Update on CALLA phase III trial of concurrent use of Imfinzi and chemoradiotherapy in locally advanced cervical cancer.-AstraZeneca
The CALLA Phase III trial for AstraZeneca’s Imfinzi (durvalumab) given concurrently with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of improving progression-free survival (PFS) versus CRT alone in the treatment of patients with locally advanced cervical cancer.
The safety and tolerability in this trial were consistent between the two arms and no new unexpected safety findings were observed. The data will be presented at a forthcoming medical meeting.
CALLA is a randomised, multi-centre, double-blind, global Phase III trial in which 770 patients with locally advanced cervical cancer were treated with standard-of-care CRT in combination with either a 1,500mg fixed dose of Imfinzi or placebo every four weeks for up to 24 cycles or until disease progression. The trial was conducted at 120 centres across 15 countries including in the US, Europe, Latin America, Africa and Asia. The primary endpoint was PFS and key secondary endpoints included overall survival and safety and tolerability.
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