AstraZeneca, the manufacturer of the drug, announced that treatment with Imfinzi plus chemoradiotherapy did not improve survival compared with standard-of-care chemoradiotherapy alone in patients with locally advanced cervical cancer.
Updated findings from the phase 3 CALLA trial demonstrated that the use of Imfinzi (durvalumab) with chemoradiotherapy did significantly improve survival compared with chemoradiotherapy alone in patients with locally advanced cervical cancer.
In particular, Imfinzi plus chemoradiotherapy did not significantly improve progression-free survival (the time during and after treatment that a patient lives with cancer without worsening) versus chemoradiotherapy alone in this patient population, according to a press release from AstraZeneca, the manufacturer of the drug.
“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,” said Dr. Bradley J. Monk, a professor at the University of Arizona College of Medicine in Phoenix and principal investigator of the CALLA trial, in the release.
Researchers conducting the CALLA trial are assessing the safety, tolerability and effectiveness of standard-of-care chemoradiotherapy either with 1,500 milligrams of Imfinzi or placebo in 770 patients with locally advanced cervical cancer. Patients were given their assigned treatment every four weeks for up to 24 cycles or until cancer progressed, according to the release. This trial was conducted across 15 countries including the United States, Latin American, Europe, Asian and Africa.
“CALLA tested a novel immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress following available treatments,” said Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, in the release. “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 tumor types.”
Patients assigned Imfinzi plus chemoradiotherapy or chemoradiotherapy alone had similar safety and tolerability profiles with no new safety findings, according to the release. These data will be presented at a future medical meeting.
Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks it from interacting with the PD-1 and CD80 proteins. This has the potential to release the inhibition of immune responses and to stop the tumor from evading a patient’s immune system, according to the release. The drug has previously been approved by the Food and Drug Administration for the treatment of patients with unresectable stage 3 non-small cell lung cancer without disease progression after chemoradiotherapy.
Of note, cervical cancer is the eighth most common cancer worldwide and the ninth most deadly cancer globally, according to the release. Approximately 600,000 patients are diagnosed with cervical cancer annually, and nearly half of these patients (40% to 50%) are diagnosed in the locally advanced stage, meaning cancer that has spread to nearby lymph nodes or tissue. Patients with locally advanced cervical cancer who are treated with current standard of care — platinum-based chemotherapy with radiotherapy — have an estimated 40% risk for disease recurrence and a five-year survival rate between 65% and 70%. The standard of care for patients with locally advanced cervical cancer has not changed in over 20 years, according to the release.
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