The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a combination therapy consisting of Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with colorectal cancer.

The recommendation is specifically for those with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

The European Commission (EC) will review the CHMP's recommendation before making a final decision on approval for the European Union (EU).

The CHMP's positive opinion is grounded in the outcomes from the Phase III, open-label CheckMate -8HW trial, which demonstrated a significant 79% decrease in disease progression or mortality risk compared to chemotherapy.

The randomised trial evaluated the efficacy of Opdivo in combination with Yervoy against Opdivo alone or the investigator's choice of chemotherapy.

839 patients were randomised to receive either Opdivo monotherapy, combination therapy or chemotherapy.

The combination therapy significantly improved progression-free survival (PFS), meeting the dual primary endpoint compared to chemotherapy, as assessed by blinded independent central review (BICR).

The safety profile for the dual immunotherapy combination was in line with previous data without any new safety concerns.

The ongoing CheckMate -8HW study will assess secondary endpoints, including overall survival.

Further data from October 2024 indicated that the combination therapy also significantly improved PFS compared to Opdivo monotherapy across all lines of therapy.

Bristol Myers Squibb gastrointestinal and genitourinary cancers global programme lead and vice-president Dana Walker stated: “Approximately 5 to 7% of metastatic colorectal cancer patients have dMMR or MSI-H tumours, and current treatment options often do not provide sufficient benefit.

“This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients in this population.

"We are focused on bringing Opdivo plus Yervoy to these patients in the European Union and look forward to the EC’s upcoming decision.”

In the same month, the company received approval from the US Food and Drug Administration for Opdivo to treat adults with resectable non-small cell lung cancer.