CHMP to approve BMS' Opdivo for colorectal cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has put forward a recommendation for the approval of a combined therapy involving Bristol Myers Squibb’s (BMS) drugs Opdivo (nivolumab) and Yervoy (ipilimumab). This recommendation pertains to the first-line treatment of adult patients with colorectal cancer, specifically targeting those with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

The European Commission (EC) is slated to review this recommendation and will make a final decision regarding its approval for use within the European Union (EU). The CHMP’s favorable opinion is based on the results of the Phase III CheckMate -8HW trial, an open-label study that highlighted a 79% reduction in the risk of disease progression or mortality when compared to chemotherapy. This randomized trial compared the efficacy of Opdivo combined with Yervoy against Opdivo alone or the chosen chemotherapy of the investigators.

A total of 839 patients participated in the trial, with each of them being assigned to receive either the monotherapy of Opdivo, the combination therapy, or chemotherapy. The combination therapy showed a significant improvement in progression-free survival (PFS), meeting the dual primary endpoint as evaluated by a blinded independent central review (BICR). The safety profile of the dual immunotherapy combination was consistent with previous data, showing no new safety concerns.

The CheckMate -8HW study is ongoing and will continue to evaluate secondary endpoints, including overall survival. Data collected up to October 2024 indicated that the combination therapy also significantly improved PFS when compared to Opdivo monotherapy across all treatment lines.

Dana Walker, the lead for Bristol Myers Squibb’s global program on gastrointestinal and genitourinary cancers, commented on the findings. She noted that around 5 to 7% of patients with metastatic colorectal cancer have dMMR or MSI-H tumors, and current treatments often fail to provide adequate benefits. She emphasized that this represents the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, offering transformative benefits for patients with MSI-H/dMMR in this group. Walker expressed the company’s commitment to making Opdivo and Yervoy available to these patients in the EU and is looking forward to the EC’s decision.

Additionally, in the same month, Bristol Myers Squibb received approval from the US Food and Drug Administration (FDA) for Opdivo to be used in the treatment of adults with resectable non-small cell lung cancer.