NEW YORK – The European Commission on Tuesday approved Bristol Myers Squibb's nivolumab (Opdivo) and ipilimumab (Yervoy) as a combination treatment for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-high) metastatic colorectal cancer who have been previously treated with fluoropyrimidine-based combination chemotherapy.
The approval is based on data from the Phase II CheckMate-142 trial. In that study, 64.7 percent of patients responded to the nivolumab-ipilimumab combination, with 12.6 percent reaching a complete response. At a minimum of 46 months of follow-up, the median duration of response was not reached. The safety profile of nivolumab and ipilimumab in this trial was consistent with previous studies.
The nivolumab-ipilimumab combination is also approved in Europe as a first-line treatment for metastatic non-small cell lung cancer with chemo and for advanced renal cell carcinoma.
"Metastatic colorectal cancer is an aggressive disease with a poor prognosis, leaving patients with a critical need for additional treatment options beyond standard chemotherapy," Ian Waxman, development lead for gastrointestinal cancers at BMS, said in a statement. "With this approval, patients in the EU with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer will now have the first dual immunotherapy treatment available to them, and we look forward to working with stakeholders to advance this rational combination."
In July 2018, the US Food and Drug Administration approved nivolumab-ipilimumab for this same indication based on earlier results from the CheckMate-142 trial. This month, the UK's National Institute for Health and Care Excellence also recommended approval for the dual immunotherapy in this setting.
In January, Merck's competing immunotherapy pembrolizumab (Keytruda) also received approval in the EU for dMMR or MSI-high metastatic colorectal cancer. However, pembrolizumab was approved as a first-line treatment for these patients, while the BMS approval requires previous treatment with chemo.