The FDA has granted accelerated approval to nivolumab for use in adult and adolescent patients with MSI-H or dMMR metastatic colorectal cancer.
The US Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for use in adult and adolescent patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed after treatment with a fluoropyrimidine- , oxaliplatin- , and irinotecan-containing regimen.
The approval was based on data from the CheckMate 142 clinical trial, which enrolled 53 patients with locally determined MSI-H or dMMR metastatic colorectal cancer who had progressed on prior therapy. Patients were assigned to nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity.
Twenty-eight percent of patients had an objective response to treatment. There was 1 complete response and 14 partial responses.
An FDA press release noted that nivolumab has not been studied in pediatric patients. Efficacy for adolescent patients-those age 12 years or older-with MSI-H or dMMR metastatic disease is extrapolated from results in the adult population.
Results of the CheckMate 142 study were presented at the 2017 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January. Commenting on the presented results, Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, said, “Nivolumab monotherapy provided durable responses, disease control, and long-term survival in patients with MSI-H metastatic colorectal cancer. Responses were observed regardless of tumor or immune cell PD-L1 expression, regardless of BRAF or KRAS mutation status, and regardless of clinical history of Lynch syndrome.”
The most common adverse events with nivolumab were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia.
The drug was approved at a recommended dose of 240 mg as an intravenous infusion over 60 minutes every 2 weeks.
Another immunotherapy, pembrolizumab, was approved for a similar indication in May.