The U.S. Food and Drug Administration has approved the immunotherapy Opdivo (nivolumab) as a treatment for two colorectal cancers that failed to respond to a chemotherapy combination, according to its developer, Bristol-Myers Squibb.
Opdivo becomes available to patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer whose disease progressed after a chemo regimen of fluoropyrimidine, Eloxatin (oxaliplatin), and Camptosar (irinotecan). The approval applies to adults and children older than 12.
“Patients with metastatic colorectal cancer who have dMMR or MSI-H tumors are less likely to respond to conventional chemotherapy,” Dr. Heinz-Josef Lenz, a gastrointestinal cancer expert at the University of Southern California, said in a press release. “While the challenges of treating these patients have been significant,” the tumors can respond to immune therapies, he said.
Advances in immunotherapy research are leading to new treatment options for patients with MSI-H metastatic colorectal cancer in particular, he added.
The FDA accelerated Opdivo’s approval after a Phase 2 clinical trial (NCT02060188) showing that it was effective against the cancers. The 74 patients in the CheckMate-142 study received Opvido every two weeks.
Twenty-eight percent of the 53 patients who had previously received fluoropyrimidine, Eloxatin, and Camptosar responded to Opdivo. This included one complete response and 14 partial responses.
Thirty-two percent of the entire patient population responded to Opdivo, with two complete responses and 22 partial responses. This suggested that it worked better in patients who had received chemotherapy before Opdivo.
Opdivo’s recommended dose is 240 milligrams administered intravenously over 60 minutes every two weeks — until the cancer progresses or patients experience unacceptable toxicity.
“As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,” said Chris Boerner, the president of Bristol-Myers Squibb’s U.S. Commercial operation. “This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”
“As the third most common type of cancer in the United States, our view is that colorectal cancer – particularly for those with dMMR or MSI-H metastatic disease – has been in need of new research and treatments,” said Michael Sapienza, chief executive officer of the Colon Cancer Alliance. “The approval of Opdivo for appropriate patients with this disease gives the community more hope.”