Advaxis, Inc. recently announced in a press release that results from the first stage of its ongoing Phase II clinical trial (GOG-0265) investigating the company’s axalimogene filolisbac (ADXS-HPV) technology in the treatment of patients with persistent or recurring metastatic carcinoma of the cervix, will be presented during the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif., on September 17, 2015.
Cervical cancer is one of the most common cancers in women worldwide. Most cases are associated with a sexually transmitted genital infection with the human papillomavirus (HPV). If found early, cervical cancer is highly treatable by surgery, chemotherapy or radiotherapy, with patients attaining a long survival with good quality of life. However, in its metastatic stage, when malignant cells have spread to nearby organs and tissues, or in recurrent patients that have failed at least one of the anti-cancer treatments, therapies and survival become limited. Tom Hertzog, MD, Clinical Director at the University of Cincinnati Cancer Institute, responsible for disclosing the results of the clinical trial in question stated in a news release, “We see the potential for axalimogene filolisbac to fill a significant unmet need in the treatment of this disease and look forward to presenting these Stage 1 data at the AGOS annual meeting.”
Axalimogene filolisbac, Advaxis’s lead Lm Technology is a vaccine of bioengineered live attenuated Listeria monocytogenes (Lm) bacteria that stimulate the patient’s own immune system to selectively target cancer cells for elimination, while simultaneously reducing the defenses present in the tumor microenvironment. This vaccine “tricks” the patient’s immune system into thinking that the cancer cells are bacterially infected cells and should therefore be eliminated. Targeting HPV-associated cancers is currently being studied in clinical trials to treat head and neck cancer, anal cancer and cervical cancer.
Concerning cervical cancer, a Phase II clinical trial in India involving 110 patients with recurring disease showed that axalimogene filolisbac alone or in combination with cisplatin, a popular anti-tumor drug, promoted prolonged survival of the patients and an objective tumor reduction, within a manageable safety profile. These promising results prompted the Gynecologic Oncology Group (GOG, NRG Oncology) to initiate the current Phase II clinical trial of axalimogene filolisbac involving US patients (GOG-0265), under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
Enrolling a total of 67 patients previously unsuccessfully treated for cervical cancer, the first stage of the GOG-0265 trial aims to assess axalimogene filolisbac safety, tolerability and efficacy, mainly focusing on the 12-month overall survival rate of the patients, number of patients with dose-limiting toxicities and the frequency and severity of adverse effects. Further information about this trial can be found at ClinicalTrials.gov.
Preliminary results released yearly this year were promising, having met the predetermined safety and the 12-months survival criteria required to proceed to the second stage of the trial currently ongoing.
Expectations are now high to find out in detail the full results of the first stage of this clinical study and whether these will have the necessary efficacy and safety levels to allow further development of Advaxis’ axalimogene filolisbac into an effective cervical cancer therapy. Given the encouraging preliminary results of the study this scenario is not totally unexpected.