AstraZeneca’s Phase 3 Study on HER2-expressing Biliary Tract Cancer: A Potential Game Changer

AstraZeneca ((AZN)) announced an update on their ongoing clinical study.

AstraZeneca has launched the DESTINY-Biliary Tract Cancer-01 study, officially titled ‘A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer.’ The study aims to evaluate the efficacy and safety of T-DXd with rilvegostomig or as a monotherapy against the standard treatment in patients with advanced HER2-expressing biliary tract cancer (BTC), a significant area of unmet medical need.

The interventions being tested include Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig, both experimental therapies administered via intravenous infusion. These are compared to the standard-of-care regimen of Gemcitabine, Cisplatin, and Durvalumab, which are also administered intravenously.

This is a Phase 3, randomized, open-label study designed to assess treatment efficacy. The study employs a parallel intervention model without masking, meaning all participants and researchers know which treatment is being administered. The primary purpose is to determine the best treatment approach for HER2-expressing BTC.

The study began on May 21, 2024, with the primary completion date yet to be announced. The most recent update was submitted on August 18, 2025, indicating ongoing recruitment and progress.

This clinical update could positively influence AstraZeneca’s stock performance and investor sentiment, given the potential for T-DXd and Rilvegostomig to address a critical gap in BTC treatment. The study’s outcome could also impact competitors in the oncology market, particularly those focusing on HER2-expressing cancers.

The study is currently ongoing, with further details available on the ClinicalTrials portal.