ASCO24: Opdivo, Yervoy duo shows 21% OS benefit in first-line liver cancer
04 Jun 2024
Clinical ResultPhase 3ASCOImmunotherapyDrug Approval
Bristol Myers Squibb's immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) significantly extended overall survival (OS), reducing the risk of death by 21% compared to Eisai's Lenvima (lenvatinib) or Bayer's Nexavar (sorafenib) in previously untreated patients with unresectable hepatocellular carcinoma (HCC).
Details of the Phase III CheckMate -9DW trial toplined in March were presented Tuesday on the final day of the American Society of Clinical Oncology (ASCO) annual meeting.
The results position BMS's PD-1/CTLA-4 duo as a potential new frontline alternative for advanced HCC, joining fellow immunotherapy regimens from Roche and AstraZeneca. Roche's combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) is an approved first-line treatment based on results showing it cut the risk of death by 42% compared to Nexavar, while AstraZeneca's duo of Imfinzi (durvalumab) plus Imjudo (tremelimumab) was cleared after showing a reduced mortality risk of 22% against Bayer's drug.
OS benefit of 3.1 months
According to CheckMate -9DW data presented at ASCO, the combination led to a median OS improvement of 3.1 months in first-line patients compared to investigator's choice of either single-agent Lenvima or Nexavar. Those receiving the immunotherapy duo survived a median 23.7 months, compared with 20.6 months for the comparator arm. BMS noted that survival benefit was generally consistent across patient subgroups.
More than double ORR
Opdivo-Yervoy also demonstrated superior efficacy on key secondary endpoints, including a 36% objective response rate (ORR), versus 13% for either Lenvima or Nexavar.
Moreover, the combination yielded a higher complete response (CR) rate of 7%, compared to 2% for the tyrosine kinase inhibitor (TKI) group. Among responders, the median duration of response was 30.4 months for Opdivo-Yervoy versus 12.9 months for Lenvima or Nexavar. It also reduced the risk of symptom deterioration by 24% compared to the two TKIs.
The combo's safety profile remained consistent with previously reported data. Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients receiving the immunotherapy regimen and 91% in the TKI group. Grade 3/4 TRAEs occurred in 41% and 42% of patients, respectively.
"The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC," said Dana Walker, global me lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb. "With these results, we can demonstrate that Opdivo plus Yervoy significantly increases survival and other key efficacy measures in the first-line setting." She said the company would be discussing the CheckMate -9DW data with regulators for a potential label expansion.
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