Biotech Values

[DewDiligence]

ADXS submits MAA for AXAL in second-line cervical cancer:

https://www.businesswire.com/news/home/20180213005807/en/Advaxis-Submits-Conditional-Marketing-Authorization-Application-Axalimogene

The MAA 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%.2 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.

The MAA seeks EMA conditional approval (similar to FDA accelerated approval) that will require validation with subsequent clinical data.