Updated follow-up results from the phase 3 TOPAZ-1 study revealed that durvalumab in combination with chemotherapy can improve overall survival (OS) in patients with advanced cholangiocarcinoma (CCA).
The double-blind TOPAZ-1 trial, sponsored by AstraZeneca, began in April 2019 to investigate the efficacy of durvalumab in combination with gemcitabine and cisplatin chemotherapy in patients with first-line advanced CCA. The trial met its primary end point of OS in October 2021 during a planned interim analysis, in which the combination was shown to reduce the risk of death by 20% against chemotherapy alone.
The 3-year follow-up results showed the continued efficacy of durvalumab with chemotherapy. The combination reduced the risk of death by 26% against chemotherapy alone. Median OS of durvalumab with chemotherapy was 12.9 months versus 11.3 months for chemotherapy alone, and 14.6% of patients who received the combination remained alive at 3 years compared with 6.9% of those who received chemotherapy.
Treatment-related adverse effects occurred in 15.4% of patients who received durvalumab plus chemotherapy and 17.3% of those who received chemotherapy. The combination continues to be well tolerated, with no new safety signals observed during follow-up.
Upon release of the new follow-up data, Stacie Lindsey, chief executive officer of the Cholangiocarcinoma Foundation, said, “AstraZeneca’s longer survival data in advanced biliary tract cancer represent a meaningful milestone in that we are seeing 3-year survival data for the first time for these patients. The data spur hope that research will continue to improve outcomes for patients living with these challenging and rare cancers.”
The TOPAZ-1 study is set to be completed in March 2025.
© 2025 Mashup Media, LLC, a Formedics Property. All Rights Reserved.