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Poster Presentation
ADXS11-001 immunotherapy targeting HPV-E7: final results from a Phase II study in Indian women with recurrent cervical cancer
  1. Robert G Petit1,
  2. Ajay Mehta2,
  3. Minish Jain3,
  4. Sudeep Gupta4,
  5. Rajnish Nagarkar5,
  6. Vijay Kumar6,
  7. Sumana Premkumar7,
  8. Rakesh Neve8,
  9. Subhashini John9 and
  10. Partha Basu10
  1. Aff1 grid.422071.2Advaxis. Inc NJ USA
  2. Aff2 grid.428329.6Central India Cancer Research Institute Nagpur Maharashtra India
  3. Aff3 grid.419353.90000 0004 1805 9940Ruby Hall Clinic Maharashtra India
  4. Aff4 grid.410871.b0000000417695793Tata Memorial Hospital Maharashtra India
  5. Aff5 Curie Manavata Cancer Center Maharashtra India
  6. Aff6 MV Hospital and Research Center Chennai Tamil Nadu India
  7. Aff7 Dr. Kamakshi Memorial Hospital Chennai Tamil Nadu India
  8. Aff8 grid.459956.20000000418042495Smt. Kashibai Navale Medical College and General Hospital Pune Maharashtra India
  9. Aff9 grid.11586.3b0000000417678969Christian Medical College Vellore Vellore Tamil Nadu India
  10. Aff10 grid.418573.cChittaranjan National Cancer Institute Kolkata West Bengal India

https://doi.org/10.1186/2051-1426-2-S3-P92

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    Meeting abstracts

    Background

    ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a tLLO-HPV-16-E7 fusion protein targeting HPV-transformed cells. The Lm vector serves as its own adjuvant and infects APC where it cross presents HPV-E7-tLLO fusion peptide, stimulating MHC class 1 and 2 pathways resulting in HPV-E7 specific T cell immunity. Lm-LLO-E7-015 (Clinical Trials Registry India #CTRI/2010/091/001232), is a randomized Phase II study designed to evaluate the safety and efficacy of ADXS11-001 +/- Cisplatin in patients with recurrent cervical cancer in India.

    Methods

    110 patients were randomized to either 3 doses of ADXS11-001 at 1 × 109 cfu or 4 doses of ADXS11-001 at 1 × 109 cfu with Cisplatin chemotherapy (40 mg/m2, weekly x5). Naproxen and oral Promethazine were given as premedications. Patients received CT scans at baseline and 3, 6, 9, 12 and 18 months. The primary endpoint was overall survival.

    Results

    Final 12-month survival was 32% (35/109), 18-month survival was 22% (24/109) and 24-month survival was 18% (16/91). The response rate was 11% (5 CRs and 6 PRs/109) with tumor responses observed in both treatment arms; 31 additional patients had stable disease ≥ 3 months, for a disease control rate of 38% (42/109). Average duration of response in both treatment groups was 9.5 months. Long term survivors (LTS; ≥18 months) included patients with tumor shrinkage and patients with increased tumor burden as their best tumor response overall; 8% (2/24) of LTS failed at least two prior treatments; and 25% (3/11) of LTS were ECOG performance status 2 at baseline. Activity against different high-risk HPV strains was observed. The addition of Cisplatin to ADXS11-001 did not improve survival or tumor response over ADXS11-001 alone but contributed to toxcity. Baseline ECOG performance status, type of prior therapy, or aggressiveness of disease had no significant effect on survival or tumor response. ADXS11-001 was well tolerated as 62% (68/109) of patients reported no adverse events and 38% (41/109) of patients reported only mild transient adverse events (G1-2) that occurred on the day of infusion. The incidence of SAEs possibly related/ related to ADXS11-001 was 1% G3 (0% G4-5).

    Conclusions

    ADXS11-001 appears to have significant clinical activity in patients with recurrent cervical cancer. The observed prolonged survival, objective tumor responses, and stabilization of recurrent disease compare favorably with more toxic chemotherapy treatment options and support ADXS11-001 as an active agent in the treatment of cervical cancer.