Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to chemotherapy alone

TARRYTOWN, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

The European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.

The positive opinion is supported by results from the global Phase 3 EMPOWER-Lung 3 trial, which was designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice. At the primary analysis with a median follow-up of 16 months, the trial showed a statistically significant improvement in overall survival (OS) for patients treated with the Libtayo combination (n=312) compared to chemotherapy alone (n=154) in the overall population (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93).

Among the 466 patients enrolled in the trial, 70% of patients (n=327) had tumors expressing PD-L1 ≥1%. Comparing the Libtayo combination (n=217) to chemotherapy alone (n=110), efficacy results in this population showed a:

• 22-month versus 13-month median OS with a median follow-up of 16 months. This represented a 45% relative reduction in the risk of death in the trial (HR: 0.55; 95% CI: 0.39 to 0.78).
• Continued clinically meaningful survival benefit with a median duration of follow-up of 28 months (HR: 0.51; 95% CI: 0.38 to 0.69).

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo. Among those measured for safety in the trial (n=465), adverse reactions occurring in at least 10% of patients included anemia (44%), alopecia (37%), musculoskeletal pain (27%), nausea (25%), fatigue (23%), peripheral neuropathy (21%), hyperglycemia (18%), decreased appetite (17%), alanine aminotransferase increased (16%), aspartate aminotransferase increased (15%), neutropenia (15%), constipation (14%), dyspnoea (13%), rash (13%), thrombocytopenia (13%), vomiting (12%), diarrhea (11%), insomnia (11%), weight decreased (11%) and hypoalbuminemia (10%). Adverse events were serious in 25% of patients and led to permanent discontinuation of Libtayo in 5% of patients.

Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.

About the Phase 3 TrialEMPOWER-Lung 3 was a randomized, multicenter Phase 3 trial investigating Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, as well as squamous or non-squamous histologies across all PD-L1 expression levels and with no ALK, EGFR or ROS1 aberrations.

Among those enrolled, 43% had tumors with squamous histology, 15% had locally advanced disease, and 7% had a history of brain metastases. Patients were randomized 2:1 to receive either Libtayo or placebo, plus histology-specific platinum-doublet chemotherapy. The trial was stopped early based on a recommendation by the Independent Data Monitoring Committee (IDMC) after the Libtayo and chemotherapy combination demonstrated a significant improvement in overall survival, the primary endpoint. Results of the trial at the primary endpoint were published in Nature Medicine in August 2022.

In December 2022, Libtayo in combination with chemotherapy was added to the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (score: 4 out of 5), for patients with advanced NSCLC across squamous and non-squamous histologies, and irrespective of PD-1 expression levels.

About NSCLCLung cancer is the leading cause of cancer death worldwide. In recent years, more than 2.2 million annual new cases have been diagnosed globally. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. Additionally, 70% of all NSCLC cases will have