Regeneron Gets FDA Review for Non-Small Cell Lung Cancer Treatment
Regeneron’s non-small cell lung cancer treatment, Libtayo, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.
Source: FDA Official
By - FDA recently accepted for review Regeneron’s biologics license application for its PD-1 inhibitor, Libtayo, in combination with chemotherapy to treat advanced non-small cell lung cancer (NSCLC).
A Phase 3 trial investigating Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy, compared to chemotherapy alone, supported Regeneron’s application.
Notably, the trial enrolled 466 patients with locally advanced or metastatic NSCLC with no ALK, EGFR, or ROS1 aberrations and was designed to include baseline characteristics seen in everyday clinical practices.
About 43 percent of patients had tumors with squamous histology, 67 percent had over 50 percent PD-L1 expression, 15 percent had inoperable locally advanced disease not eligible for chemotherapy, and seven percent had pretreated and stable brain metastases.
Treatment discontinuation occurred in five percent and three percent of patients in the Libtayo combination and chemotherapy alone groups, respectively.
Regeneron recently submitted the trial results to the European Medicines Agency (EMA).
Lung cancer is the leading cause of cancer death worldwide. Over 235,000 annual new cases are diagnosed in the US and 2.2 million diagnosed globally. And about 84 percent of all lung cancers are NSCLC, with 75 percent of these cases diagnosed in advanced stages.
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.
Regeneron discovered Libtayo using its proprietary Veloclmmune technology. Currently, Regeneron and Sanofi are jointly developing the treatment under a global collaboration agreement.
Last year, FDA and the European Union approved Libtayo as a first-line monotherapy treatment for adults with advanced NSCLC whose tumors have high PD-L1 expression. The drug is also FDA approved for patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced NSCLC.
Additionally, researchers are studying Libtayo as a monotherapy and combining either conventional or novel therapeutic approaches for other solid tumors and blood cancers.
In June 2021, FDA approved Amgen’s Lumakras to treat adults with NSCLC whose tumors have a specific type of genetic mutation and have received at least one prior systemic therapy.
Lumakras is the first FDA-approved targeted NSCLC therapy.
