AstraZeneca cervical cancer treatment fails to meet endpoint in Phase III trial
pharmafile | March 24, 2022 | News story | Business Services |
AstraZeneca has shared that results from its Calla Phase III trial of Imfinzi for the treatment of locally advanced cervical cancer did not meet the primary endpoint of significantly improving progression-free survival when used with chemoradiotherapy, compared with chemoradiotherapy alone.
The Calla Phase III study tested progression-free survival of patients with the combination against chemoradiotherapy alone.
“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 program, exploring the benefits of Imfinzi in many tumour types,” said Susan Galbraith, AstraZeneca’s executive vice president, oncology research and development.
AstraZeneca shared that while the trial did not achieve statistical significance in its primary endpoint of improving survival when tested on patients with locally advanced cervical cancer, safety and tolerability were consistent, and no new unexpected safety findings were observed.
Imfinzi belongs to the immunotherapy class of treatments which work by boosting the body’s own defences to fight cancer, by utilising specific antibodies.
The trial, which was conducted on 770 patients, saw participants treated with standard chemoradiotherapy and either a fixed dose of Imfinzi or a placebo, every four weeks for up to 24 cycles, or until disease progression.
Imfinzi is an existing lung cancer therapy, and is currently under development and regulatory review for other cancer indications as well. These include tumours in the bladder.
The results present a significant setback for one of AstraZeneca’s major areas in focus.
Cervical cancer is a cancer found anywhere in the cervix – the opening between the vagina and the uterus. Symptoms include blood spots or light bleeding between or following periods, menstrual bleeding which is longer and heavier than usual, and bleeding after the menopause.
Ana Ovey
