The positive opinion was adopted on the basis of a phase 3 trial that showed superior survival outcomes for Libtayo plus chemotherapy compared to chemotherapy alone
Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Libtayo (cemiplimab) in combination with platinum-based chemotherapy.
The Libtayo combination has been recommended for approval in the European Union (EU) by CHMP for first-line treatment of adults having advanced non-small cell lung cancer (NSCLC) with PD-L1 expression of ≥1%.
Discovered by using Regeneron’s proprietary VelocImmune technology, Libtayo is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells.
The positive opinion of the CHMP was adopted on the basis of results from the global EMPOWER-Lung 3 phase 3 trial. It included a patient population with a variety of disease presentations that doctors manage in daily clinical practice.
US-based Regeneron said that the primary analysis was conducted with a median follow-up of 16 months.
The results showed a statistically significant increase in overall survival (OS) for patients treated with the Libtayo combination compared to chemotherapy alone in the overall population.
Out of 466 enrolled patients, 327 patients were having tumours expressing PD-L1 ≥1%. In this population, the Libtayo combination was compared to chemotherapy alone.
The efficacy results demonstrated a 22-month versus 13-month median OS with a median follow-up of 16 months. This was equal to a 45% of relative reduction in the risk of death in the trial.
Additionally, the investigational combination showed a continued clinically meaningful survival benefit with a median duration of follow-up of 28 months, the pharmaceutical firm added.
EMPOWER-Lung 3 was a randomised, multicentre trial that compared Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy, with platinum-doublet chemotherapy alone.
In the upcoming months, the European Commission is anticipated to decide on the application for the Libtayo, chemotherapy combination.
The US Food and Drug Administration (FDA) authorised the Libtayo combination in November 2022 for advanced NSCLC regardless of PD-L1 expression.
Libtayo is approved for the treatment of certain patients with advanced cervical cancer, advanced NSCLC, advanced basal cell carcinoma, and advanced cutaneous squamous cell carcinoma (CSCC) in the European Union and other countries.