Durvalumab Plus Chemo Receives FDA Approval in Locally Advanced/Metastatic Biliary Tract Cancer

The FDA has granted approval to a combination of durvalumab (Imfinzi) and gemcitabine in adult patients with locally advanced or metastatic biliary tract cancer, according to a press release from the FDA.

The combination was evaluated as part of the phase 3 TOPAZ-1 trial (NCT03875235), which included a total of 685 patients with histologically confirmed locally advanced unresectable or metastatic disease who have not previously received treatment with systemic therapy for advanced biliary tract cancer. The median overall survival in the durvalumab arm was 12.8 months (95% CI, 11.1-14.0) compared with 11.5 months (95% CI, 10.1-12.5) in the placebo arm (HR, 0.80; 95% CI, 0.66-0.97; P = .021). Moreover, 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 each respective arm. Additionally, the investigator-assessed overall response rate was 27% (95% CI, 22%-32%) in the durvalumab arm and 19% (95% CI, 15%-23%) in the placebo arm.

Durvalumab has a recommended dose of 1500 mg every 3 weeks for those with a weight of more than 30 kg when administered with gemcitabine and cisplatin with a 1500-mg subsequent dose every 4 weeks as a monotherapy until disease progression or unacceptable toxicity. Those who weigh less than 30 kg have a recommended dose of 20 mg/kg every 3 weeks with gemcitabine and cisplatin with a subsequent dose of 20 mg/lg every 4 weeks until progression or unacceptable toxicity.

Common adverse effects included fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia.

Reference

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer. News release. FDA. September 2, 2022. Accessed September 2, 2022. https://bit.ly/3edCUWt