Bristol Myers Squibb (BMS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab).
This combination is indicated for the first-line treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).
The positive opinion is based on results from the CheckMate -8HW trial, presented at medical congresses earlier this year.
These findings supported Bristol Myers Squibb’s Type II variation application, which was validated by the EMA.
In the trial, Opdivo plus Yervoy showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy. The benefit was assessed by Blinded Independent Central Review.
It showed a 79% reduction in the risk of disease progression or death compared to chemotherapy.
Along with a reduced risk of disease progression or death, the safety profile of the dual immunotherapy combination was consistent with previous data.
No new safety concerns were identified, and the treatment was manageable using established protocols.
The European Commission (EC) will now review the recommendation and decide on approval.
Bristol Myers Squibb gastrointestinal and genitourinary cancers global programme lead vice president Dana Walker said: “Approximately 5-7% 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.”
Last month, 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.
The study is ongoing, with additional secondary endpoints, including overall survival (OS), still being assessed.
In the same month, the company received approval from the US Food and Drug Administration (FDA) for Opdivo to treat adults with lung cancer.
In a similar development, the biopharmaceutical firm received positive CHMP opinion for repotrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC) and advanced NTRK-positive solid tumours.
The recommendation is based on data from the registrational TRIDENT-1 and CARE trials, which showed robust responses and durable activity with repotrectinib in these patient populations.
The final EC decision is expected in January next year.
