Patients with locally advanced cervical cancer did not see further benefit from the addition of concurrent durvalumab to chemoradiotherapy.
Adding concurrent durvalumab (Imfinzi) to chemoradiotherapy (CRT) did not result in a statistically significant improvement in progression-free survival (PFS) over CRT alone in a population of patients with locally advanced cervical cancer, according to a press release from AstraZeneca.
The findings came from the phase 3 CALLA trial (NCT03830866), which assessed the combination vs CRT alone in this patient population. Investigators reported that the safety profiles were consistent between both arms, with no unexpected safety findings. Data from the trial will be presented at an upcoming medical meeting.
“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,” principal investigator Bradley Monk, MD, FACOG, FACS, professor of Obstetrics and Gynecology at the University of Arizona College of Medicine, said in a press release.
The randomized, multi-center, double-blind, global study enrolled a total of 770 patients. The study took place at 120 centers across 15 countries in the United States, Europe, Latin America, Africa, and Asia. Treatment consisted of standard-of-care CRT plus 1500 mg of durvalumab or placebo every 4 weeks up to 24 cycles or until progressive disease.
The primary end point was PFS with key secondary end points including overall survival and safety.
The population included female patients who were 18 years or older with documented evidence of stage IB2/IIB node positive or FIGO IIIA/IVA any node cervical adenocarcinoma or squamous carcinoma. Additionally, patients could not have received previous chemotherapy or radiotherapy for their disease and needed a WHO/ECOG performance status of 0 or 1 with at least 1 unirradiated lesion.
Patients with small cell histology or mucinous adenocarcinoma, intent to undergo fertility-sparing therapy, or previous hysterectomy could not enroll. Additional exclusion criteria included evidence of metastatic disease, history of allogeneic organ transplant, active or previous autoimmune or inflammatory disorders, uncontrolled intercurrent illness, or history of another primary malignancy/active primary immunodeficiency.
“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,” Susan Galbraith, executive vice president of Oncology Research and Development at AstraZeneca, concluded.
Update on CALLA phase III trial of concurrent use of Imfinzi and chemoradiotherapy in locally advanced cervical cancer. News release. AstraZeneva. March 24, 2022. Accessed March 24, 2022. https://bit.ly/3ICkIiR