ADXS11-001 immunotherapy targeting HPV-E7: Final results from a phase 2 study in Indian women with recurrent cervical cancer.
2014 ASCO Annual Meeting
J Clin Oncol 32:5s, 2014 (suppl; abstr 5610)
2014 ASCO Annual Meeting!
Session: Gynecologic Cancer
Type: General Poster Session
Time: Saturday May 31, 8:00 AM to 11:45 AM
Location: S Hall A2
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Author(s): Partha Basu, Ajay O. Mehta, Minish Mahendra Jain, Sudeep Gupta, Rajnish Vasant Nagarkar, Vijay Kumar, Sumana Premkumar, Rakesh Neve, Subhashini John, Robert G. Petit; Chittaranjan National Cancer Institute, Kolkata, India; Central India Cancer Research Institute, Nagpur, India; Ruby Hall Clinic, Pune, India; Tata Memorial Hospital, Mumbai, India; Curie Manavata Cancer Center, Nashik, India; MV Hospital and Research center, Lucknow, India; Dr. Kamakshi Memorial Hospital, Tamil Nadu, India; Smt. Kashibai Navale Medical College and General Hospital, Maharashtra, India; Christian Medical College Vellore, Tamil Nadu, India; Advaxis, Inc., Princeton, NJ
Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it cross presents, stimulating MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe final results from Lm-LLO-E7-015, a randomized P2 study designed to evaluate the safety and efficacy of ADXS11-001 with and without cisplatin in 110 patients with recurrent cervical cancer in India; previously treated with chemotherapy, radiotherapy or both. Methods: Patients were randomized to either 3 doses of ADXS11-001 at 1 x 109 cfu or 4 doses of ADXS11-001 at 1 x 109 cfu with cisplatin chemotherapy (40 mg/m2). Naprosyn and oral promethazine were given as premedications and a course of ampicillin was given 72h after infusion. Patients received CT scans at baseline and 3, 6, 9, 12 and 18 months. The primary endpoint was overall survival. Results: The final 12 month survival was 36% (39/110) and 18-month survival was 28% (31/110). The response rate was 11% (6 CRs and 6 PRs/110) with tumor responses observed in both treatment arms; 35 additional patients had stable disease > 3 months, for a disease control rate of 43% (47/110). Average duration of response in both treatment groups was 10.5 months. Activity against different high-risk HPV strains was observed. The incidence of SAEs possibly related or related to ADXS11-001 was 2% (G3). The majority of non-serious adverse events were predominately infusion associated, and either resolved on their own or responded to symptomatic treatment. Conclusions: The addition of cisplatin to ADXS11-001 did not significantly improve survival outcomes or tumor responses. Baseline ECOG performance status, type of prior therapy, or aggressiveness of disease had no effect on survival outcomes and tumor responses. The 36% 12 month survival, 28% 18 month survival, and 11% response rate observed in this recurrent disease setting is encouraging and suggests that ADXS11-001 is an active agent in recurrent cervical cancer. Additional sub-analyses will be presented at the meeting.
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