FDA Approves Durvalumab for Biliary Tract Cancer

The US Food and Drug Administration (FDA) has approved durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC).

In the TOPAZ-1 randomized, double-blind, placebo-controlled, multiregional trial, 685 patients with histologically confirmed locally advanced unresectable or metastatic BTC were randomized to a combination of durvalumab with gemcitabine and cisplatin or placebo with gemcitabine and cisplatin.

The major efficacy outcome measure was overall survival (OS). The investigators conducted tumor assessments every 6 weeks for the first 24 weeks, and then every 8 weeks until confirmed objective disease progression. A statistically significant improvement in OS was demonstrated among patients randomized to receive the combination containing durvalumab.

Among 685 patients with histologically confirmed locally advanced unresectable or metastatic BTC, “the median OS was 12.8 months (95% CI: 11.1, 14) and 11.5 months (95% CI: 10.1, 12.5) in the durvalumab and placebo arms, respectively (hazard ratio 0.80; 95% CI: 0.66, 0.97, p=0.021). The median progression-free survival was 7.2 months (95% CI: 6.7, 7.4) and 5.7 months (95% CI: 5.6, 6.7) in the durvalumab and placebo arms, respectively,” the FDA stated in its announcement. “Investigator-assessed overall response rate was 27% (95% CI: 22% - 32%) and 19% (95% CI: 15%-23%) in the durvalumab and placebo arms, respectively.”

The most common adverse reactions among patients in the trial were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.

—Rebecca Mashaw

Reference:

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer. News release. US Food and Drug Administration; September 2, 2022. Accessed September 6, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-locally-advanced-or-metastatic-biliary-tract-cancer