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Phase 3 trial shows Opdivo improves OS in patients with gastric cancer
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The phase 3 ONO-4538-12 trial designed to evaluate nivolumab in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of OS, according to the drug’s manufacturer.
In the multicenter, double blind clinical trial, researchers randomly assigned patients with advanced gastric cancer to receive 3 mg of nivolumab (Opdivo, Bristol-Myers Squibb) or placebo every 2 weeks until disease progression or discontinuation due to unacceptable toxicity.
“Patients with advanced or recurrent gastric cancer generally have a poor prognosis, and there are currently no standard-of-care treatment options for patients who fail to respond to or who are intolerant of standard chemotherapy,” Fouad Namouni, MD, head of development of oncology at Bristol-Myers Squibb, said in a press release. “With the results from the ONO-4538-12 study, nivolumab is now the first immuno-oncology agent to demonstrate a survival benefit for this patient population.”
Nivolumab is indicated as a single agent for the treatment of patients with BRAF V600 wild-type and mutation-positive unresectable or metastatic melanoma; in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma; for the treatment of patients with metastatic non–small cell lung cancer with progression on or after platinum-based chemotherapy; and for the treatment of patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy.