AstraZeneca did not achieve statistical significance in its CALLA Phase III study for locally advanced cervical cancer using Imfinzi with chemoradiotherapy.
The advancement of progression-free survival (PFS) for patients with locally advanced cervical cancer through the CALLA Phase III study for Imfinzi (durvalumab) assisted by chemoradiotherapy failed to achieve statistical significance compared to administering chemoradiotherapy alone.
The trial’s safety and tolerability were consistent in both arms, and no new unexpected adverse findings were discovered.
Bradley Monk, MD, 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.”
Cervical cancer is diagnosed in appoximately 600,000 people each year with 40-50% patients facing locally advanced cervical cancer.
CALLA is a worldwide Phase III trial, in which 770 patients with locally advanced cervical cancer were administered basic chemotherapy with either a 1,500mg fixed dosage of Imfinzi or a placebo every four weeks for up to 24 cycles, or until disease progression.
The trial took place across 120 locations in 15 countries, including the United States, Europe, Latin America, Africa, and Asia.
The primary goal was PFS, with overall survival, safety and tolerability as significant secondary outcomes.
Imfinzi (durvalumab) is a human monoclonal antibody that disrupts the interaction of PD-L1 with the PD-1 and CD80 proteins, preventing the tumour from evading the immune system.
Based on the PACIFIC Phase III trial, Imfinzi is the only immunotherapy approved for the curative-intent treatment of unresectable, Stage III non-small cell lung cancer in patients whose illness has not progressed after chemoradiotherapy.
Imfinzi has shown clinical efficacy in various cancer cases in the last year, including advanced biliary tract cancer (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA), and metastatic NSCLC, including favourable Phase III trials (POSEIDON).
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.”
AstraZeneca shares gained 0.5% to 9,781 following the announcement of its CALLA Phase III study not achieving statistical significance.