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

Publication ,  Journal Article
Eng, C; Fakih, M; Amin, M; Morris, V; Hochster, HS; Boland, PM; Uronis, H
Published in: Oncotarget
April 14, 2020

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.

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Published In

Oncotarget

DOI

EISSN

1949-2553

Publication Date

April 14, 2020

Volume

11

Issue

15

Start / End Page

1334 / 1343

Location

United States

Related Subject Headings

  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
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Eng, C., Fakih, M., Amin, M., Morris, V., Hochster, H. S., Boland, P. M., & Uronis, H. (2020). A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer. Oncotarget, 11(15), 1334–1343. https://doi.org/10.18632/oncotarget.27536
Eng, Cathy, Marwan Fakih, Manik Amin, Van Morris, Howard S. Hochster, Patrick M. Boland, and Hope Uronis. “A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer.Oncotarget 11, no. 15 (April 14, 2020): 1334–43. https://doi.org/10.18632/oncotarget.27536.
Eng C, Fakih M, Amin M, Morris V, Hochster HS, Boland PM, et al. A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer. Oncotarget. 2020 Apr 14;11(15):1334–43.
Eng, Cathy, et al. “A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer.Oncotarget, vol. 11, no. 15, Apr. 2020, pp. 1334–43. Pubmed, doi:10.18632/oncotarget.27536.
Eng C, Fakih M, Amin M, Morris V, Hochster HS, Boland PM, Uronis H. A phase II study of axalimogene filolisbac for patients with previously treated, unresectable, persistent/recurrent loco-regional or metastatic anal cancer. Oncotarget. 2020 Apr 14;11(15):1334–1343.

Published In

Oncotarget

DOI

EISSN

1949-2553

Publication Date

April 14, 2020

Volume

11

Issue

15

Start / End Page

1334 / 1343

Location

United States

Related Subject Headings

  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis