Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
October 12, 2018
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Phase 3 study of nivolumab for small cell lung cancer fails to meet primary endpoint

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A phase 3 study of nivolumab compared with chemotherapy failed to meet its primary endpoint of OS among patients with small cell lung cancer who relapsed following platinum-based chemotherapy, according to the agent’s manufacturer.

The safety profile was consistent with previous trials of nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, among patients with small cell lung cancer.

CheckMate-331 is an open-label, randomized trial assessing nivolumab monotherapy compared with current standard-of-care topotecan or amrubicin. All patients had relapsed following platinum-based chemotherapy.

OS served as the primary endpoint and was not reached. Secondary endpoints included PFS and objective response rate.

“Small cell lung cancer is a highly aggressive disease in which significant unmet need remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer,” Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “We thank the patients, their families and the physicians involved in the CheckMate-331 study.”

The FDA approved nivolumab for the treatment of patients with metastatic small cell lung cancer who progressed after platinum-based chemotherapy and at least one other line of therapy in August based on results from the CheckMate-032 study.

Nivolumab also is indicated for the treatment of certain patients with metastatic non-small cell lung cancer and certain patients with recurrent or metastatic squamous cell carcinoma of the head and neck.