BMS presented late-stage results on Tuesday at the ASCO annual meeting which showed the combination of Opdivo and Yervoy lowered the risk of death by 21% in patients with unresectable hepatocellular carcinoma, compared to two kinase inhibitors.
Bristol Myers Squibbs’ combination approach could become a first-line option for unresectable liver cancer based on Phase III Opdivo-Yervoy data shared Tuesday at the American Society of Clinical Oncology’s annual meeting.
In the CheckMate -9DW trial, the immunotherapy duo increased median overall survival by three months—23.7 months compared to 20.6 months for patients on Eisai’s Lenvima or Bayer’s Nexavar—in patients with unresectable hepatocellular carcinoma (HCC), a 21% improvement on risk of death. Objective response rate for those taking Opdivo plus Yervoy was 36% compared to 13% for those on the kinase inhibitors, with the median duration of response at 30.4 months and 12.9 months, respectively.
“The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC and, with these results, we can demonstrate that Opdivo plus Yervoy significantly increases survival and other key efficacy measures in the first-line setting for patients with advanced disease,” Dana Walker, vice president of BMS’ gastro cancer programs, said in a statement.
In terms of safety, the Opdivo-Yervoy combo was consistent with previously reported data and was manageable with established protocols, according to BMS. Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients treated with Opdivo-Yervoy and 91% in patients with Lenvima or Nexava. Grade 3/4 TRAEs occurred in 41% and 42% of patients, respectively.
Opdivo plus Yervoy is already approved as a first-line treatment in certain types of melanomas and non-small cell lung cancers.
If approved, the move positions BMS to compete with other combo treatments on the market for liver cancer. Roche’s Tecentriq plus Avastin and AstraZeneca’s Infinzi plus Imjudo both earned their approvals for first line indication based on results from Phase III trials that pitted them against Nexavar.
AstraZeneca’s anti-CTLA-4 antibody with its checkpoint inhibitor reduced the risk of death compared to Nexavar by 22%. Roche’s combination showed a 42% death risk reduction. A post hoc analysis revealed median overall survival for patients on Tecentriq plus Avastin at 19.2 months versus 13.4 months for Nexavar.
After three years, 38% of patients on BMS’ Opdivo and Yervoy compared to 24% on Nexavar in the CheckMate –9DW trial.
BMS said it will be discussing the Phase III data with global health authorities to bring the combination treatment to more patients.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
