Sanofi-Regeneron’s NSCLC trial of Libtayo stops early over survival benefit

August 6, 2021 (Last Updated August 6th, 2021 10:38)

The move is based on the Independent Data Monitoring Committee recommendation during an interim analysis.

Sanofi-Regeneron’s NSCLC trial of Libtayo stops early over survival benefit
The trial enrolled patients with squamous or non-squamous advanced non-small cell lung cancer. Credit: Robina Weermeijer on Unsplash.

Sanofi and Regeneron Pharmaceuticals have stopped their Phase III EMPOWER-Lung 3 clinical trial of Libtayo early after the study met the primary endpoint of overall survival (OS) in advanced non-small-cell lung cancer (NSCLC) patients.

When administered in combination with platinum-doublet chemotherapy, the drug led to a significant OS improvement from 13 to 22 months versus chemotherapy alone.

Participants had metastatic or locally advanced disease and tumours with squamous or non-squamous histology of any programmed death-ligand 1 (PD-L1) expression level.

The Independent Data Monitoring Committee (IDMC) recommended that the Phase III trial can stop early in a pre-specified interim analysis.

Data from top-line preliminary analysis in 466 patients showed a 29% decrease in the death risk when compared with only chemotherapy.

The median OS with Libtayo plus chemotherapy was 22 months while it was 13 months with chemotherapy alone.

Any new Libtayo-related safety signals were not observed in the IDMC analysis.

The EMPOWER-Lung 3 trial results are expected to support regulatory filings in the US and the EU.

Trial investigator Miranda Gogishvili said: “Notably, the Phase III trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease.

“These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also includes the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression.”

Libtayo is a fully human monoclonal antibody that acts on the immune checkpoint receptor PD-1 present on T-cells. It attaches to PD-1 and could hinder cancer cells from leveraging the PD-1 pathway to suppress the activation of T-cells.

EMPOWER-Lung 3 assessed 350mg Libtayo plus platinum-doublet chemotherapy versus placebo plus chemotherapy, given every three weeks for four cycles.

Apart from OS, progression-free survival is a primary goal of the trial, which also assessed objective response rate and best overall response as the main secondary endpoints.

In March, Sanofi and Regeneron reported positive data from the Phase III trial investigating Libtayo for treating cervical cancer.