Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval.
On November 8, 2022, the FDA approved cemiplimab-rwlc (brand name Libtayo,) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no epidermal growth factor gene, anaplastic lymphoma kinase, or ROS-1 aberrations.
Efficacy was evaluated in Study 16113, a randomized, multicenter, multinational, double-blind, active-controlled trial in 466 patients with advanced non-small cell lung cancer who had not received prior systemic treatment. Patients were randomized (2:1) to either cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by cemiplimab-rwlc and maintenance chemotherapy or placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.
The main efficacy outcome measure was overall survival. Additional efficacy outcome measures were progression-free survival and overall response rate as assessed by blinded independent central review.
Cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy. Median overall survival was 21.9 months in the cemiplimab-rwlc plus chemotherapy arm and 13.0 months in the placebo plus chemotherapy arm. Median progression-free survival per blinded independent central review was 8.2 months in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months in the placebo plus chemotherapy arm. Confirmed overall response rate per blinded independent central review was 43% and 23% in the respective treatments.
The most common adverse reactions occurring in more than 15% of patients were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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