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Alliance Foundation Trials Opens Its First Gynecological Cancer Study
The Alliance Foundation Trials, LLC (AFT), in partnership with Genentech, a member of the Roche Group, today announced the launch of the first gynecological oncology study in the AFT portfolio - AFT-50 EndoMAP [A phase IB/II umbrella study for patients with recurrent or persistent endometrial cancer]. The AFT-50 EndoMAP study will evaluate the efficacy and safety of targeted agents paired with immunotherapy with atezolizumab for patients with recurrent or persistent endometrial cancer. The study is launching with three study cohorts; additional cohorts to be treated with or without atezolizumab are under development.
Endometrial cancer is the most common gynecologic cancer in the United States and affects an estimated 66,500 women in the U.S. every year, according to the American Cancer Society. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer. Limited options are available for this patient population.
“We are learning that immunotherapy works for women with endometrial cancer,” said Brian M. Slomovitz, MD, MS, Study Chair. Dr. Slomovitz is the Director of Gynecologic Oncology at Mount Sinai Medical Center Miami Beach. “The AFT-50 EndoMAP study aims to rapidly identify new approaches to improve today’s treatment options for women with endometrial cancer by combining novel agents to immunotherapy. These agents will be selected based on the genetic makeup of the tumor. This promising approach will ideally choose the right combination for the right individual.”
AFT-50 EndoMAP is an immunotherapy study for patients with recurrent or persistent endometrial cancer that combines the immune checkpoint inhibitor, atezolizumab, with targeted agents that are selected based on next-generation sequencing of the genetic components of the tumor. In this biomarker-driven study, prospective patients will be pre-screened using this sequencing technology. Based on the sequencing results, patients will be assigned to a study arm with a targeted therapy plus atezolizumab. Current study cohorts include doublets of atezolizumab plus one of the following: bevacizumab (anti-VEGF); ipatasertib (AKT inhibitor); or talazoparib (PARP inhibitor from Pfizer). The study allows for additional cohorts as the study progresses. Approximately 20 patients will be enrolled in each cohort. The primary endpoint of the study is overall response rate in each of the arms.
“AFT is excited to launch our first gynecological oncology trial pairing immunotherapy with treatments selected per tumor next-generation sequencing,” said David Kozono, MD, PhD, AFT Executive Officer and Alliance Immuno-Oncology Committee Co-Chair. “It truly represents state-of-the-art precision medicine.”
“Genentech recognizes that clinical and scientific expertise comes from the entire medical research community coalescing around a common mission,” said Yvonne Lin, MD, MS, Senior Medical Director and Gynecologic Cancers Clinical Lead at Genentech. “This recognition serves as the foundation for this novel partnership between Genentech and AFT, and we are thrilled to continue our commitment to developing transformative medicines and diagnostics for women with gynecologic malignancies.”
Currently, the study is open at institutions throughout the U.S. if they are associated with Alliance Foundation Trials, LLC. Additional information on the study and participating study centers is available on ClinicalTrials.Gov [NCT04486352] at the following link: https://clinicaltrials.gov/ct2/show/NCT04486352
About Alliance Foundation Trials, LLC
Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network, research collaborators, and non-NCI funding sources. AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer. Current AFT studies are funded by industry collaborators and the Patient-Centered Outcomes Research Institute (PCORI).