Breakthrough status and promise of a speedy review arrives for Opdivo/Yervoy combination as Bristol-Myers bites at Bayer
Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.
The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.
The US regulator gave the nod based off a Phase I/II trial of 620 patients that was completed in January, and for which the final data will be collected in 2021. A 2019 analysis showed the combination produced response rates just above 30% in three different dosing arms, with one arm showing an overall survival of 22.8 months.
Just two months ago, the NJ-based pharma giant announced that Opdivo failed to beat Nexavar (Sorafenib), the standard of care, as a frontline treatment for advanced HCC. A victory there would have been a major advance, signaling the first major step forward in frontline advanced HCC treatment since Bayer introduced Nexavar 12 years ago.
Bristol-Myers will be competing with Bayer’s inhibitor Stivarga (regorafenib) and Eli Lilly’s VEGFR2 inhibitor Cyramza (ramucirumab) as it looks to capture the second-line market. Cyramza was approved for HCC in May.
Despite some bumps, liver cancer has proven a far smoother path than one of the other major solid tumor types Bristol-Myers has been working hard to get Opdivo approved for non-small cell lung cancer. A major setback in 2016 allowed Merck to take the lead, and Bristol-Myers has been struggling to catch up ever since.
Most recently, though, they touted Phase III data testing an Opdivo combination as a frontline therapy against advanced NSCLC. The results showed improved overall survival rate for patients who were given a combination of Opdivo and Yervoy alongside chemotherapy, although outside analysts raised concerns about toxicity.