FDA Approves Libtayo Plus Chemotherapy for Advanced Lung Cancer Subset

The Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc) plus platinum-based chemotherapy to treat adults with non-small cell lung cancer without EGFR, ALK or ROS1 mutations, according to the agency.

The approval was based off findings from the randomized Study 16113, which included 466 patients with advanced NSCLC who had not yet taken any drugs to treat their disease. Two-thirds of patients were randomly assigned to receive Libtayo plus chemotherapy, while the other third was assigned to receive placebo plus chemotherapy.

The main goal of the study was to determine if the Libtayo-containing regimen could lead to an improved average overall survival (time from treatment until death of any cause), which it did. The average overall survival for the Libtayo group was 21.9 months, compared to 13 months for the placebo group. Patients in the Libtayo group also had a longer time until their disease got worse (a statistic known as progression-free survival), at 8.2 months, compared to five months, respectively.

Additionally, more patients responded to the Libtayo-containing regimen than the placebo-chemotherapy regimen, with response rates of 43% and 23%, respectively.

The most common side effects that occurred in 15% or more of patients in the Libtayo group were: hair loss, musculoskeletal pain, nausea, fatigue, peripheral neuropathy and decreased appetite.

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