Cervical Cancer Patient Achieves Long-lasting Response to AXAL in Clinical Trial

One of nine cervical cancer patients treated with AXAL achieved a long-lasting partial response to the therapy, according to a Phase 1 study.

The treatment’s maker, Advaxis, presented the results in a poster session at a National Cancer Research Institute conference in Liverpool, England. The trial covered patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC).

You can find the presentation, titled “High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study,” by clicking this link.

AXAL is a vaccine approach to treating cervical cancer. To create it, Advaxis genetically altered Listeria monocytogenes bacteria to present HPV-16 protein at its surface.

When immune cells clear the bacteria from a patient’s body, they begin recognizing HPV-16 as foreign and malignant. This triggers an immune response against cancer cells with the protein.

The nine women in the Phase 1, dose-escalation, open-label clinical trial (NCT02164461) had persistent, metastatic, or recurrent cervical cancer that had progressed after previous treatment. Those treatments included chemo, radiation or both. Some of the women took Avastin (bavacizumab) as well.

The primary goal of the trial was to assess AXAL’s safety and tolerability. Secondary goals were to see how the women’s tumors responded to therapy, how long it took for their diseases to progress after treatment, and how the therapy impacted their immune systems.

Researchers administered two dose levels of AXAL that were five to 10 times higher than levels in previous studies to try to find an optimum level for a Phase 2 study. The therapy was well-tolerated at the higher levels, they discovered.

The woman who achieved the long-lasting response to AXAL has been under the care of Dr. Sharad Ghamande, director of gynecologic oncology at Augusta University’s Georgia Cancer Center.

“The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac, [AXAL],” Ghamande, who led the clinical trial, said in a news release. “We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor,” which usually is unresponsive to chemotherapy, she said. Many of these patients survive less than 10 months after treatment, she noted.

Another piece of good trial news was that “we could safely administer the drug at five and 10 times the dose levels previously studied, without any significant toxicity,” Ghamande said.

Eight of the nine patients experienced treatment-related adverse events that were on the lower end of a five-point scale that rates their severity. The grade 1 and 2 events included nausea; chills; fever; vomiting; hypotension, or very low blood pressure; and tachycardia, or abnormally rapid heart rates.

One patient experienced a grade 3 level of hypotension. No grade 4 or 5 adverse events were reported.

Advaxis will start a Phase 3 clinical trial evaluating AXAL in women with high-PRmCC in coming months.