FDA approves Libtayo for NSCLC subset
The FDA approved cemiplimab-rwlc monotherapy as first-line treatment for certain patients with advanced non-small cell lung cancer.
The approval applies to use of the agent for patients with high PD-L1 expression — defined as tumor proportion score of 50% or higher — as determined by an FDA-approved test. Patients also must have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and tumors must not have EGFR, ALK or ROS1 aberrations.
Cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals, Sanofi) is a PD-1 inhibitor.
The FDA based the approval on results of the randomized phase 3 EMPOWER-Lung 1 trial, which compared first-line cemiplimab-rwlc monotherapy with platinum-doublet chemotherapy for patients with untreated metastatic or locally advanced NSCLC. All 710 patients had PD-L1 in at least 50% of tumor cells, and no patients had EGFR, ALK or ROS1 aberrations.
Twelve percent of patients had pretreated and clinically stable brain metastases, and 16% had locally advanced NSCLC that was not a candidate for definitive chemoradiation.
Researchers randomly assigned 356 patients to cemiplimab-rwlc dosed at 350 mg every 3 weeks. The other 354 patients received chemotherapy.
OS and PFS served as primary endpoints.
As Healio previously reported, results showed longer median OS (22 months vs. 14 months; HR = 0.68; 95% CI, 0.53-0.87) and PFS (6.2 months vs. 5.6 months; HR = 0.59; 95% CI, 0.49-0.72) in the cemiplimab-rwlc group.
Trial protocol allowed patients assigned chemotherapy to cross over to cemiplimab-rwlc upon disease progression. Those who progressed on cemiplimab-rwlc monotherapy were allowed to combine that treatment with four to six cycles of chemotherapy. More than 70% of patients who progressed on chemotherapy crossed over to cemiplimab-rwlc monotherapy.
“The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease," trial steering committee member Naiyer Rizvi, MD, Price family professor of medicine, director of thoracic oncology and co-director of cancer immunotherapy at Columbia University Irving Medical Center, said in a press release issued by Regeneron and Sanofi. “Notably, Libtayo was approved based on a pivotal trial where most [patients assigned chemotherapy] crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”
Adverse events that occurred more frequently in the cemiplimab-rwlc group included rash (15% vs. 6%) and cough (11% vs. 8%). The most common serious adverse events included pneumonia (5% for cemiplimab-rwlc vs. 6% for chemotherapy) and pneumonitis (2% vs. 0%).
Six percent of patients assigned cemiplimab-rwlc discontinued treatment due to adverse events. Events that prompted discontinuation included pneumonitis, pneumonia, ischemic stroke and increased aspartate aminotransferase.
The FDA previously granted priority review to cemiplimab-rwlc for this indication. The agent also is approved in the United States for treatment of certain patients with basal cell carcinoma and advanced cutaneous squamous cell carcinoma.