AstraZeneca shares the latest overall survival (OS) data for IMFINZI® in combination with IMJUDO®

AstraZeneca recently shared the latest overall survival (OS) data for IMFINZI® (durvalumab) in combination with IMJUDO®(tremelimumab-actl) for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).1,2 

Primary Analysis
The primary analysis demonstrated statistically significant improvement in the primary endpoint of OS vs sorafenib in the first-line (1L) treatment of uHCC1,2:

  • 22% reduction in risk of death with IMFINZI + IMJUDO vs sorafenib (HR=0.78 [95% CI, 0.66-0.92]; P=0.0035)*
  • 16.4-month median overall survival (mOS) (95% CI, 14.2-19.6) with IMFINZI + IMJUDO vs 13.8-month mOS (95% CI, 12.3-16.1) with sorafenib
  • Median duration of follow-up was 33.2 months (range: 31.7-34.5) for IMFINZI + IMJUDO and 32.2 months (range: 30.4-33.7) for sorafenib3

*The HR is based on the stratified Cox proportional hazards model. The P value is based on a stratified log-rank test and a Lan-DeMets alpha spending function with O’Brien-Fleming–type boundary and the actual number of events observed. The boundary for declaring statistical significance for IMFINZI + IMJUDO vs sorafenib was 0.0398. The median duration of follow-up was 33.2 months (range: 31.7-34.5) for IMFINZI + IMJUDO and 32.2 months (range: 30.4-33.7) for sorafenib. Data cutoff: August 27, 2021.1-3

Updated Exploratory Analysis
IMFINZI + IMJUDO is the only approved 1L immuno-oncology regimen with 4-year OS data from the HIMALAYA Phase III study in uHCC.1-8

  • 25% 4-year OS rate with IMFINZI + IMJUDO vs 15% 4-year OS rate with sorafenib4†
  • In the exploratory analysis, the median duration of follow-up was 49.1 months (range: 47.0-50.2) with IMFINZI + IMJUDO and 47.3 months (range: 45.1-49.2) with sorafenib4
  • Estimates of OS rates were calculated using the Kaplan-Meier technique. OS rates at 18, 24, 36, and 48 months were exploratory endpoints, and were not formally tested for statistical significance3,4

At the time of the 4-year analysis, mOS was 16.4 months (95% CI, 14.2-19.6) with IMFINZI + IMJUDO and 13.8 months (95% CI, 12.3-16.1) with sorafenib (HR=0.78 [95% CI, 0.67-0.92]). OS data maturity across the IMFINZI + IMJUDO and sorafenib arms was 78%. Data cutoff: January 23, 2023.4

CI=confidence interval; HR=hazard ratioP=probability value.

For additional information on the exploratory analysis, please click here to view the full Four-Year Overall Survival Update From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma presentation.


IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

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