Bristol-Myers' Opdivo/Yervoy sBLA for HCC Gets Priority Review

Bristol-Myers Squibb Company BMY announced that the FDA has accepted and granted priority review designation to a supplemental Biologics License Application (sBLA) for the label expansion of Opdivo (nivolumab) in combination with Yervoy. The sBLA is seeking to get the dual immuno-oncology therapy approved in patients with advanced hepatocellular carcinoma (“HCC”), previously treated with Bayer’s BAYRY chemotherapy, Nexavar (sorafenib). HCC is the most common type of liver cancer. The FDA is expected to give its decision on Mar 10, 2020.

The submission was based on data from the phase I/II CheckMate 040 study investigating Opdivo-Yervoy combo in advanced HCC patients after prior treatment with Nexavar. Data from the study presented at the 2019 American Society of Clinical Oncology ("ASCO") Annual Meeting showed that treatment with Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months.  Meaningful responses were observed across treatment arms.

We note that the FDA also granted Breakthrough Therapy Designation to this dual immuno-oncology therapy for previously-treated advanced HCC patients.

Shares of Bristol-Myers’ shares have increased 11.9% so far this year compared with the industry’s rise of 3.7%.

We note that Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries, including the United States, the EU and Japan, for several cancer indications.

Meanwhile, the company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the drug into additional indications would give the product access to a higher patient population and increase its commercial potential significantly.

In a major achievement, Bristol-Myers successfully completed a pivotal study evaluating Opdivo plus low-dose Yervoy in advanced non-small cell lung cancer patients in first-line setting in October. Although Opdivo is approved for treating lung cancer in second or later line setting, the drug is yet to receive approval in first-line lung cancer indication. Lung cancer is the most common form of cancer representing a significant market opportunity. Other immuno-oncology drugs namely Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq have competitive advantage over Opdivo as they are already approved for first-line lung cancer. We expect the success in this pivotal study to change the scenario for Opdivo going forward.

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