10 July 2018 - Advaxis today announced a clinical update.

Advaxis plans to withdraw its conditional marketing authorizstion application in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy.

Advaxis’ regulatory action in Europe is based on EMA feedback following its initial review indicating the application will likely need additional data to support a conditional approval. The February 2018 submission included data from the Phase 2 GOG-0265 study in 50 patients, which showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with persistent, recurrent or metastatic carcinoma of the cervix, representing a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate was unprecedented when compared against historical data.

Read Advaxis press release