Bristol Myers Squibb (BMY) has announced positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for three of its therapies: Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for hepatocellular carcinoma (HCC) and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC), and Breyanzi (lisocabtagene maraleucel; liso-cel) for relapsed or refractory follicular lymphoma. These recommendations mark significant steps toward expanding treatment options for patients with these cancers in Europe. The European Commission (EC) will now review the CHMP's recommendations, with decisions expected within approximately two months.
Opdivo and Yervoy for Hepatocellular Carcinoma
The CHMP recommended approval of Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable or advanced HCC. This positive opinion was based on the results of the Phase 3 CheckMate -9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to investigator's choice of lenvatinib or sorafenib in patients with HCC. HCC is the most common type of liver cancer, representing a significant unmet medical need.
The FDA has also accepted Bristol Myers Squibb's supplemental biologics license application for this combination as a potential first-line treatment, with a target action date of April 21, 2025. The Opdivo and Yervoy combination was previously granted accelerated approval by the FDA in 2020 as a second-line treatment for advanced HCC, based on the Phase 2 CheckMate -040 trial.
Opdivo and Yervoy for Metastatic Colorectal Cancer
The CHMP also recommended 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). The CheckMate -8HW trial results showed a significant reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) compared to chemotherapy in this patient population.
According to Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb, approximately 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumours, and current treatment options often do not provide sufficient benefit. She stated that this combination 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.
The positive opinion is based on results from the CheckMate -8HW trial, in which Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the investigator’s choice of chemotherapy. The safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.
Breyanzi for Follicular Lymphoma
The CHMP recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more prior lines of systemic therapy. The recommendation was based on data from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date evaluating a CAR T-cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including follicular lymphoma.
Results from the TRANSCEND FL study showed a 97.1% response rate to Breyanzi, with 94.2% of patients achieving complete response. Breyanzi is already approved in the EU for other lymphoma indications, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma grade 3B (FL3B).
These positive CHMP opinions represent a significant advancement in treatment options for patients with HCC, mCRC and follicular lymphoma in Europe. The EC is expected to make its final decision on these recommendations within the next two months.
