Advaxis Reports 37.5 Percent 12-month Overall Survival Rate For GOG-0265 Trial

(RTTNews) - Shares of Advaxis Inc. (ADXS) dropped more than 13 percent in pre-market activity before paring losses to just more than 5 percent after the company said that it was not able to complete the second stage of the Phase 2 GOG-0265 trial as designed due to a clinical hold that affected its clinical development programs last year.

GOG-0265 is a single-arm, open-label Phase 2 multicenter study designed to evaluate the safety and activity of cancer therapy axalimogene filolisbac in patients with persistent or recurrent metastatic carcinoma of the cervix, or PrmCC, in a standard Simon two-stage design.

Advaxis noted that the preliminary results from the second stage of the study prior to the clinical hold showed that treatment with axalimogene filolisbac resulted in an overall survival rate that was consistent with the first stage of the study.

The first stage of the study, which was previously completed, included a six-patient safety run-in and enrolled 26 patients. The first stage met the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment.

Advaxis said that the second stage of the study enrolled 24 patients prior to the clinical hold. A preliminary analysis of the 12-month overall survival data from the 24 patients enrolled in the second stage showed that treatment with axalimogene filolisbac resulted in a 37.5 percent 12-month overall survival rate.

The preliminary findings of the second stage of the study was 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.

It also exceeded the 12-month survival rate of 25 percent that would have been expected, based on protocol defined prognostic factors of patients who enrolled in the study.

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.

Warner Huh, division director of Gynecologic Oncology at the University of Alabama at Birmingham, and lead investigator of the study said, "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."

Cervical cancer is the fourth most common cancer in women worldwide. According to the National Cancer Institute, about 13,000 new cases are expected to be diagnosed in the U.S. in 2016, and 4,100 people will likely die of the disease.