Immunotherapy Agent Well Tolerated in Dose-Escalation Cervical Cancer Trial

March 18, 2016

In an ongoing phase II clinical trial of an immunotherapy agent axalimogene filolisbac (AXAL), researchers in Georgia have demonstrated efficacy to increase the dose of this agent to treat patients with persistent or recurrent metastatic carcinoma of the cervix.

There is new hope in a treatment for cervical cancer, which claims the lives of approximately 4,100 women in the United States annually.

In an ongoing phase II clinical trial of an immunotherapy agent axalimogene filolisbac (AXAL), researchers in Georgia have demonstrated efficacy to increase the dose of this agent to treat patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).

The dose-escalation study is designed to evaluate the safety, efficacy, and immunological effect of AXAL administered at doses up to 1 x 1010 colony forming units (CFU) in repeat cycles of treatment in approximately 25 women.

Sharad Ghamande, MD, Director of Gynecology Oncology at GRU Cancer Center, Augusta University in Augusta, Ga., serves as principal investigator in this trial. Early trial data was first presented at a poster session during the Society for Immunotherapy of Cancer 2015 Annual Meeting, where results from nine patients showed that AXAL could be safely administered with prophylactic antibiotics up to 1 x1010 CFU, a tenfold increase from prior dosing regimens at 1 x 109.

Adverse events (AE) at this high dose are consistent with previous AEs--predominately grade 1 or grade 2, transient events that self-resolved or were resolved with medications such as anti-inflammatory agents (NSAIDS) and antiemetics. The high-dose expansion phase will include 15 patients.

For women whose disease has progressed following initial treatment, this treatment looks promising.

“This study will further explore what our research has shown to date--that a higher dose drives an increase in protein expression in the cytosol and results in greater generation of T cells to the HPV [human papillomavirus] target,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis, in a press release. Advaxis, Inc. is a clinical-stage biotechnology company developing cancer immunotherapies.

Caused by certain strains of HPV, this disease affects about 13,000 women who are diagnosed each year, and although the HPV vaccine (Gardisil, Gardisil 9, and Cervarix) may prevent infection in this next generation, the women who were ineligible to receive a vaccine are at risk for this cancer type. It should be noted that HPV infection of certain high-risk strains can lead to other gynecological cancers in women, and oropharyngeal, genitourinary, and anal cancers in both men and women.