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서울대학교 의과대학, 서울대학교병원

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J. Hepatol., Jul 06 2026, S0168-8278(26)02658-9 | https://doi.org/10.1016/j.jhep.2026.06.025 Durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer: primary results from the phase IIIb TOURMALINE study

Do-Youn Oh ¹, Masafumi Ikeda ², Teresa Macarulla ³, Aiwu Ruth He ⁴, Joon Oh Park ⁵, Masayuki Kitano ⁶, Guido Giordano ⁷, Kyu-pyo Kim ⁸, Thomas Wirth ⁹, David Tai ¹⁰, Mohamed Bouattour¹¹, Tiziana Pressiani ¹², Farshid Dayyani ¹³, Angela Lamarca ^14,15, Ugochinyere Emeribe ¹⁶, Susanne Radke¹⁷, Peng Sun¹⁷, Boris Baur¹⁷, Arndt Vogel ^18,19

¹Division of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, Republic of Korea
²Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan
³Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain
⁴Herbet Irving Comprehensive Cancer Center, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA
⁵Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
⁶Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
⁷Unit of Medical Oncology and Biomolecular Therapy, Policlinico Riuniti, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy
⁸Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
⁹Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany
¹⁰Division of Medical Oncology, National Cancer Centre Singapore, Singapore
¹¹AP-HP Hôpital Beaujon, Liver Cancer and Innovation Therapy Unit, Paris, France
¹²Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
¹³Division of Hematology/Oncology, Department of Medicine, UC Irvine Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, USA
¹⁴Department of Oncology – OncoHealth Institute, Fundación Jiménez Díaz University Hospital, Madrid, Spain
¹⁵Oncology R&D, AstraZeneca, Gaithersburg, MD, USA
¹⁶Global Medical Affairs, AstraZeneca, Gaithersburg, MD, USA
¹⁷Division of Gastroenterology and Hepatology, Toronto General Hospital, Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Ontario, Canada
¹⁸Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Hannover, Germany
¹⁹Department of Medical Oncology, The Christie NHS Foundation, Division of Cancer Sciences, University of Manchester, Manchester, UK

Corresponding author: Do-Youn Oh

Abstract

Background & aims: TOPAZ-1 (NCT03875235) demonstrated improved overall survival (OS) with durvalumab plus gemcitabine and cisplatin vs. placebo plus gemcitabine and cisplatin with manageable safety in advanced biliary tract cancer (aBTC). The phase IIIb TOURMALINE study (NCT05771480) is evaluating the safety and efficacy of first-line durvalumab plus seven gemcitabine-based chemotherapy regimens in a close-to-real-world aBTC population, including participants with poor prognosis.

Methods: Participants received 1500 mg IV durvalumab (first infusion: 60 minutes; subsequent infusions: 30 minutes) plus investigator's choice of one of seven gemcitabine-based chemotherapy regimens. The primary endpoint was incidence of Grade 3/4 adverse events (AEs) possibly related to treatment (PRAEs) within 6 months of first durvalumab dose. Secondary endpoints included progression-free survival (PFS), OS, objective response rate (ORR), and safety.

Results: As of 17 September 2025, 142 participants (median age 68.0 years) had follow-up ≥6 months and received ≥1 treatment dose; most had metastatic disease (72.5%). Participants received a median of 9 cycles of durvalumab; median (IQR) follow-up was 11.63 (6.87-17.25) months. Overall, 50.7% (95% confidence interval [CI] 42.19-59.19) of participants experienced Grade 3/4 PRAEs within 6 months of durvalumab initiation, with no serious AEs of special interest with an outcome of death. Median PFS was 7.39 months (95% CI 6.74-9.07); median OS was 13.50 months (95% CI 11.24-20.53); ORR was 33.1% (95% CI 25.44-41.48).

Conclusions: Safety profiles of durvalumab plus seven gemcitabine-based chemotherapy regimens were manageable, and shorter durvalumab infusion duration (30 minutes vs. 60 minutes) did not increase infusion-related reactions. Efficacy data are indicative of potential clinical activity across treatment arms. These findings demonstrate the feasibility of combining durvalumab with alternative gemcitabine-based regimens in a broad aBTC population.

Impact and implications: The choice of gemcitabine-based chemotherapy backbones for the treatment of advanced biliary tract cancer (aBTC) varies globally and their use in conjunction with immunotherapy has not been fully investigated. The TOURMALINE phase IIIb study demonstrated manageable safety and efficacy data showed potential clinical activity in a close-to-real-world population of participants with aBTC receiving durvalumab plus one of seven gemcitabine-based chemotherapy regimens. These findings point towards the feasibility of combining durvalumab with different gemcitabine-based chemotherapy regimens, even in participants with less favourable disease characteristics.

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