NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

The NWBO DCVAX-L for GBM phase-3 had a primary endpoint is progression-free survival (PFS), with overall survival (OS) as a secondary endpoint. The only end point in any trial is overall survival. Other endpoints are often chosen if it is believed they can convince the regulatory agencies that they are an indisputable indication that overall survival will improve in this case because progress free survival (the tumor decreased in size) means patients will live longer. If they only use overall survival then they have to wait years and years as NWBO did to prove overall survival increased. Unlike most chemo treatments that immediately shrink tumors we now know that tumors can actually enlarge initially due to the infiltration of immune system cells that work to kill the tumor. Progression-free survival (PFS) is not always a valid endpoint for immunotherapy trials because immunotherapy can sometimes cause tumors to initially increase in size before shrinking, a phenomenon called "pseudoprogression," which can lead to misinterpreting actual treatment efficacy based on tumor size alone, making PFS unreliable as a sole measure of treatment benefit in such cases; the gold standard for evaluating immunotherapy efficacy often remains overall survival (OS) instead . . . but you know all this far too well EX. Why are you again trying to mislead?