The European Commission (EC) has approved Bristol Myers Squibb’s (BMS) Opdivo plus Yervoy immunotherapy regimen for the treatment of certain metastatic colorectal patients (mCRC), the company announced yesterday.
The EC has cleared Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) mCRC, after prior fluoropyrimidine-based combination chemotherapy.
The approval is based on the positive results from BMS’ Phase II CheckMate-142 trial. In this trial, Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) for MSI-H/dMMR mCRC patients who had received prior treatment with fluoropyridine, oxaliplatin and irinotecan.
Specifically, 64.7% of patients responded to treatment with Opdivo plus Yervoy, with 12.6% achieving a complete response. The median duration of response was not reached in the Opdivo plus Yervoy arm at minimum follow-up of 46.9 months.
“Metastatic colorectal cancer is an aggressive disease with a poor prognosis, leaving patients with a critical need for additional treatment options beyond standard chemotherapy,” said Ian Waxman, development lead, gastrointestinal cancers, BMS.
“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,” he added.
Previously, the US Food and Drug Administration (FDA) approved Opdivo plus Yervoy for the treatment of adult and paediatric patients aged 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with luoropyrimidine, oxaliplatin and irinotecan.