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Int J Gynecol Cancer ; 28(4): 764-772, 2018 05.
Article in English | MEDLINE | ID: mdl-29538258

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.


Subject(s)
Bacterial Toxins/therapeutic use , Heat-Shock Proteins/therapeutic use , Hemolysin Proteins/therapeutic use , Immunotherapy , Uterine Cervical Neoplasms/therapy , Adult , Aged , Antineoplastic Agents/therapeutic use , Bacterial Toxins/adverse effects , Cisplatin/therapeutic use , Female , Heat-Shock Proteins/adverse effects , Hemolysin Proteins/adverse effects , Humans , Middle Aged
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