(Cholangiocarcinoma, Hepatocellular Carcinoma, Lung Cancer) Imfinzi and Imjudo Approved by Japan's Ministry of Health, Labour and Welfare

(Cholangiocarcinoma, Hepatocellular Carcinoma, Lung Cancer) Imfinzi and Imjudo Approved by Japan's Ministry of Health, Labour and Welfare

(Cholangiocarcinoma, Hepatocellular Carcinoma, Lung Cancer) Imfinzi and Imjudo Approved by Japan's Ministry of Health, Labour and Welfare

• January 18, 2023
• Reading time 1 minute

On December 28, 2022, AstraZeneca announced on December 23 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

• Immunotherapy

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