Advaxis, Inc. announced that the Gynecologic Oncology Group (GOG), now part of NRG Oncology (NRG) will present additional preliminary data from a two-stage Phase 2 study of its lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. GOG/NRG-0265 is a single-arm two-stage, Phase 2 multicenter study (NCT01266460). Stage 1 of the trial enrolled 26 AXAL-treated patients who received up to three doses at 1x109 colony forming units administered in 28 day intervals. Results from Stage 1 demonstrated a twelve-month survival rate of 38.5%, which exceeds prior historical GOG trials in this patient population. The twelve-month survival rate among the 69% of patients who received the maximum three per protocol doses was 56%, with a 12.1-month median overall survival. Safety and efficacy results of Stage 1 met the criteria for the initiation of Stage 2, which was amended for continuous cycles of AXAL (greater than three doses). Twenty-four patients were treated with AXAL in Stage 2. However, a temporary clinical hold limited overall exposure to the immunotherapy, which necessitated 10 patients who had not progressed to discontinue AXAL treatment. Further, only 12 of the 24 patients received three or more doses. Demographics in the truncated Stage 2 cohort were similar to Stage 1, but a substantially higher proportion of patients were pre-treated with bevacizumab (83% (Stage 2) vs. 31% (Stage 1)). At a median follow-up of 8.7 months, these Stage 2 results demonstrate a 42% six-month overall survival rate, which increases to 67% in those 12 patients who received three or more doses of AXAL. Preliminary results from Stage 2 appear consistent with the promising survival results from Stage 1 in a more heavily bevacizumab pre-treated population. Investigator assessment of tumor best response showed disease control rates (CR+PR+SD) of 27% and 37% in Stage 1 and 2, respectively. Of particular note, a patient in Stage 2 experienced a complete response following three doses of AXAL. This patient continues to be followed with no evidence of disease at 11 months. Treatment with AXAL will resume under a compassionate use single-patient IND. The safety profile across both stages was similar, with primarily grade one and two treatment-related events such as fatigue, chills, fever, nausea. Grade three events (n = 4 in Stage 1) included hypotension and cytokine release syndrome. No grade four or five treatment-related adverse events were observed. Given the substantial proportion of Stage 2 patients that discontinued treatment with AXAL as a result of the clinical hold, Advaxis and the GOG/NRG agreed to re-enroll a new cohort of Stage 2 patients. The re-enrollment of Stage 2 is expected to commence shortly. The Company and the GOG Foundation plan to commence enrollment to an international Phase 3 adjuvant study, AIM2CERV, for patients with high risk, locally advanced cervical cancer.