On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene).
Efficacy was evaluated in a multicenter, randomized, open-label trial (Study 1624; NCT03088540) of 710 patients with locally advanced NSCLC who were not candidates for surgical resection or definitive chemoradiation or with metastatic NSCLC. Patients were randomized (1:1) to receive cemiplimab-rwlc 350 mg via IV infusion every three weeks for up to 108 weeks or a platinum-based chemotherapy. The main efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) per blinded independent central review (BICR).
The trial demonstrated statistically significant improvements in OS and PFS for patients receiving cemiplimab-rwlc compared to those treated with platinum-based chemotherapy. Median OS was 22.1 months (95% CI = 17.7, not evaluated) for patients in the cemiplimab-rwlc arm compared to 14.3 months (95% CI = 11.7, 19.2) in the chemotherapy arm (hazard ratio = 0.68; 95% CI = 0.53, 0.87, p = 0.0022). Median PFS per BICR was 6.2 months (4.5, 8.3) in the cemiplimab-rwlc arm and 5.6 months (4.5, 6.1) in the chemotherapy arm (hazard ratio = 0.59; 95% CI = 0.49, 0.72, p < 0.0001). Confirmed overall response rate per BICR was 37% (95% CI = 32, 42) and 21% (95% CI = 17, 25) in the cemiplimab-rwlc and chemotherapy arms, respectively.
The most common adverse reactions in more than 10% of patients were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.
The recommended cemiplimab-rwlc dose for treatment of NSCLC is 350 mg every three weeks, administered via IV infusion over 30 minutes.
View the full prescribing information for cemiplimab-rwlc.
The review used Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. FDA granted the application priority review. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.
For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.