Bristol-Myers Squibb has announced the early closure of its CheckMate-141 trial because it has already met its primary endpoint, per an assessment conducted by an independent Data Monitoring Committee.
The pivotal phase 3 trial demonstrated superior overall survival with nivolumab (Opdivo) compared with investigator’s choice of treatment in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).1
“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,” said Michael Giordano, MD, senior vice president, head of Oncology Development, Bristol-Myers Squibb.
CheckMate-141 is an open-label study that evaluated nivolumab compared with investigator’s choice of therapy. A total of 361 participants with SCCHN who experienced disease progression on or within 6 months of platinum therapy were randomly assigned 2:1 to receive nivolumab 3 mg/kg intravenously every 2 weeks, or cetuximab, methotrexate, or docetaxel until disease progression or unacceptable toxicity.
The primary endpoint is overall survival with objective response rate and progression-free survival as secondary endpoints.
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody already approved by the U.S. Food and Drug Administration for the treatment of BRAF V600 wild-type or mutation-positive unresectable or metastatic melanoma as monotherapy, unresectable or metastatic melanoma in combination with ipilimumab, metastatic non-small cell lung cancer after progression on or after platinum-based chemotherapy, and advanced renal cell carcinoma after prior antiangiogenic therapy.
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In terms of safety, rash, musculoskeletal pain, constipation, diarrhea, and decreased appetite are frequently reported with single-agent nivolumab treatment.
- CheckMate -141, a pivotal phase 3 Opdivo (nivolumab) head and neck cancer trial, stopped early [news release]. Princeton, NJ: Bristol-Myers Squibb; January 28, 2016. http://news.bms.com/press-release/checkmate-141-pivotal-phase-3-opdivo-nivolumab-head-and-neck-cancer-trial-stopped-earl. Accessed January 29, 2016.