On October 25, 2021, AstraZeneca announced high-level positive results from the phase 3 clinical trial TOPAZ-1, demonstrating that adding the immunotherapy durvalumab (Imfinzi) to first-line standard-of-care chemotherapy leads to a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone in patients with advanced biliary tract cancer.
At a predefined interim analysis, an independent data monitoring committee concluded that the study met its primary end point of OS improvement in patients who received durvalumab plus chemotherapy versus chemotherapy alone. This combination also demonstrated an improvement in progression-free survival and overall response rate, key secondary end points.
Furthermore, the immunotherapy plus chemotherapy regimen was well-tolerated, had a safety profile similar to that of chemotherapy alone, and did not increase the discontinuation rate because of adverse events compared with chemotherapy alone.
“We are delighted TOPAZ-1 has been unblinded early due to clear evidence of efficacy for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile….We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, in a statement.
This is the first global, randomized clinical trial to demonstrate superior outcomes with immunotherapy plus chemotherapy over the current standard of care of chemotherapy alone in patients with advanced biliary tract cancer. The full data set will be presented at a forthcoming medical meeting and shared with the FDA.
In December 2020, the FDA granted durvalumab an orphan drug designation for the treatment of patients with biliary tract cancer.
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