On April 27, 2026 AstraZeneca (NYSE: AZN) reported that the China National Medical Products Administration has officially approved Imfinzi (Imfinzi,Durvalumab in combination with ImjudoTrimelimab is used as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In addition,Durvalumab has also been approved as monotherapy for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In early April, this combination regimen was approved in China, along with platinum-based chemotherapy, for first-line treatment of metastatic non-small cell lung cancer (NSCLC) that is negative for epidermal growth factor receptor (EGFR) sensitive mutations and anaplastic lymphoma kinase (ALK).
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This approval is based on the results of the global Phase III clinical trial HIMALAYA and the Chinese cohort. Global cohort data shows that, compared to…Compared with sorafenib monotherapy , the STRIDE regimen significantly reduced the risk of death by 22% in patients (hazard ratio [HR] 0.78; 95% confidence interval [CI], 0.66–0.92; p = 0.0035). (Single dose)Trimerumab combined with fixed intervalThe median overall survival (OS) in the durvalumab (STRIDE) combination therapy group was 16.4 months, whileThe sorafenib group had a duration of 13.8 months.durvalumab monotherapy compared toSorafenib demonstrated a non-inferiority benefit in overall survival (OS) (HR 0.86; 95% CI, 0.73–1.02), with a pre-specified non-inferiority margin of 1.08 (based on the upper limit of 95.67% CI).The median overall survival (OS) in the durvalumab monotherapy group was 16.6 months.
The HIMALAYA study’s Chinese cohort analysis showed a clear long-term benefit trend for the STRIDE regimen, consistent with the global benefit trend. The median overall survival (OS) in the STRIDE combination therapy group was 25.3 months, compared to…In the sorafenib group (median OS of 14.1 months), the survival time was extended by more than 11 months, with a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.42-0.84), and the 3-year OS rate reached 40.6%, approximately [missing data].Twice that of the sorafenib control group. In terms of safety, the STRIDE regimen is comparable to…Durvalumab monotherapy demonstrated good safety and tolerability in both groups. Data showed that the STRIDE regimen group and…The incidence of grade 3 or higher treatment-related adverse events (TRAE) in the durvalumab monotherapy group was 24.1% and 12.4%, respectively, both lower than that in the control group.40.2% in the Sorafenib group.
(Press release, AstraZeneca, APR 27, 2026, View Source;utm_source=official [SID1234665019])