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FDA Expands Opdivo (Nivolumab) Labeling to Include NSCLC

Treatment reduces mortality risk by 41% compared with docetaxel

The FDA has given the green light to Opdivo (nivolumab, Bristol-Myers Squibb) injection, for intravenous (IV) use, for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Opdivo is the first programmed death receptor-1 (PD-1) therapy to demonstrate overall survival in patients with previously treated metastatic squamous NSCLC. The treatment achieved significantly superior overall survival (OS) compared with docetaxel

This approval is the second for Opdivo in the U.S. within 3 months. The drug was previously approved for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. The new approval for NSCLC was based on results from the CheckMate-017 and CheckMate-063 trials.

CheckMate-017 was a phase III, open-label, randomized, multinational study that evaluated nivolumab (3 mg/kg IV over 60 minutes every 2 weeks) (n = 135) compared with standard-of-care docetaxel (75 mg/m2 IV administered every 3 weeks) (n = 137) in patients with metastatic squamous NSCLC who had progressed during or after a prior platinum doublet-based chemotherapy regimen. The study included patients regardless of their programmed death ligand-1 (PD-L1) status. The trial’s primary endpoint was OS.

In January, the study was stopped based on an assessment conducted by an independent data-monitoring committee, which concluded that the study met its endpoint, demonstrating superior OS in patients receiving nivolumab compared with those treated with docetaxel. The prespecified interim analysis was conducted when 199 events (86% of the planned number of events for the final analysis) were observed (86 in the nivolumab arm and 113 in the docetaxel arm).

Opdivo is the only FDA-approved monotherapy to demonstrate superior OS compared with standard of care in more than 15 years in patients with previously treated metastatic squamous NSCLC. The median OS was 9.2 months in the nivolumab arm and 6.0 months in the docetaxel arm. The hazard ratio was 0.59 (P = 0.00025). This hazard ratio translates to a 41% reduction in the risk of death with nivolumab compared with docetaxel.

The safety profile of nivolumab in patients with squamous NSCLC was established in the CheckMate-063 trial, a phase II single-arm, open-label, multinational study of nivolumab administered as a single agent in 117 patients with metastatic squamous NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen. The patients received 3 mg/kg of nivolumab IV administered over 60 minutes every 2 weeks. The trial included patients regardless of their PD-L1 status.

The most common adverse events (AEs) included fatigue (50%), dyspnea (38%), musculoskeletal pain (36%), decreased appetite (35%), cough (32%), nausea (29%), and constipation (24%). Serious AEs occurred in 59% of patients receiving nivolumab. The most common serious AEs included dyspnea, pneumonia, exacerbation of chronic obstructive pulmonary disease, pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain. Nivolumab was discontinued because of AEs in 27% of patients. Twenty-nine percent of patients receiving nivolumab had a drug delay for an AE.

With at least 10 months of minimum follow-up for all patients, the confirmed objective response rate, the study’s primary endpoint, was 15% (17/117); all were partial responses. The median time to onset of a response was 3.3 months (range: 1.7 to 8.8 months) after the start of nivolumab treatment. Seventy-six percent of nivolumab responders (13/17 patients) had ongoing responses, with the durability of response ranging from 1.9+ to 11.5+ months; 10 of these 17 patients (59%) had durable responses of 6 months or longer.

Sources: Bristol-Myers Squibb; March 5, 2015; and FDA; March 4, 2015.


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