Cemiplimab (Libtayo) has garnered FDA approval for the first-line treatment of patients with non-small cell lung cancer (NSCLC) with tumors with high PD-L1 expression, according to a statement from Regeneron Pharmaceuticals and Sanofi.
“[Cemiplimab] has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1 expression in its pivotal trial,” said Ahmet Sezer, MD, of Başkent University in Adana, Turkey, who was a trial investigator. “As published in The Lancet, in a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, [cemiplimab] reduced the risk of death by 43% compared to chemotherapy. This was achieved with a greater than 70% crossover rate to [cemiplimab] following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced NSCLC pivotal trials to date.”
In the phase III randomized trial, cemiplimab was pitted against chemotherapy. The researchers assessed safety at a median 27 weeks and found that patients in the cemiplimab group had more adverse events than those in the chemotherapy group, with rash and cough being the most common. As for serious adverse events, 2% of the nearly 700 patients in the two groups reported pneumonia (5% cemiplimab; 6% chemotherapy), and pneumonitis (2% cemiplimab; 0% chemotherapy). Six percent of the cemiplimab patients discontinued treatment due to adverse reactions.
This marks the third approved indication for cemiplimab, following just weeks after the drug’s approval for the treatment of patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom HHI is not appropriate. Cemiplimab was first approved in 2018 for the treatment of adults with advanced cutaneous squamous cell carcinoma.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 24
Topic ID: 78,24,730,24,192,65,925
