SAN FRANCISCO ― Adding the checkpoint inhibitor durvalumab (Imfinzi) to chemotherapy significantly improved overall survival in patients with advanced biliary tract cancer, as compared to chemotherapy alone, according to interim results from the TOPAZ-1 trial.
The risk of death for those taking durvalumab plus chemotherapy was 20% lower than for patients on chemotherapy alone. At 18 months, overall survival was 35.1% in the durvalumab group vs 25.6% for chemotherapy alone. By 2 years, overall survival was 24.9% vs 10.4%.
"TOPAZ-1 is the first phase 3 trial to show that adding immunotherapy to standard chemotherapy can increase survival in biliary tract cancer, and importantly, does so without inducing any new serious side effects," said lead author Do-Youn Oh, MD, PhD, professor in the Division of Medical Oncology at Seoul National University Hospital and Seoul National University College of Medicine, Korea.
"The study met its primary endpoint at a prespecified interim analysis, and durvalumab plus gemcitabine and cisplatin demonstrated statistically significant and clinically meaningful prolonged overall survival compared with placebo plus chemotherapy," she said.
"This is an effective first-line therapy and could become a new standard of care for patients with advanced biliary tract cancer," she added.
Oh presented the results here at the at the Gastrointestinal Cancers Symposium (GICS) 2022.
