Bristol Myers Squibb has obtained approval from the US Food and Drug Administration (FDA) to use the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment option for adults with unresectable or metastatic hepatocellular carcinoma (HCC).
The approval has been driven by the results of the Phase 3 CheckMate-9DW trial, which demonstrated a significant survival benefit over existing treatments, lenvatinib or sorafenib.
The CheckMate-9DW trial involved 668 participants who were assigned to receive either the Opdivo and Yervoy combination therapy or a monotherapy with lenvatinib or sorafenib.
Results showed that patients receiving the combined treatment experienced an overall survival of 23.7 months, compared to 20.6 months for those on alternate therapies.
The trial also recorded a three-year overall survival rate of 38% for the combination therapy, surpassing the 24% observed with lenvatinib or sorafenib monotherapies.
Furthermore, the objective response rate was reported at 36.1% for the combination treatment, significantly higher than the 13.2% for the comparator drugs.
Bristol Myers Squibb oncology commercialisation senior vice president Wendy Short Bartie said: “Bringing Opdivo plus Yervoy to patients with HCC in the first-line setting is a testament to our ongoing commitment to research and delivering important progress for people living with cancer.
“Today’s approval builds on the legacy of our dual immunotherapy and the value it has brought to patients for years.”
This FDA approval extends the use of Opdivo plus Yervoy from its prior accelerated approval in 2020 to full approval, now including first-line treatment based on updated clinical evidence.
Prior to this decision, Opdivo and Yervoy had been utilised as second-line treatments for advanced HCC patients who had previously undergone sorafenib therapy, according to earlier findings from the CheckMate-040 trial.
Last week, the FDA approved the combination of Opdivo and Yervoy for use as a first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The approval covers both adult and paediatric patients aged 12 and older.
The FDA’s decision was informed by results from the CheckMate-8HW trial, where it was demonstrated that the combination of Opdivo and Yervoy decreased the risk of disease progression or death by 79% when compared to chemotherapy in a first-line treatment context.
Additionally, the combination therapy showed a 38% reduction in this risk compared to Opdivo alone across all treatment stages.
