Oncotarget

Research Papers:

A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer

PDF |  Full Text  |  Supplementary Files  |  How to cite  |  Press Release

Oncotarget. 2020; 11:1334-1343. https://doi.org/10.18632/oncotarget.27536

Metrics: PDF 1146 views  |   Full Text 1892 views  |   ?  

Cathy Eng _, Marwan Fakih, Manik Amin, Van Morris, Howard S. Hochster, Patrick M. Boland and Hope Uronis

Abstract

Cathy Eng1, Marwan Fakih2, Manik Amin3, Van Morris1, Howard S. Hochster4, Patrick M. Boland5 and Hope Uronis6

1 MD Anderson Cancer Center, Houston, TX, USA

2 City of Hope, Duarte, CA, USA

3 Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA

4 Rutgers Cancer Institute, New Brunswick, NJ, USA

5 Roswell Park Cancer Institute, Buffalo, NY, USA

6 Duke Cancer Institute, Durham, NC, USA

Correspondence to:

Cathy Eng,email: cathy.eng@vumc.org

Keywords: anal neoplasms; immunotherapy; Listeria monocytogenes; papillomaviridae; phase II clinical trial

Received: November 08, 2019     Accepted: March 14, 2020     Published: April 14, 2020

ABSTRACT

Squamous cell carcinoma of the anorectal canal (SCCA) is a rare HPV-related malignancy that is steadily increasing in incidence. A high unmet need exists for patients with persistent loco-regional and metastatic disease. Axalimogene filolisbac (ADXS11-001) is an investigational immunotherapy that stimulates tumor-specific responses against HPV-associated cancers, and has demonstrated benefit in metastatic cervical cancer. We conducted this single-arm, multicenter, phase 2 trial in patients with persistent/recurrent, loco-regional or metastatic SCCA. Patients received ADXS11-001, 1 × 109 colony-forming units intravenously every 3 weeks. A Simon 2-stage design was used to test primary co-endpoints of overall response rate (ORR) and 6-month progression-free survival (PFS) rate. Study would proceed to full enrollment if ORR ≥ 10% or 6-month PFS rate ≥ 20%. Thirty-six patients were treated; 29 patients were evaluable for response. One patient had a prolonged partial response (3.4% ORR). The 6-month PFS rate was 15.5%. Grade 3 adverse event were noted in 10 patients, with the majority being cytokine-release symptoms; one grade 4 adverse event was noted. No grade 5 adverse events occurred. ADXS11-001 was safe and well-tolerated in patients with SCCA. However, this study did not meet either primary endpoint. ADXS11-001 may be more beneficial when administered in combination with other cytotoxic or targeted agents.



Creative Commons License All site content, except where otherwise noted, is licensed under a Creative Commons Attribution 4.0 License.
PII: 27536