Advaxis’ Cervical Cancer Treatment Trial Shows Progress in Survival Rate
A trial of a cervical cancer treatment by New Jersey biotech company Advaxis demonstrated it could extend life further than existing treatments in women with persistent, advanced forms of the disease.
Among the high-risk patients placed on the immunotherapy therapy axalimogene filolisbac and studied through a one-year period, there was a 38.5 percent survival rate, the company said last week.
Conducted by the nonprofit Gynecologic Oncology Group, the first-stage of the Phase 2 trial monitored how three doses administered over three months influenced the health of 26 patients who had not improved with other treatment options.
Many of the women (73 percent) experienced low-grade safety concerns — mostly fatigue, chills and fever. Four patients had more serious health risks, including hypotension and cytokine release syndrome, and one fell ill with a lung infection and sepsis.
Despite these risks, the data reinforces a separate Advaxis Phase 2 study and signifies progress for treating a deadly gynecological cancer.
Advaxis submitted a special protocol assessment to the FDA for a Phase 3 study to evaluate safety and efficacy of the treatment in high-risk, locally advanced cervical cancer.
Roche’s Avastin was approved last year by the FDA and the European Commission in April as a treatment — combined with chemotherapy — for women with the same type of aggressive cancer. — Victoria Pelham