In April 2021, the FDA approved the immunotherapy Opdivo (nivolumab; from Bristol Myers Squibb), a PD-1 monoclonal antibody, for use with chemotherapy, as first-line treatment for patients with advanced or metastatic gastric cancer, including gastroesophageal junction cancer and esophageal adenocarcinoma.
Opdivo is the first immunotherapy, and the first PD-1 inhibitor, to receive FDA approval for use as the first treatment for these gastric cancers. It has been previously approved by the FDA for many types of cancer, but not for gastric cancer.
“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.”
About 28,000 new patients are diagnosed with gastric cancer each year in the United States. With the current therapies available for these patients, the survival rate is generally poor. The rate of cure by surgery is very low, and the survival rate for patients with any disease stage is 32%. Only 5% of patients with advanced or metastatic gastric cancer survive 5 years.
The effectiveness of treatment with Opdivo in gastric cancer was demonstrated in a clinical trial with 1,581 patients who had not received previous therapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
Patients were divided into 2 groups—789 patients received Opdivo plus chemotherapy and 792 patients received chemotherapy alone. On average, those who received Opdivo plus chemotherapy lived 2.2 months longer than those who received chemotherapy alone. The average survival was 13.8 months with Opdivo plus chemotherapy versus 11.6 months with chemotherapy alone.
The most common side effects of Opdivo plus chemotherapy include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain. Like all immunotherapies, Opdivo can cause serious side effects related to inflammation of healthy organs, including the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis).
