Bristol Myers Squibb's Opdivo, Yervoy combination gains FDA approval in hepatocellular carcinoma

Bristol Myers Squibb said Wednesday that the FDA granted accelerated approval to a filing for Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat patients with hepatocellular carcinoma (HCC) who have been previously treated with Bayer's Nexavar (sorafenib). The company noted that the combination of the PD-1 immune checkpoint inhibitor and the anti-CTLA-4 antibody is "the first and only dual immunotherapy approved in this setting."

According to Bristol Myers Squibb, approval of Opdivo plus Yervoy is based on data from a cohort of the ongoing Phase I/II CheckMate -040 trial, which has a total of 1097 participants with advanced HCC, with or without chronic viral hepatitis. The study also included patients who were PD-L1 expressors and non-expressors. According to Bristol Myers Squibb, 49 patients were treated with the combination of Opdivo plus Yervoy, with the major efficacy outcome being objective response rate (ORR), while duration of response was also assessed.

Results showed that after a minimum follow up of 28 months, 33% of patients responded to treatment with Opdivo and Yervoy, with 8% achieving a complete response and 24% having a partial response. Durations of response ranged from 4.6 months to over 30.5 months, with 88% lasting at least six months, 56% at least one year and 31% at least two years.

Lead investigator Anthony El-Khoueiry noted that "HCC is an aggressive disease in need of different treatment approaches," adding that these results from the CheckMate -040 trial "[underscore] the potential of this dual immunotherapy as a possible treatment option for patients."

In 2018, the FDA granted accelerated approval to Merck & Co.'s Keytruda (pembrolizumab) for the treatment of HCC in patients who previously received Nexavar. The decision was based on data from the KEYNOTE-224 study, which showed that Keytruda was associated with an ORR of 17%, while among responding patients, 89% and 56% had a duration of response of at least six months and 12 months, respectively.

Along with HCC, the combination of Opdivo and Yervoy is also approved for the treatment of patients with unresectable or metastatic melanoma, intermediate or poor risk, previously untreated advanced renal cell carcinoma and for adults and paediatric patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

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