Oncotarget A phase II study of axalimogene filolisbac for patients with anal cancer

Oncotarget Volume 11 Issue 15 reported that The Authors conducted this single-arm, multicenter, phase 2 trial in patients with persistent/recurrent, loco-regional or metastatic SCCA. Thirty-six patients were treated; 29 patients were evaluable for response.

One patient had a prolonged partial response.

Grade 3 adverse events were noted in 10 patients, with the majority being cytokine-release symptoms; one grade 4 adverse event was noted.

Dr. Cathy Eng from The MD Anderson Cancer Center, Houston, TX, USA said, "It is estimated that approximately 8600 new cases of anal cancer will be diagnosed in the United States in 2019, and 1160 people will die from the disease."

"It is estimated that approximately 8600 new cases of anal cancer will be diagnosed in the United States in 2019, and 1160 people will die from the disease."

- Dr. Cathy Eng, The MD Anderson Cancer Center

The most common risk factor for anal cancer is infection with human papillomavirus, which is found in more than 90% of anal cancer cases.

Among 37 patients, the overall response rate was 24%: 15% 33% with an observed prolonged complete response in one patient longer than 2 years.

A Phase IB study with pembrolizumab found similar benefits in patients with PD-L1 overexpressing unresectable anal cancer, with an ORR of 17% and a median PFS of 3.0 months.

Figure 1: Consort flow diagram. ^aSafety population: all patients who received at least one dose of ADXS11-001 (note: all 36 enrolled patients received at least one dose). ^bEfficacy population: all patients who received at least one dose of ADXS11-011 and had at least one post-baseline tumor response assessment. Note: 31 patients were planned for Stage 1 but patients consented at the time of the 31st patient were allowed to enroll, leading to 5 additional patients.

Based on these promising results, nivolumab and pembrolizumab are currently recommended as treatment options in previously treated patients with metastatic anal cancer.

While these two encouraging studies illustrate the potential benefits of immunotherapy in patients with recurrent or metastatic anal cancer there is still a need for additional therapies to treat this orphan disease.

The Umetani/Wu Research Team concluded in their Oncotarget Research Paper, "ADXS11-001 was safe and well-tolerated. Although the primary outcome was not reached, ADXS11-001 may benefit from further evaluation in combination with enhanced efficacy of therapy."

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DOI - https://doi.org/10.18632/oncotarget.27536

Full text - https://www.oncotarget.com/article/27536/text/

Correspondence to - Cathy Eng - cathy.eng@vumc.org

Keywords - anal neoplasms, immunotherapy, Listeria monocytogenes, papillomaviridae, phase II clinical trial

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