BMS's Opdivo/Yervoy Combo Shows Survival Benefit in First-line Liver Cancer Treatment

Bristol-Myers Squibb (BMS) is poised for a potential return to the liver cancer treatment landscape as the FDA begins its review of the Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy. The regulatory decision, expected by April 21, 2024, could establish a new first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC).

The application is supported by compelling data from the CheckMate-9DW trial, which enrolled 668 patients and demonstrated significant clinical benefits. The immunotherapy combination achieved an impressive objective response rate of 36%, nearly triple the 13% observed with standard targeted therapies. More importantly, the median overall survival reached 23.7 months with the Opdivo/Yervoy combination, compared to 20.6 months for patients receiving either Nexavar (sorafenib) or Lenvima (lenvatinib).

Competitive Landscape and Clinical Significance

If approved, the Opdivo/Yervoy combination would enter a market currently dominated by other immunotherapy-based treatments. Notable competitors include Roche's Tecentriq (atezolizumab) plus bevacizumab, and AstraZeneca's Imfinzi (durvalumab) with Imjudo (tremelimumab). Significantly, the BMS combination is the only therapy thus far to demonstrate a meaningful improvement in overall survival in this setting.

"HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option," explains Dana Walker, BMS global programme lead for gastrointestinal and genitourinary cancers. "With the number of individuals diagnosed with HCC in the US increasing over the last decade, new treatment options are urgently needed."

Historical Context and Future Impact

The FDA review marks a potential comeback for Opdivo in liver cancer treatment. The drug was previously withdrawn from the market in 2021 as a second-line treatment following a failed confirmatory trial in patients previously treated with Nexavar. If approved, this new indication would not only provide an additional treatment option but also serve as a new confirmatory trial for BMS's earlier approval in relapsed/refractory HCC.

The rising prevalence of HCC adds urgency to the development of effective treatments. While viral hepatitis remains a primary cause, the increasing incidence of metabolic syndrome and non-alcoholic steatohepatitis (NASH) is expected to drive higher rates of liver cancer in the future. The potential approval of Opdivo/Yervoy could offer hope to this growing patient population, particularly given its demonstrated survival advantage over current standard therapies.