was provided to adhere to good publication practice.<br /><br />These trials aim to address the challenges of resistance to existing PD-1 therapies by enhancing efficacy through additional immune pathway targeting with LAG-3 blockade, potentially offering improved outcomes for patients with advanced NSCLC.

Asset Subtitle

Ana Baramidze

Meta Tag

Speaker Ana Baramidze

Topic Metastatic NSCLC – Immunotherapy

Keywords

fianlimab

NSCLC

HARMONY LUNG-1

HARMONY LUNG-2

cemiplimab

clinical trials

PD-L1 expression

Regeneron Pharmaceuticals

LAG-3 blockade

combination therapies