FDA Approves Opdivo for Lung Cancer

The Food and Drug Administration has approved the anti–PD-1 agent Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). The approval comes three months ahead of the FDA's scheduled decision date.

The Food and Drug Administration has approved the anti—PD-1 agent Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). The approval comes three months ahead of the FDA’s scheduled decision date.

The approval is based on data from the phase 3 CheckMate-017 trial in which Opdivo improved overall survival by 3.2 months versus docetaxel in previously treated patients with advanced or metastatic squamous cell NSCLC.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”

The CheckMate-017 study involved 272 previously treated patients with advanced or metastatic squamous cell NSCLC. Participants were randomized to the fully human IgG4 monoclonal antibody Opdivo at 3 mg/kg intravenously every two weeks or docetaxel at 75 mg/m2 intravenously every three weeks.

Beyond the primary OS endpoint, secondary endpoints included progression-free survival and objective response rate (ORR).

Bristol Myers Squibb, the manufacturer of Opdivo is working on a timetable for publication and presentation of the study data. The approval was also supported by data from the open-label, single-arm, phase 2 CheckMate-063 study of Opdivo in NSCLC, which were presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology.

The study included 117 heavily pretreated patients with advanced squamous cell NSCLC. All patients had cancer that progressed following two or more systemic treatments and 65 percent of participants had three or more treatments. Seventy-six percent of patients were within three months of completion of their most recent therapy.

Opdivo was administered at 3 mg/kg intravenously every two weeks until disease progression or treatment discontinuation. The estimated one-year survival rate was 41 percent and the median OS was 8.2 months.

An additional 26 percent of patients had stable disease for a median duration of six months, producing a disease control rate (ORR plus stable disease) of 41 percent. Responses were observed independent of PD-L1 status for patients with quantifiable PD-L1 expression.

Adverse events (AEs) of all types and grades occurred in 74 percent of patients; however, 85 percent of patients were able to receive at least 90 percen of their planned dose intensity.

The most common moderate to severe side effects were fatigue, pneumonitis and diarrhea. Two drug-related deaths occurred in patients with multiple comorbidities and progressive disease.

The FDA announced at the end of February that it had granted a priority review to Opdivo for use in patients with previously treated, advanced, squamous NSCLC. Opdivo was initially approved in December 2014 for patients with unresectable or metastatic melanoma following treatment with Yervoy (ipilimumab) or a BRAF inhibitor.