Ayala Pharmaceuticals Inc (ADXS)

[raja48185]

Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care

Interesting data. Let us see market reaction over the next few days.

<The presented survival data in patients with visceral metastases strengthens our confidence that ADXS-PSA in combination with KEYTRUDA® has the potential to provide meaningful increases in median overall survival in patients with advanced, metastatic, castration-resistant prostate cancer,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Importantly, these demonstrated impacts on survival have not been previously observed with immunotherapy in this advanced patient population leading us to actively assess next steps for the program with the hope of providing a much-needed new treatment for these patients with limited options.>

<72.4% (21/29) of evaluable patients showed stable disease

38% of patients had PSA declines and 27% had >= 30% PSA decline from baseline

The combination of ADXS-PSA and pembrolizumab appeared safe and tolerable in this heavily pretreated, unselected population of patients with MSI-High-negative mCRPC

Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy>