Bristol Myers Squibb's Dual Immunotherapy Opdivo (nivolumab) + Yervoy (ipilimumab) Receives FDA Approval for Hepatocellular Carcinoma Previously Treated with Sorafenib
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
FDA
U.S. Food and Drug Administration
On March 11 local time, Bristol-Myers Squibb (BMS) announced that the U.S. FDA had approved the PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 inhibitor Yervoy (ipilimumab) for the treatment of patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. The press release noted that Opdivo plus Yervoy is the first and only dual immunotherapy approved by the FDA for this patient population. This combination therapy has a potential synergistic mechanism of action.
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths worldwide. Statistics indicate that over 750,000 people are diagnosed with hepatocellular carcinoma globally each year, with the majority of cases occurring in Asia and nearly half in China. The primary causes of HCC are chronic hepatitis resulting from hepatitis B or C virus infection, as well as cirrhosis caused by alcohol consumption or non-alcoholic steatohepatitis.
Opdivo (nivolumab) and Yervoy (ipilimumab) are immune checkpoint inhibitors developed by Bristol-Myers Squibb Company. They enhance T cell-mediated anti-tumor immune responses by inhibiting the PD-1 and CTLA-4 immune checkpoint proteins, respectively. These agents have received FDA approval for the treatment of metastatic melanoma and other cancer types.
The FDA approval was based on the Phase 1/2 clinical study named CheckMate-040. In patients with hepatocellular carcinoma (HCC) who had previously received sorafenib treatment, after a minimum follow-up of 28 months, 33% (16/49; 95% CI: 20–48) of patients achieved an objective response, with 8% (4/49) achieving a complete response (CR). The duration of response (DOR) ranged from 4.6 to 30.5+ months, with 88% of responses lasting at least six months, 56% lasting at least 12 months, and 31% lasting at least 24 months.
“HCC is an aggressive disease that requires diverse treatment approaches,” said Anthony B. El-Khoueiry, MD, Principal Investigator, Associate Professor of Clinical Medicine, and Head of Phase 1 Clinical Trials at the Keck School of Medicine of USC and the Norris Comprehensive Cancer Center. “The overall response rate observed in the CheckMate-040 trial underscores the potential of this dual immunotherapy as a treatment option for patients.”
We congratulate the approval of Opdivo + Yervoy for a new indication, providing a new treatment option and bringing more hope to patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
References:
[1] U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib. Retrieved 2020-03-11, from https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-ye-0
Original Title: Express | FDA Approves Bristol-Myers Squibb’s Dual Immunotherapy Combination for the Treatment of Hepatocellular Carcinoma
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