Bristol Myers Squibb has announced that the European Medicines Agency (EMA) will begin a review of its application covering the Opdivo (nivolumab)/Yervoy (ipilimumab) combination’s use in patients with advanced liver cancer.
As per the 19 July press announcement, the Type II variation application covers the combination medicine’s use as a first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not previously undergone systemic therapy. The application is supported by data from the Phase III CheckMate-9DW study (NCT04039607).
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Last month, BMS presented CheckMate-9DW clinical data at the 2024 American Society of Clinical Oncology (ASCO) Congress. In the study, treatment with the Opdivo/Yervoy combination resulted in a median overall survival (OS) benefit of 3.1 months over first-line oral multikinase inhibitors (TKIs)—exhibiting an OS of 23.7 months versus 20.6 months. The median follow-up duration was 35.2 months. The overall response rate (ORR) was 36%, and the combination demonstrated an OS rate of 49% and 38% at 24 and 36 months, respectively.
According to GlobalData Healthcare analysts, while positive data bolsters the chances of BMS’s combination therapy being used as a first-line HCC therapy, early OS data, and elements of the exclusion criteria make it difficult to determine if the treatment would be preferred by physicians. However, analysts commented that the trial design was “a step up” compared to those adopted by competitors in this space because BMS chose comparator drugs like Eisai’s Lenvima (lenvatinib) and Bayer’s Nexavar (sorafenib), which reflect a “more contemporary” standard of care.
Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, is approved to treat a variety of cancers, including renal cell carcinoma, gastric cancer, B cell Hodgkin lymphoma and urothelial carcinoma. Yervoy, a cytotoxic T-lymphocyte associated protein 4 (CTLA-4)-inhibiting monoclonal antibody, is approved as a monotherapy for the treatment of unresectable or metastatic melanoma. The Opdivo/Yervoy combination has been approved for several oncology indications such as renal cell carcinoma, metastatic colorectal cancer, and malignant mesothelioma. Still, the combination treatment missed the mark recently in a Phase III non-small cell lung cancer (NSCLC) study (NCT04026412).
According to GlobalData’s consensus forecasts, Opdivo is anticipated to generate total sales of $13bn in 2028. BMS continues to capitalize on Yervoy, which brought in global sales of $2.2bn in 2023. GlobalData is the parent company of Pharmaceutical Technology.
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