Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

Hey peke, certainly these data look encouraging. I think the biggest red flag we have to consider with this chart is the N. 8 patients had ≥50% drop in part B, with no events (as you indicate) after approx 12 months.

Possibly this does mean something like a doubling of the OS, but with just 8 patients, the uncertainty is very high. Therefore, you probably won't see any formal statistical comparisons performed between <50% and ≥50% cohort. It won't say much.

It IS, however, an encouraging signal that somethings going on with the treatment. Whether that's related mainly to pembro or the combination of ADXS-PSA and pembro remains to be determined. We do know that it looks kind of like more patients had a >50% drop in the ADXS study, but it also appears that pembro alone (in KEYNOTE-199) was given in patients with higher basline PSA, meaning it's not an apples to apples comparison.

Long story short: yes it could mean that part B (>50% drop) will exceed the median OS of part A by a wide margin. Without confirmation in a larger study, this distinction may not be meaningful other than to be rather interesting.

Hopefully we get further clarification soon!