FDA approves Libtayo with chemotherapy for advanced non-small cell lung cancer
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The FDA approved cemiplimab-rwlc in combination with platinum-based chemotherapy for first-line treatment of advanced non-small cell lung cancer.
Cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals), , a PD-1 inhibitor, previously had been approved as first-line monotherapy for patients with high PD-L1 expression.
The new indication applies to use by adults with advanced NSCLC with no EGFR, ALK or ROS1 aberrations. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation.
"This second FDA approval for cemiplimab-rwlc in advanced non-small cell lung cancer greatly broadens the scope in which a cemiplimab-rwlc-based regimen can be prescribed to encompass a wide range of patients, either as single agent in those with [PD-L1 expression of at least 50%] or now in combination with chemotherapy irrespective of PD-L1 expression or tumor histology," David R. Gandara, MD, professor emeritus and senior advisor of the thoracic oncology program at UC Davis Comprehensive Cancer Center, said in a Regeneron-issued press release.
The FDA based the new indication on results of the randomized phase 3 EMPOWER-Lung 3 trial, which investigated cemiplimab-rwlc in combination with physician’s choice of platinum-doublet chemotherapy.
The trial enrolled 466 patients with locally advanced or metastatic NSCLC, irrespective of PD-L1 expression or tumor histology and with no ALK, EGFR or ROS1 aberrations.
Researchers randomly assigned patients to 350 mg cemiplimab-rwlc (n = 312) or placebo (n = 154) via IV every 3 weeks, plus histology-specific platinum-doublet chemotherapy.
OS served as the primary endpoint.
Researchers stopped the trial early based on a recommendation by the independent data monitoring committee after the combination demonstrated a significant improvement in OS (median, 21.9 months vs. 13 months; HR = 0.71; 95% CI, 0.53- 0.93).
Researchers reported median PFS of 8.2 months with the combination and 5 months with chemotherapy alone (HR = 0.56; 95% CI, 0.44-0.7).
The most common adverse events that occurred among at least 15% of patients assigned cemiplimab-rwlc included alopecia (37% with combination vs. 43% plus chemotherapy alone), musculoskeletal pain (30% vs. 36%), nausea (25% vs. 16%), fatigue (23% vs. 18%), peripheral neuropathy (23% vs. 19%) and decreased appetite (17% vs. 12%).
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