Advaxis Begins Phase 3 Study of AXAL for Advanced Cervical Cancer

Advaxis Begins Phase 3 Study of AXAL for Advanced Cervical Cancer

Advaxis has begun its Phase 3 clinical trial evaluating axalimogene filolisbac, or AXAL, administered in the adjuvant setting following chemotherapy and radiation in women with high-risk, locally advanced cervical cancer.

AIM2CERV is a muticenter, randomised, placebo-controlled Phase 3 clinical trial (NCT02853604) designed to compare the disease-free survival (DFS) of AXAL to placebo administered following concurrent chemotherapy and radiotherapy (CCRT), as adjuvant treatment for high-risk locally advanced cervical cancer with curative intent. Participants are being recruited for the clinical trial.

In the trial, according to an Advaxis press release, up to 450 patients will be assigned randomly to receive either AXAL or placebo every three weeks for three doses for the first three months; afterward, patients will be treated with AXAL every eight weeks for five  doses or until disease recurrence.

Trial secondary endpoints include the safety and tolerability assessment, overall survival, as well frequency and severity of adverse events, measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). The trial is being conducted in collaboration with the GOG Foundation, now part of NRG Oncology.

AXAL is a new vaccine approach that uses the live attenuated bacteria Listeria monocytogenes genetically altered to present the HPV-16 protein at the surface. The protein is then recognized by T-cells, which will become specific to HPV-positive cancer cells.

A Phase 2 clinical trial of AXAL with or without Platinol (cisplatin) chemotherapy has been completed. This trial included Indian patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix, and the results demonstrated an overall survival rate of 32% at 12 months, as well as acceptable tolerability.

AXAL also is being evaluated in a two-stage Phase 2 clinical trial, GOG-0265 (NCT01266460), in patients with PRmCC who have failed at least one line of therapy. In Stage 1, treatment of 26 patients with AXAL resulted in a 38.5% 12-month overall survival rate, the company reported in October. In stage 2, there was a 42% six-month overall survival rate, and a 67% six-month survival rate in 12 patients who received three or more doses of AXAL.

AXAL is being evaluated in three additional ongoing studies in HPV-associated cervical cancer, either as monotherapy or in combination with other immunotherapies, such as MedImmune’s durvalumab.

In July, the U.S. Food and Drug Administration (FDA) granted the Company a Special Protocol Assessment for the AIM2CERV trial. In addition, AXAL was granted fast track designation by the FDA to treat high-risk locally advanced cervical cancer following surgery to remove the tumor, and was granted orphan drug status to treat invasive cervical cancer.

Advaxis also announced the commencement of Part B of its Phase 1/2 clinical trial (KEYNOTE-046, NCT02325557) evaluating ADXS-PSA, in combination with Keytruda (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). In Part A, treatment with ADXS-PSA alone was found to be safe, with no dose-limiting toxicities, across three dose levels tested. More information about this study can be found here.

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