FDA grants priority review to Imfinzi with chemotherapy for advanced biliary tract cancer
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The FDA granted priority review to durvalumab plus chemotherapy for treatment of locally advanced or metastatic biliary tract cancer.
Durvalumab (Imfinzi, AstraZeneca) — a PD-L1 checkpoint inhibitor — is approved in the United States for treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed after chemoradiotherapy. It also is approved for treatment of extensive-stage small cell lung cancer.
The FDA based priority review of the biliary tract cancer indication on results of the randomized phase 3 TOPAZ-1 trial.
The international, double-blind trial included 685 patients previously untreated for unresectable locally advanced, recurrent or metastatic biliary tract cancer.
Researchers randomly assigned the patients 1:1 to gemcitabine and cisplatin with either 1,500 mg durvalumab every 3 weeks (n = 341; median age, 64 years; range, 20-84; 50.4% women) or placebo (n = 344; median age, 64 years; range, 31-85; 48.8% women).
Patients received 1,000 mg/m2 and 25 mg/m2 cisplatin on days 1 and 8 every 3 weeks for up to eight cycles, after which they continued to receive 1,500 mg durvalumab every 4 weeks or placebo until disease progression or unacceptable toxicity.
OS served as the primary objective; secondary endpoints included PFS, objective response rate and safety.
As Healio previously reported, results presented at ASCO Gastrointestinal Cancers Symposium showed durvalumab plus chemotherapy conferred a statistically significant improvement in OS (median, 12.8 months vs. 11.5 months; HR = 0.8; 95% CI, 0.66–0.97) and PFS (median, 7.2 months vs. 5.7 months; HR = 0.75; 95% CI, 0.64–0.89) compared with placebo and chemotherapy.
The durvalumab group also had a higher rate of 2-year OS (24.9% vs. 10.4%) and a higher ORR (26.7% vs. 18.7%), and lower rates of grade 3 to grade 4 treatment-related adverse events (62.7% vs. 64.9%) and adverse events that led to discontinuation of any study medication (8.9% vs. 11.4%).
The FDA is expected to make a decision on approval for this indication in the third quarter of this year.
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