Durvalumab/Tremelimumab Approved in Japan for Advanced NSCLC and Select Unresectable GI Cancers


The decision to approve durvalumab plus tremelimumab in Japan for patients with advanced non–small cell lung cancer and unresectable biliary tract cancer and liver cancer was based on data from several phase 3 studies.

The Japanese Ministry of Health, Labour, and Welfare has approved durvalumab (Imfinzi) and tremelimumab (Imjudo) as treatments for patients with unresectable, advanced or recurrent non­–small cell lung cancer (NSCLC) and unresectable hepatocellular carcinoma (HCC), according to a press release from AstraZeneca. Additionally, single-agent durvalumab was approved for unresectable HCC and in combination with gemcitabine and cisplatin as a curative treatment for those with unresectable biliary tract cancer.1

Each indication was based on notable survival findings from several phase 3 studies, including the POSEIDON study (NCT03164616)—assessing durvalumab plus or minus tremelimumab in first-line metastatic NSCLC—the TOPAZ-1 study (NCT03875235)—of durvalumab plus chemotherapy in advanced biliary tract cancer—and the HIMALAYA study (NCT03298451)—analyzing durvalumab and tremelimumab in first-line advanced HCC.2-4

“Japan has one of the highest rates of diagnosis for liver and biliary tract cancers in the world, and lung cancer remains the country’s leading cause of cancer death. With these approvals for Imfinzi and Imjudo, patients in Japan can now be treated with novel immunotherapy-based treatment regimens that have demonstrated significant survival benefits across 3 complex cancers with poor prognoses,” Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, said in the press release.

Of note, tremelimumab and durvalumab were approved by the FDA for unresectable HCC in October 2022 and for metastatic NSCLC in November 2022.5,6


  1. Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers. News release. AstraZeneca. December 28, 2022. Accessed January 3, 2023. https://bit.ly/3VIw5w3
  2. Johnson ML, Cho BC, Luft A, et al. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non–small-cell lung cancer: the phase III POSEIDON study. J Clin Oncol. Published online November 3, 2022. doi:10.1200/JCO.22.00975
  3. Oh DY, He AR, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. N Engl J Med Evi. 2022;1(8): doi:10.1056/EVIDoa2200015.
  4. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. N Engl J Med Evi. 2022;1(8). doi:10.1056/EVIDoa2100070
  5. Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. News Release. AstraZeneca. October 24, 2022. Accessed January 3, 2023. https://bit.ly/3Fbwx1w
  6. FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. FDA. November 10, 2022. Accessed January 3, 2023. https://bit.ly/3Us5sf8
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