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FDA to Review Libtayo for Frontline Advanced NSCLC


After promising phase 3 clinical trial results, the FDA will consider Libtayo for approval to treat patients with advanced non-small cell lung cancer, regardless of PD-L1 status.

The Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) of Libtayo (cemiplimab-rwlc) plus chemotherapy for the frontline treatment of patients with advanced non-small cell lung cancer (NSCLC).

In doing so, the FDA agreed to review the drug in this setting and has set a goal to decide on whether it should be approved by Sept. 19, 2022.

The sBLA was granted based on promising results from a randomized phase 3 trial including 466 patients with locally advanced or metastatic NSCLC that analyzed Libtayo plus physician’s choice of platinum-doublet chemotherapy compared with the platinum-doublet chemotherapy alone. Enrollment in the trial was not dependent on patients’ PD-L1 expression or tumor histology, but to be eligible, individuals could not have ALK, EGFR or ROS1 aberrations.

The clinical trial was actually stopped early because researchers saw such a significant improvement in overall survival for patients in the Libtayo-containing group compared with those only given chemotherapy. Results presented at the European Society for Medical Oncology Virtual Congress 2021 showed that Libtayo — a PD-1 inhibitor — improved average overall survival to 22 months (versus 13 months in the chemotherapy group) and progression-free survival, defined as the time a patient lives without their disease getting worse, to eight months (compared to five months).

The researchers in the trial aimed to use a patient population that they would typically see in everyday clinical practice. In the study population, 43% of patients had tumors with squamous histology; 67% had tumors with less than 50% PD-L1 expression; 15% had inoperable locally advanced disease that was not eligible for definitive chemoradiation; and 7% had pretreated and clinically stable brain metastases.

Most patients had an ECOG performance status — which measures everyday functionality — of 1, which indicates a restriction in physically strenuous activity but an ability to perform tasks such as office work.

The Libtayo group did have a slightly higher rate of discontinuation due to treatment-related side effects, compared to the chemotherapy-only group (5% versus 3%, respectively). Since Libtayo works by sparking the immune system to find and fight cancer cells, 19% of patients on the therapy reported immune-related side effects.

Libtayo was previously approved by the FDA in February 2021 for the treatment of patients with advanced NSCLC that was not eligible for surgical resection or chemoradiation, had no EGFR, ALK or ROS1 mutations and the disease had a PD-L1 expression of 50% or higher.

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