You are here

Opdivo Receives Expanded Lung Cancer Approval

Bristol-Myers Squibb drug approved for previously treated metastatic squamous and nonsquamous NSCLC

Nivolumab (Opdivo, Bristol-Myers Squibb) has received FDA approval for use in the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. This expands its indication for previously treated metastatic squamous NSCLC to include nonsquamous patients.

Approval was granted based on results from the phase III CheckMate-057 trial, which demonstrated superior overall survival (OS) benefit for nivolumab versus docetaxel in previously treated metastatic NSCLC.

CheckMate-057 is a comparative study designed to demonstrate survival. Clinical results were recently presented at the 2015 European Cancer Congress with simultaneous publication in the New England Journal of Medicine. The open-label, randomized clinical trial evaluated nivolumab (3 mg/kg administered intravenously every two weeks, n = 292) versus docetaxel (75 mg/m2 administered intravenously every three weeks, n = 290) in patients with metastatic nonsquamous NSCLC who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen. Appropriate targeted therapy may have been given to patients with known EGFR mutation or ALK translocation. The study included patients regardless of their PD-L1 (programmed death ligand-1) expression status. The primary endpoint of the trial was OS.

The median OS was 12.2 months in the nivolumab arm (95% confidence interval [CI], 9.7–15.0) and 9.4 months in the docetaxel arm (95% CI, 8.0–10.7). The hazard ratio (HR) was 0.73 (95% CI, 0.60–0.89; P = 0.0015), which translates to a 27% reduction in the risk of death with nivolumab compared to docetaxel. The prespecified interim analysis was conducted when 413 events were observed (93% of the planned number of events for final analysis).

Additional secondary endpoints include investigator-assessed objective response rate (ORR) and progression-free survival (PFS). The ORR in the nivolumab arm was 19% (56/292; four complete responses, 52 partial responses) (95% CI, 15–24) and 12% with docetaxel (36/290; one complete response, 35 partial responses) (95% CI, 9–17); P = 0.02. The median duration of response was 17 months in the nivolumab arm and 6 months in the docetaxel arm. Median PFS was 2.3 months in the nivolumab arm versus 4.2 months with docetaxel (HR = 0.92; 95% CI, 0.77–1.11; P = 0.39).

The safety profile of nivolumab in CheckMate-057 was consistent with prior studies. Serious adverse reactions occurred in 47% of patients receiving the medication. The most frequent serious adverse reactions in at least 2% of patients were pneumonia, pulmonary embolism, dyspnea, pleural effusions, and respiratory failure. Nivolumab was discontinued in 13% of patients and was delayed in 29% of patients for an adverse reaction. The most common adverse reactions (reported in at least 20% of patients) were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%), and constipation (23%).

Nivolumab is the only PD-1 therapy to have been studied in a phase III trial of patients with previously treated squamous NSCLC and a separate phase III trial of patients with previously treated nonsquamous NSCLC. Biomarker testing is not required for this product.

Source: BMS, October 9, 2015.

Recent Headlines

Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Artificial Intelligence Enables Platform to Detect Amyloid PET Status
Kadcyla Cut Risk of Recurring Disease by Half Compared to Herceptin
May Lead to Personalized Treatment for Schizophrenia, Other Illnesses
First Medicines for Adults With Wild-type or Hereditary ATTR-CM