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Clinical Trial
. 2018 May;28(4):764-772.
doi: 10.1097/IGC.0000000000001235.

A Randomized Phase 2 Study of ADXS11-001 Listeria monocytogenes-Listeriolysin O Immunotherapy With or Without Cisplatin in Treatment of Advanced Cervical Cancer

Partha Basu, Ajay Mehta, Minish Jain, Sudeep Gupta, Rajnish V Nagarkar, Subhashini John, Robert Petit
Clinical Trial

A Randomized Phase 2 Study of ADXS11-001 Listeria monocytogenes-Listeriolysin O Immunotherapy With or Without Cisplatin in Treatment of Advanced Cervical Cancer

Partha Basu et al. Int J Gynecol Cancer. 2018 May.

Abstract

Objectives: A global unmet medical need exists for effective treatments for persistent, recurrent, or metastatic cervical cancer, as patients have a short life expectancy. Recently, immunotherapies have shown promising survival benefits for patients with advanced forms of cancer. Axalimogene filolisbac (ADXS11-001), a Listeria monocytogenes immunotherapy with a broad effect on the immune system, is under investigation for treatment of human papillomavirus-associated cancers including cervical cancer.

Methods: This phase 2 study evaluated the safety and efficacy of ADXS11-001, administered with or without cisplatin, in patients with recurrent/refractory cervical cancer following prior chemotherapy and/or radiotherapy. A total of 109 patients were treated, and 69 were evaluable for tumor response at equal to or more than 3 months postbaseline.

Results: Median overall survival (OS) was comparable between treatment groups (ADXS11-001: 8.28 months; 95% confidence interval [CI], 5.85-10.5 months; ADXS11-001 + cisplatin: 8.78 months; 95% CI, 7.4-13.3 months). The 12- and 18-month milestone OS rates were 30.9% versus 38.9%, and 23.6% versus 25.9% for each group, respectively (34.9% and 24.8% combined). Median progression-free survival (6.10 vs 6.08 months) and the overall response rate (17.1% vs 14.7%) were similar for both groups. ADXS11-001 was generally well tolerated; adverse events were predominantly mild to moderate in severity and not related to treatment. More adverse events were reported in the combination group (429 vs 275).

Conclusions: These promising safety and efficacy results, including the encouraging 12-month 34.9% combined OS rate, warrant further investigation of ADXS11-001 for treatment of recurrent/refractory cervical cancer.

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Conflict of interest statement

P.B. has received research funding from Advaxis, Inc, while working for Chittaranjan National Cancer Institute; S.G. has received research funding from Sanofi-Aventis; R.P. is employed by and owns stock from Advaxis, Inc. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
CONSORT diagram. PI, Principal investigator.
FIGURE 2
FIGURE 2
Kaplan-Meier curve for OS in the efficacy population, survival follow-up (n = 109) by treatment group. CIS, Cisplatin; LCL, lower confidence limit; UCL, upper confidence limit; n, number.
See this image and copyright information in PMC

References

    1. World Health Organization. International Agency for Research on Cancer. In: Latest World Cancer Statistics. Global Cancer Burden Rises to 14.1 Million New Cases in 2012: Marked Increase in Breast Cancers Must Be Addressed [press release]. Lyon, France: International Agency for Research on Cancer; 2013.
    1. Bruni L, Barrionuevo-Rosas L, Albero G, et al. Human Papillomavirus and Related Diseases in the World. Summary Report. Barcelona, Spain: ICO Information Centre on HPV and Cancer (HPV Information Centre); 2017.
    1. World Health Organization/Institut Català d'Oncologia Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers. Summary Report Update. Barcelona, Spain: WHO/ICO HPV Information Centre; 2010.
    1. Wheeler CM, Hunt WC, Joste NE, et al. Human papillomavirus genotype distributions: implications for vaccination and cancer screening in the United States. J Natl Cancer Inst. 2009;101:475–487. - PMC - PubMed
    1. Clifford GM, Rana RK, Franceschi S, et al. Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev. 2005;14:1157–1164. - PubMed

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