Z Gastroenterol 2025; 63(08): e548
DOI: 10.1055/s-0045-1810971
Abstracts | DGVS/DGAV
Kurzvorträge
Innovative diagnostische & therapeutische Optionen bei pankreatikobiliären Karzinomen Donnerstag, 18. September 2025, 14:15 – 15:43, Seminarraum 6 + 7

Safety of 30 min infusion of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in first-line treatment (tx) of advanced biliary tract cancer (aBTC): TOURMALINE early results

Authors

  • J Chater

    1   Klinikum Chemnitz, Chemnitz, Deutschland

  • D-Y Oh

    2   Seoul National University College of Medicine, Division of Medical Oncology, Seoul, Korea, Republik

  • M Ikeda

    3   National Cancer Center Hospital East, Department of Hepatobiliary and Pancreatic Oncology, Kashiwa, Japan

  • A R He

    4   Georgetown University, Division of Hematology and Oncology, Lombardi Comprehensive Cancer Center, Washington, DC, Vereinigte Staaten

  • T Macarulla

    5   Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spanien
    6   Vall d’Hebron University Hospital, Barcelona, Spanien

  • A Dane

    7   Danestat Consulting Limited, Statistics, Macclesfield, Vereinigtes Königreich

  • J O Park

    8   Sungkyunkwan University School of Medicine, Department of Medicine, Seoul, Korea, Republik

  • F Dayyani

    9   University of California Irvine, Division of Hematology/Oncology, Orange, Vereinigte Staaten

  • G Wetherill

    10   AstraZeneca, Oncology Biostatistics Unit, Cambridge, Vereinigtes Königreich

  • A Stell

    11   AstraZeneca, Global Medical Affairs, Cambridge, Vereinigtes Königreich

  • B Baur

    12   AstraZeneca, Global Medical Affairs, Gaithersburg, Vereinigte Staaten

  • P Sun

    12   AstraZeneca, Global Medical Affairs, Gaithersburg, Vereinigte Staaten

  • A Vogel

    13   Princess Margaret Cancer Centre, Toronto General Hospital, Toronto, Kanada
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Background: The global, single-arm, Phase 3b TOURMALINE study (NCT05771480) assesses the safety and efficacy of D+G-based chemotherapy as first-line tx in aBTC. Optimising care by reducing infusion time may benefit patients and physicians. Preliminary safety data, including 30 min infusion time with D are reported.

Methods: Participants (pts) received D 1500 mg (first infusion: 60 min; subsequent infusions: 30 min) with an investigator-selected G-based chemotherapy (D+G alone or in combination with oxaliplatin, carboplatin, cisplatin (cis), tegafur-gimeracil-oteracil (S-1), cis+S-1, or cis+nab-paclitaxel). D was administered every 3 weeks (Q3W) with a G-based chemotherapy Q3W (8 cycles of D) or Q4W with G+cis+S-1 Q2W (4 cycles of D). Data cut-off (DCO) for the predefined safety review was 27 March 2024.

Results: Overall, 62 pts could have received≥2 cycles of D by DCO. Over 90% of pts were Asian with a median age of 66 years; 23% had locally advanced disease, 61% had metastatic disease and 16% had both. At screening, 24% of pts had ECOG PS 2, reflecting pts with more severe disease versus the TOPAZ-1 study (NCT03875235). Safety was comparable between 60 and 30 min D infusion time. One pt had an infusion reaction adverse event (AE) at Cycle 4 following D+G+oxaliplatin (possibly related to oxaliplatin). AEs and serious AEs (SAEs) were reported in 98% and 29% of pts, respectively, and 87% and 6% of pts had an AE or SAE possibly related to any study tx, respectively (Table). Grade 3 or 4 AEs and SAEs were reported in 68% and 24% of pts, respectively. AEs led to a D dose delay in 26% of pts and discontinuation in 2% of pts. Immune-related AEs (imAEs) occurred in 29% of pts (Table). There were no AEs with an outcome of death.

Conclusions: No difference in infusion-related safety between 30 and 60 min infusion time was observed. No new safety signals were seen with the addition of D to other chemotherapy regimens beyond TOPAZ-1 regimens.

Previously presented at ESMO ASIA 2024, Abstract 133O, Do-Youn Oh et. al. – Reused with permission



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Artikel online veröffentlicht:
04. September 2025

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