The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This recommendation marks a significant advancement in the treatment landscape for this subset of colorectal cancer patients, where current options often provide insufficient benefit.
The positive opinion is rooted in the results of the CheckMate -8HW trial, which were presented at medical congresses earlier this year. The data supported Bristol Myers Squibb’s (BMS) Type II variation application, validated by the EMA. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with the Opdivo plus Yervoy combination compared to chemotherapy, as assessed by Blinded Independent Central Review.
Significant Reduction in Disease Progression Risk
The CheckMate -8HW trial revealed a 79% reduction in the risk of disease progression or death compared to chemotherapy. The safety profile of the dual immunotherapy combination was consistent with previous data, with no new safety concerns identified. The treatment was manageable using established protocols.
Impact on MSI-H/dMMR mCRC Patients
Approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors. Dana Walker, vice president, global programme lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb, emphasized that this is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, offering a transformative benefit for MSI-H/dMMR patients in this population.
The European Commission (EC) will now review the CHMP recommendation and decide on final approval. The final EC decision is expected in January next year.
Ongoing Research and Other Approvals
In addition to this development, BMS announced that Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Opdivo monotherapy across all lines of therapy. This study is ongoing, with additional secondary endpoints, including overall survival (OS), still being assessed. Furthermore, the company recently received FDA approval for Opdivo to treat adults with lung cancer.
BMS also received a positive CHMP opinion for repotrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC) and advanced NTRK-positive solid tumors, based on data from the TRIDENT-1 and CARE trials.
