Though the FDA hit its studies with a clinical hold last year, which it lifted after two months, small cap Advaxis ($ADXS) has posted some updated topline data to back up previous reports that its new med can help some patients make significant gains in overall survival rates.
The midstage GOG-0265 trial was looking at its cancer vax axalimogene filolisbac in patients with persistent or recurrent metastatic (squamous or nonsquamous cell) carcinoma of the cervix.
Its med was put under a clinical hold last year, however, prompted by the death of a patient with end-stage cervical cancer. But the hold was lifted a few months later after the death was attributed to the disease and not the drug.
This, however, had the effect of hitting the makeup of its studies. The GOG-0265 study was originally set up as a single-arm, open-label test to look at safety and activity of the cancer vax in a two-stage design.
The first stage of the study, with data already reported, included a six-patient safety run-in and enrolled 26 patients. This has hit its targets, allowing the test to move on to the second stage.
For this next part the biotech enrolled 24 patients but then got hit by the clinical hold, stopping the second stage from being completed.
But Advaxis dug down into the data it has and said today that a preliminary analysis of 12-month overall survival data from the 24 patients enrolled in the second stage, prior to the clinical hold, “showed that treatment with axalimogene filolisbac resulted in a 37.5% 12-month overall survival rate.”
This is similar to the earlier data that showed a 38.5% 12-month overall survival rate in 26 patients in the first stage of the study and came “despite modest differences in dosing schedules between the two stages,” according to the company.
With some more data digging, the biotech said that “Based on protocol defined prognostic factors of patients who enrolled in the study (n=50), a 12-month survival rate of 25% would have been expected. Comparing this 25% 12-month overall survival rate to the 38% 12-month overall survival rate actually observed across the total study population, treatment with axalimogene filolisbac resulted in a 52% increase in the expected 12-month overall survival rate.”
The biotech is hoping to use these numbers to “pursue registrational opportunities in Europe in 2017,” according to Daniel O’Connor, president and CEO of Advaxis, although there was no mention of an FDA attempt, for which it currently has fast-track status as an adjuvant therapy for treating high-risk, locally advanced cervical cancer.
There were, however, some notable adverse events: 15 out of 24 patients experienced a Grade 1 or Grade 2 treatment-related adverse event in the second stage, nine out of 24 patients experienced a Grade 3 event, and two out of 24 patients had a serious Grade 4 event--namely hypotension and symptoms related to cytokine release, the company said.
More detailed data will be presented soon, the biotech promised.
Despite the positive noises coming from the biotech, the markets did not react well first thing, with the company's shares falling sharply premarket by more than 14% on the news.