Sanofi’s NSCLC drug gains EC approval
pharmafile | June 25, 2021 | News story | Medical Communications | EC, EU, NSCLC, Sanofi
The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK, or ROS1 aberrations.
Libtayo is now approved for three advanced cancers in the European Union. The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor.
The approval is based on a global Phase III trial that enrolled 710 patients from 24 countries. The trial, which was one of the largest for a PD-1 inhibitor in advanced NSCLC, was designed to be more reflective of clinical practice by including challenging-to-treat and often underrepresented disease characteristics.
In the overall study population, Libtayo significantly reduced the risk of death by 32% and extended median overall survival by eight months compared to chemotherapy, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy.
Peter C. Adamson, Global Development Head of Oncology at Sanofi, said: “We are confident that Libtayo has the potential to become an important treatment option for patients in the European Union and thank all the investigators, patients, and their families who helped us reach this milestone.
“We are anticipating results from our ongoing Phase III trial of Libtayo plus chemotherapy in patients with advanced non-small cell lung cancer and remain committed to studying Libtayo in additional cancer settings where there is the potential to improve the outcome for patients.”
In 2019, Libtayo was approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Across all of its approved indications, Libtayo had a generally consistent safety profile. However, immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.
Kat Jenkins
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