Imfinzi fails to improve survival in locally advanced cervical cancer
Updated Phase 3 CALLA trial results demonstrated that using Imfinzi (durvalumab) with chemoradiotherapy significantly improved survival compared to chemoradiotherapy alone in patients with cervical cancer locally advanced.
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) compared to chemoradiotherapy alone in this patient population, according to a press release from AstraZeneca, the maker of the drug.
“Although today’s results are not statistically significant, they underscore the need for further evaluation of new therapeutic options and will inform future strategies to improve the treatment of patients with cervical cancer. ‘locally advanced uterus,’ said University professor Dr. Bradley J. Monk. of the Arizona College of Medicine in Phoenix and principal investigator of the CALLA trial, in the release.
Researchers conducting the CALLA trial are evaluating the safety, tolerability, and effectiveness of standard chemoradiotherapy with 1,500 milligrams of Imfinzi or a placebo in 770 patients with locally advanced cervical cancer. Patients received their assigned treatment every four weeks for up to 24 cycles or until the cancer progressed, according to the statement. This trial was conducted in 15 countries, including the United States, Latin America, Europe, Asia and Africa.
“CALLA has tested a new immunotherapy approach in locally advanced cervical cancer, a devastating and complex disease where many patients progress after available treatments,” said Susan Galbraith, executive vice president of research. and oncology development at AstraZeneca, in the release. “Although the results did not meet our expectations, the learnings from the trial will advance our understanding and application of immunotherapy in our extensive clinical development program, exploring the benefits of Imfinzi in many tumor types.
Patients who received Imfinzi plus chemoradiotherapy or chemoradiotherapy alone had similar safety and tolerability profiles with no new safety results, 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 prevents it from interacting with the PD-1 and CD80 proteins. This has the potential to release inhibited immune responses and prevent the tumor from escaping a patient’s immune system, according to the statement. The drug has already 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.
It should be noted that cervical cancer is the eighth most common cancer in the world and the ninth deadliest cancer in the world, according to the release. Approximately 600,000 patients are diagnosed with cervical cancer each year, and almost half of these patients (40% to 50%) are diagnosed at a locally advanced stage, i.e. cancer that has spread to lymph nodes or nearby tissue. Patients with locally advanced cervical cancer who are treated with the current standard of care – platinum-based chemotherapy with radiation therapy – have an estimated 40% risk of disease recurrence and survival at five years between 65% and 70%. The standard of care for patients with locally advanced cervical cancer has not changed in more than 20 years, the statement said.
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