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FDA Approves BMS' Opdivo, Yervoy With CDx in First-Line PD-L1-Expressing Lung Cancer

NEW YORK – Bristol Myers Squibb said on Friday that the US Food and Drug Administration approved the combination of PD-1 inhibitor nivolumab (Opdivo) and CTLA-4 inhibitor ipilimumab (Yervoy) as a first-line treatment for PD-L1 expressing, metastatic non-small cell lung cancer with no EGFR or ALK mutations, as determined by an FDA-approved test.

The FDA also approved the PD-L1 IHC 28-8 pharmDx by Agilent Technologies as a companion diagnostic device for selecting NSCLC patients for treatment with the nivolumab and ipilimumab combination.

The combination calls for 3 mg/kg of nivolumab combined with 1 mg/kg of ipilimumab to be injected intravenously.

The approval was based on the part 1a results from the Phase III CheckMate-227 trial.

In patients with PD-L1 expression in 1 percent or more tumor cells and treated with the nivolumab/ipilimumab combination, the three-year overall survival rate was 33 percent compared to 22 percent for those who only received chemotherapy. Patients treated with the combination regimen had a three-year progression-free survival rate of 18 percent compared to 4 percent in those treated with chemotherapy alone.

In the PD-L1-positive group who saw their tumors shrink on the nivolumab and ipilimumab combination, 38 percent continued to respond to the drug for three years. Comparatively, 4 percent of responders in the chemotherapy-only arm remained in response three years later.

In the CheckMate-227 trial, serious adverse reactions occurred in 58 percent of patients, 24 percent of patients discontinued treatment due to adverse reactions, and 1.7 percent of patients had a fatal adverse reaction.

The most frequent adverse reactions reported were pneumonia, diarrhea or colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency and hypophysitis.

This is the fifth indication approved by the FDA for this drug combination.