A recent trial showed the anti-cancer vaccine axalimogene filolisbac, also known as ADXS11-001 or AXAL, to be well tolerated at higher doses, with promising results against persistent or recurrent metastatic carcinoma of the cervix (PRmCC), according to vaccine maker Advaxis.
Results from a Phase 1 dose-escalation trial (NCT02164461) were featured in the poster, “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,” presented at the 2017 National Cancer Research Institute conference in Liverpool, England.
Advaxis, headquartered in Princeton, N.J., has developed an immunotherapy to target HPV-associated cervical, anal and head and neck cancers. This new therapeutic method stimulates the immune system to specifically attack tumor cells. At the same time it neutralizes the tumor’s natural microenvironment protections in order to expose the tumor to an immune attack.
In this Phase 1 study, nine women with persistent metastatic or recurrent, squamous or nonsquamous, carcinoma of the cervix received AXAL injections every three weeks, for a total of 12 weeks. Patients had reported disease progression after receiving chemotherapy or radiation, with or without Avastin (bevacizumab).
To determine the vaccine’s tolerability and safety, PRmCC patients received doses five and 10 times higher than those previously tested in Phase 2 and Phase 3 trials. Six patients received the lower dose tested, while the remaining three got the higher dose.
Doctors observed no significant toxicity, with eight patients presenting mild to moderate treatment-related adverse events such as chills, nausea, vomiting, headache, fever and low blood pressure. Only one patient presented a severe case of hypotension.
Among women receiving the lower dose, none had significant responses during the study. The effects of the higher AXAL dose, however, were more promising, with one patient in stable condition with no further progression, and another experiencing an ongoing and durable partial response for at least eight weeks.
“We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months,” Sharad Ghamande, director of gynecologic oncology at Augusta University’s Georgia Cancer Center, said in a press release. “In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity.”
Advaxis has ongoing trials on effectiveness of AXAL as monotherapy or in combination with standard-care therapeutics for cervical cancer. The company also expects to start a Phase 3 trial in PRmCC later this year.