Advaxis (ADXS) Announces Topline Data from Phase 2 GOG-0265 Stage 2; OS Data Consistent with Prior Results

October 24, 2016 8:02 AM EDT
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Advaxis, Inc. (Nasdaq: ADXS) announced topline results from the early closure of stage 2 of the Phase 2 GOG-0265 trial, conducted by the Gynecologic Oncology Group (GOG, now part of NRG Oncology) and supported by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).

GOG-0265 is a single-arm, open-label Phase 2 multicenter study (NCT01266460) designed to evaluate the safety and activity of axalimogene filolisbac in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) in a standard Simon two-stage design. The first stage of the study included a six-patient safety run-in and enrolled 26 patients. The first stage of the study was previously completed, meeting the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment. The second stage enrolled 24 patients prior to the clinical hold that affected Advaxis’ clinical development programs last year. The second stage was not completed as designed due to the clinical hold.

A preliminary analysis of 12-month overall survival data from 24 patients enrolled in the second stage prior to the clinical hold showed that treatment with axalimogene filolisbac resulted in a 37.5 percent 12-month overall survival rate. These preliminary findings are consistent with earlier data that showed a 38.5 percent 12-month overall survival rate in 26 patients enrolled in the first stage of the study, despite modest differences in dosing schedules between the two stages.

Based on protocol defined prognostic factors of patients who enrolled in the study (n=50), a 12-month survival rate of 25 percent would have been expected. Comparing this 25 percent 12-month overall survival rate to the 38 percent 12-month overall survival rate actually observed across the total study population, treatment with axalimogene filolisbac resulted in a 52 percent increase in the expected 12-month overall survival rate.

“These data demonstrate a meaningful improvement in 12-month overall survival rate compared to historical GOG studies,” said Warner K. Huh, M.D., division director of Gynecologic Oncology at the University of Alabama at Birmingham, and lead investigator of the study. “Historical survival rates for patients with PRmCC underscore the need for additional treatment options for patients and these results illustrate the promising therapeutic potential for axalimogene filolisbac in women with this rare cancer.”

In the second stage of the study, 15 out of 24 patients experienced a Grade 1 or Grade 2 treatment-related adverse event (TRAE). The most common Grade 1 or Grade 2 TRAEs were hypotension and symptoms related to cytokine release (e.g., nausea, chills, fever). Nine out of 24 patients experienced a Grade 3 TRAE and two out of 24 patients experienced a Grade 4 TRAE, which were hypotension and symptoms related to cytokine release.

“We are very encouraged by these data and look forward to presenting and discussing a more detailed analysis of the trial results at an upcoming medical society meeting,” said Daniel J. O’Connor, president and chief executive officer of Advaxis. “We believe that a more than 50 percent increase in 12-month overall survival rate is clinically meaningful, and Advaxis plans to pursue registrational opportunities in Europe in 2017.”

Axalimogene filolisbac was recently classified as an advance therapy medicinal product (ATMP) in the EU, has received U.S. Food and Drug Administration (FDA) Fast Track Designation as an adjuvant therapy for treating high risk, locally advanced cervical cancer (HRLACC), and has been granted U.S. orphan drug designation for the treatment of invasive cervical cancer.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide.2 An estimated 13,000 new cases will be diagnosed in the United States in 2016, and 4,100 people will die of the disease, according to the National Cancer Institute. Persistent HPV infection is the most important factor in the development of cervical cancer, research shows.3,4 According to the ICO Information Centre on HPV and Cervical Cancer, about 4.4 percent of women in the United States are estimated to harbor high-risk cervical HPV infection at a given time, and about 72 percent of cervical cancers are attributed to high-risk HPV strains.5 The prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown.6. According to the American Cancer Society, the 5-year mortality rate for metastatic disease is at just 17 percent, with the area continuing to be a high unmet medical need.7



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