Bristol Myers Squibb's sBLA Accepted by FDA for First-Line Treatment of Advanced Liver Cancer
Thursday, August 22, 2024
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for the use of Opdivo® (nivolumab) combined with Yervoy® (ipilimumab) as a potential first-line treatment for adults with unresectable hepatocellular carcinoma (HCC).
Opdivo is a PD-1 immune checkpoint inhibitor designed to harness the body's immune system to restore its anti-tumour response. Opdivo has become a key treatment across multiple cancers by leveraging the immune system to fight cancer.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval worldwide in July 2014. It is now approved in over 65 countries, including the U.S., the European Union, Japan, and China.
Yervoy is a human monoclonal antibody that targets the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a negative regulator of T-cell activity. Yervoy binds to CTLA-4, blocking its interaction with ligands CD80/CD86, which enhances T-cell activation and proliferation, including tumour-infiltrating T-effector cells. Inhibiting CTLA-4 signalling can also reduce T-regulatory cell function, potentially increasing overall T-cell responsiveness and anti-tumour immune response.
This decision is based on results from the Phase 3 CheckMate -9DW trial, with the FDA setting a Prescription Drug User Fee Act (PDUFA) goal date of 21 April 2025.
CheckMate -9DW is a Phase 3 randomised, open-label trial that compared the Opdivo and Yervoy combination with lenvatinib or sorafenib monotherapy in patients with unresectable or advanced HCC who had not received prior systemic treatment.
Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the Phase 3 CheckMate -9DW trial.
The submission is based on the Phase 3 CheckMate -9DW study, which showed a significant improvement in overall survival (OS) with the Opdivo and Yervoy combination compared to lenvatinib or sorafenib, as chosen by the investigator.
Previously, this combination has been an established second-line treatment for advanced HCC, and the study supports its potential use as a first-line therapy.
Liver cancer is the third leading cause of cancer deaths globally, with hepatocellular carcinoma (HCC) being the most common type, accounting for 75%-85% of all liver cancers.
HCC is often diagnosed at an advanced stage, limiting treatment options and typically leading to poor outcomes.
HCC is the most prevalent form of liver cancer, often diagnosed at a stage where surgery is not viable. With HCC cases in the U.S. rising over the past decade, there is a pressing need for new treatments.
The company is eager to work with the FDA to potentially introduce a new first-line treatment for patients.
A total of 668 patients were randomised to receive either the combination of Opdivo (1 mg/kg) and Yervoy (3 mg/kg) every three weeks for up to four doses, followed by Opdivo monotherapy (480 mg) for a maximum of two years, or lenvatinib or sorafenib as oral capsules. The primary endpoint was overall survival, with key secondary endpoints including objective response rate and time to symptom deterioration.
Bristol Myers Squibb’s global development programme for Opdivo is supported by its scientific expertise in Immuno-Oncology and includes a wide range of clinical trials, including Phase 3 studies, across various tumour types. To date, more than 35,000 patients have been treated in Opdivo trials, helping to enhance understanding of biomarkers and how patients might benefit from Opdivo across different levels of PD-L1 expression.
Source:bms.com
