(Cholangiocarcinoma, Hepatocellular Carcinoma, Lung Cancer) Imfinzi and Imjudo Approved by Japan's Ministry of Health, Labour and Welfare
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On December 23, 2022, AstraZeneca announced that anti-PD-L1 antibody Imfinzi (durvalumab) and anti-CTLA-4 antibody Imjudo (tremelimumab) received manufacturing and sales approval from Japan's Ministry of Health, Labour and Welfare. Imfinzi monotherapy is approved for unresectable cholangiocarcinoma and unresectable hepatocellular carcinoma, while Imfinzi + Imjudo combination therapy is approved for unresectable hepatocellular carcinoma and unresectable advanced/recurrent non-small cell lung cancer. These approvals are based on the following clinical trial results.
TOPAZ-1 Trial
Imfinzi monotherapy approval for unresectable cholangiocarcinoma is based on interim analysis results from the TOPAZ-1 Phase 3 clinical trial conducted by international facilities. The trial compared Imfinzi + gemcitabine + cisplatin versus placebo + gemcitabine + cisplatin as first-line treatment, verifying efficacy and safety. Cholangiocarcinoma patients included intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
HIMALAYA Trial
Imfinzi monotherapy and Imfinzi + Imjudo combination therapy approval for unresectable hepatocellular carcinoma is based on HIMALAYA Phase 3 clinical trial results. This trial randomized treatment-naive hepatocellular carcinoma patients ineligible for locoregional therapy and unresectable (N=1324) into Imfinzi monotherapy group, Imfinzi + Imjudo combination therapy group, and sorafenib group, evaluating overall survival, progression-free survival, objective response rate, and safety.
POSEIDON Trial
Imfinzi + Imjudo combination therapy approval for unresectable advanced/recurrent non-small cell lung cancer is based on POSEIDON Phase 3 clinical trial results conducted by international facilities. Stage IV metastatic non-small cell lung cancer patients (N=1013) were divided into Imfinzi + chemotherapy group, Imfinzi + Imjudo + chemotherapy group, and chemotherapy group, evaluating efficacy and safety. Trial results showed progression-free survival endpoints were achieved in both Imfinzi + chemotherapy and Imfinzi + Imjudo + chemotherapy groups, with overall survival efficacy analysis.
Source: https://www.astrazeneca.co.jp/content/az-jp/media/press-releases1/2022/2022122803.html
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