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Advaxis Presents Oral Late-breaking Data on Phase 2 GOG-0265 Study of Axalimogene Filolisbac at SGOs Annual Meeting on Womens Cancer

(March 15, 2017)

- Achieved primary objective of 12-month survival rate, demonstrating axalimogene filolisbac is an active therapy in metastatic cervical cancer


- Unprecedented 12-month survival rate for metastatic cervical cancer observed

PRINCETON, N.J., March 15, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, presented data from the GOG-0265 study at the Society of Gynecologic Oncologys Annual Meeting on Womens Cancer in National Harbor, MD.  GOG-0265 is a single arm, Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).  The primary endpoints of the study were to assess the safety and efficacy of axalimogene filolisbac in women with PRmCC.  The primary efficacy endpoint was overall survival at 12 months from initial treatment with axalimogene filolisbac. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The final efficacy results of GOG-0265 demonstrated that 38% of patients (n = 19/50) with heavily pretreated PRmCC were alive 12 months following treatment with axalimogene filolisbac.  The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate.  The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with PRmCC who participated in 17 previous phase 2 studies conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology.  Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%.  As a result, the 38% 12-month survival rate of patients treated with axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting.  The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02.  A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months.

?The 12-month survival rate of axalimogene filolisbac reached unprecedented levels in this study, which is both impressive and important given the lack of innovation in metastatic cervical cancer, said Warner K. Huh, MD, Division Director of Gynecologic Oncology at the University of Alabama at Birmingham, and Lead Investigator of the study.

The safety profile was consistent with previous clinical experience.  The most common Grade 1 or Grade 2 treatment-related adverse events (TRAEs) were hypotension and symptoms related to cytokine release (e.g., nausea, chills, fever).  Eighteen out of 50 patients experienced a Grade 3 TRAE and two out of 50 patients experienced a Grade 4 TRAE, which were hypotension and symptoms related to cytokine release. 

The abstract was selected by SGO for prominence as an oral late-breaking presentation by Charles A. Leath III, M.D., MSPH, Associate Professor of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine, entitled, ?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, on March 14 at 2:30 p.m. ET. Slides from the presentation are available at www.advaxis.com/sgo2017.

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