AstraZeneca Announces Phase III CALLA Trial of Imfinzi with Chemoradiotherapy Fails to Meet Primary Endpoint in Locally Advanced Cervical Cancer

On March 24, AstraZeneca announced that the Phase III CALLA study of PD-L1 inhibitor Imfinzi (durvalumab) combined with chemoradiotherapy (CRT) for locally advanced cervical cancer did not meet the primary endpoint of improving progression-free survival (PFS). Compared with CRT alone, PFS did not achieve a statistically significant improvement.

The safety and tolerability between the two groups in this trial were consistent, with no new unexpected safety findings observed. The data will be presented at an upcoming medical conference.

CALLA Study is a randomized, multicenter, double-blind, global Phase III clinical trial. A total of 770 patients with locally advanced cervical cancer received standard chemoradiotherapy (CRT) combined with a fixed dose of 1500 mg Imfinzi or placebo. Participants were treated once every four weeks for 24 cycles or until disease progression.

The trial was conducted at 120 centers across 15 countries, including the United States, Europe, Latin America, Africa, and Asia. The primary endpoint was progression-free survival (PFS), with key secondary endpoints including overall survival, safety, and tolerability.

Cervical cancer is the eighth most common and ninth most fatal cancer globally, with approximately 600,000 new cases diagnosed each year. About 40-50% of cervical cancer patients are diagnosed at a locally advanced stage. According to the current standard treatment of platinum-based chemotherapy combined with radiotherapy, the recurrence rate for locally advanced cervical cancer patients is approximately 40%, with a 5-year survival rate of about 65-70%. Over the past two decades, the standard treatment for these patients has not changed.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said: "The CALLA study evaluated a novel immunotherapy in locally advanced cervical cancer. While the results were not what we had hoped for, insights from the trial will advance our understanding and application of immunotherapy, exploring the benefits of Imfinzi across many tumor types within our broad clinical development program."