Posted by Michael Wonder on 14 Feb 2018
Advaxis submits conditional marketing authorisation application for axalimogene filolisbac for the second-line treatment of metastatic cervical cancer in European Union
13 February 2018 - The submission is centred around the encouraging results from the GOG-0265 study.
Advaxis has submitted a conditional marketing authorisation application to the EMA for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC).
The submission is built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted,12-month survival rate of 24.5%. More than 50% of treated women in this study had previously received multiple prior lines of therapy including treatment with bevacizumab and subsequently experienced progression of their disease.
