The first doses of Advaxis‘ axalimogene filolisbac, or AXAL, have been administered to women with advanced cervical cancer in a Phase 3 trial of the treatment’s effectiveness after chemotherapy and radiation.
The multicenter, randomized, placebo-controlled AIM2CERV study (NCT02853604) is designed to compare the disease-free survival (DFS) rate of patients who take AXAL versus a placebo. The secondary, or adjuvant, therapy is being given to 450 women with locally advanced carcinoma of the cervix who have had concurrent chemotherapy and radiation treatments.
In addition to assessing whether AXAL can increase patients’ disease-free survival rate, the trial will cover its impact on overall survival rate and its safety and tolerability.
A key finding of a Phase 2 trial of AXAL was that it led to a 50 percent increase in patients’ 12-month overall survival rate.
AXAL received orphan-drug and fast-track designation as an adjuvant treatment for high-risk locally advanced carcinoma of the cervix, and orphan-drug designation for stage 2-4 cervical cancer.
The Phase 3 trial is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation under a Special Protocol Assessment granted in June 2016 by the U.S. Food and Drug Administration.
“While some women with cervical cancer are considered cancer-free after chemotherapy and radiation, a significant number will experience a recurrence of the disease that is often more aggressive and results in a poor prognosis. The global reach of the AIM2CERV study is intended to determine whether treatment with axalimogene filolisbac after chemotherapy and radiation can help prevent or delay such recurrences,” Daniel J. O’Connor, president and chief executive officer of Advaxis, said in a news release.
“Following recently published data that revealed cervical cancer mortality rates may be exponentially higher in African American women and significantly underestimated for all women, coupled with research last year showing fewer than half of patients with locally advanced cervical cancer receive standard-of-care therapy, the need for new treatment options is more clear now than ever,” O’Connor added.
Cervical cancer is often caused by the human papillomavirus (HPV). Although the infection can be prevented with HPV vaccines, only a third of the U.S. population has been vaccinated, and vaccination rates are even lower worldwide.
“Through our National Cervical Cancer Coalition (NCCC), every day we talk to women struggling with cervical cancer and the families of those who have lost loved ones to cervical cancer,” said Deborah Arrindell, vice president of health policy at the American Sexual Health Association, an umbrella organization that includes the NCCC. “Just as we need options to prevent HPV-related cancers, there is a significant need for more therapeutic options to treat those with cancer. No woman should die from cervical cancer.”
AXAL takes a new vaccine approach: using live attenuated bacteria. Scientists genetically altered Listeria monocytogenes to present the HPV-16 protein at the surface of cancer cells. Cancer-fighting T-cells recognize the protein, then go after HPV-positive cancer cells.
Results of the Phase 2 GOG-0265 trial (NCT01266460), which Advaxis presented in October of 2016, showed that AXAL was a promising therapy for patients with persistent or recurrent metastatic carcinoma of the cervix. The trial also showed that most patients were able to tolerate AXAL.
The full data set from the trial will be presented in March at the Society of Gynecologic Oncology’s 48th Annual Meeting on Women’s Cancer.