Nivolumab Improved OS in SCCHN; CheckMate-141 Stopped Early

Bristol-Myers Squibb (BMS) has announced that a phase 3 trial evaluating its programmed cell death protein 1 (PD-1) inhibitor, nivolumab, in patients with squamous cell carcinoma of the head and neck (SCCHN) has been stopped early. A review by an independent Data Monitoring Committee, says the press release, found that nivolumab improved overall survival (OS) in SCCHN patients compared with the control arm.

According to ClinicalTrials.gov, the study (called CheckMate-141) was designed to query whether nivolumab could improve OS in patients with recurrent or metastatic head and neck carcinoma. The study, which was initiated in May 2014, had an estimated primary completion date of October 2016. With nivolumab in the experimental arm, the active comparator arms in CheckMate-141—which is an open-label, randomized study—included investigator’s choice of either cetuximab or methotrexate or docetaxel. The trial randomized 361 participants to either receive 3 mg/kg nivolumab every 2 weeks or one of the drugs in the comparator arm, until disease progression or unacceptable toxicity. With OS as the primary outcomes measure, secondary outcomes measures included progression-free survival and objective response rate.

Michael Giordano, MD, senior vice president, head of Oncology Development, BMS, said in the press release, “With the results of CheckMate-141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options. We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer.”

BMS has informed investigators to stop the trial early, and the company plans to share the data with the FDA soon.

Thus far, nivolumab has been approved for advanced renal cell carcinoma, frontline in BRaf wild type and mutated melanoma, and for squamous and non-squamous non—small cell lung cancer.