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.
Bradley Monk, MD, FACOG, FACS, Professor at the University of Arizona College of Medicine and principal investigator in the CALLA Phase III trial, said: "While today's results were not statistically significant, they underscore the need for further evaluation of novel therapeutic options and will inform future strategies to improve treatment for patients with locally advanced cervical cancer."
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "CALLA tested a novel immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress following available treatments. While the results were not what we hoped for, insights from the trial will advance our understanding and application of immunotherapy across our broad clinical development programme, exploring the benefits of Imfinzi in many tumour types."
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.
Notes
Locally advanced cervical cancer
Cervical cancer is the eighth most common, and ninth most deadly, cancer worldwide, with approximately 600,000 people diagnosed each year.1 Approximately 40-50% of cervical cancer cases are diagnosed in the locally advanced stage.2 Following current standard-of-care treatment, platinum-based chemotherapy with radiation therapy, patients with locally advanced cervical cancer face an approximately 40% chance of disease recurrence and a five-year survival rate of about 65-70%.2,3 The standard-of-care treatment for these patients has not changed in over two decades.4
CALLA
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.
