Ayala Pharmaceuticals Inc (ADXS)

[James salmon]

From Abstract - Conclusion;



• The combination of ADXS-PSA and pembrolizumab appeared safe and tolerable in this heavily pretreated, unselected population of patients with bone-predominant mCRPC
– Treatment-related adverse events were mostly Grade 1-2 chills/rigors, fever, hypotension, nausea, and fatigue
– No additive toxicity was observed with the combination therapy
• Although these data are from a single-arm study, the combination of ADXS-PSA and
pembrolizumab appears to show activity and to be associated with prolonged OS in this population
– Median OS (95% CI): 21.1 months (16.0–not reached) in this study population including patients having failed chemotherapy for mCRPC and chemotherapy-naive patients
– Survival benefit was seen regardless of PSA decline
– 59% (22/37) of patients had stable disease/disease stabilization
– 40.5% (15/37) of patients had PSA declines; 16% (6/37) had ≥50% PSA declines from baseline; all 6 patients with ≥50% PSA declines were still alive at data cutoff
• There is a broader immune stimulation in the combination arm (which includes B-cell activation) than in ADXS-PSA monotherapy
– Correlative immune analyses show T-cell responses against PSA (75%) and antigen spreading (85%) in most patients in the combination arm