Advaxis will present data from its Phase 2 clinical trial evaluating a new vaccine therapy, axalimogene filolisbac, for the treatment of metastatic cervical cancer at the Society of Gynecologic Oncology’s (SGO) 48th Annual Meeting on Women’s Cancer March 12-15 in National Harbor, Maryland.
Charles A. Leath III, MD, associate professor of obstetrics and gynecology at the University of Alabama, will present the abstract, which was accepted for late-breaking presentation. He will highlight final data from the GOG-0265 Phase 2 trial (NCT01266460), which evaluated the safety and activity of the immunotherapy in patients with metastatic cervical cancer.
The poster presentation is titled “A prospective phase 2 trial of the listeria-based HPV immunotherapy axalimogene filolisbac in second and third-line metastatic cervical cancer: A NRG oncology group trial.”
Axalimogene filolisbac is an immunotherapy vaccine that targets HPV-associated cancers. It is currently being evaluated for three potential indications: cervical cancer, head and neck cancer, and anal cancer.
Preliminary data from the GOG-0265 study, presented last October, revealed that the vaccine induced a 50 percent increase in the expected 12-month overall survival for patients with recurrent metastatic cervical cancer.
“Axalimogene filolisbac continues to gain validation for its potential as a therapy to treat women with this advanced cervical cancer who have no treatment options other than a repeat of chemotherapy and radiation,” Daniel J. O’Connor, president and CEO of Advaxis, said in a press release. “We look forward to sharing this data, which supports our plan to initiate a Phase 3 study in metastatic cervical cancer later this year.”
Axalimogene filolisbac is based on Advaxis’s program in Listeria monocytogenes (Lm) technology, which uses bioengineered live Lm attenuated bacteria to generate fighting T-cells directed against cancer antigens and to neutralize immunosuppressive cells, like regulatory T-cells and myeloid-derived suppressor cells, that protect the tumor microenvironment from being attacked by the immune system.
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted the immunotherapy candidate with Orphan Drug status for all three potential indications, and the EMA has granted the drug advanced therapy medicinal product status for the treatment of cervical cancer.
Late-breaking abstracts are accepted if they demonstrate timely findings of high scientific impact. Those abstracts selected for scientific plenary will also be published in the journal Gynecologic Oncology.