Not under the new definition for GBM. First of all, if you understand Dr. Liau’s historical position on IDH mutant tumors, she really didn’t think they were GBM. Secondly, when she made that “everyone” statement long ago, the small percentage of IDH mutant in the trial (if any), would need more time to evaluate longevity, because their median pfs and os is inherently longer than GBM (as now defined) anyway.
With that in mind, just take GBM as now defined. Her “seems” statement back then was not meant to be precise, because, as we know from the survival chart, not everyone are living longer, but enough are living longer that a lengthier trial was needed to delineate true response with what they were observing, which undoubtedly frequently included initial immune response and, in many cases, psPD, as opposed to true progression in patients with true GBM as now defined.
This response would have been more clear to regulators if their firewalled departments studied what was happening untethered from blinds, yet, for statistical standards (to avoid bias), unable to stop early.
Dr. Liau’s long crusade to more accurately redefine GBM by demonstrating, morphological, molecular and surgical differences eventually won over regulators, and, from the little I’ve seen, former intellectual rivals.
This progress in GBM definition and targeted therapeutic treatment thereto, was ironically enhanced by the observed failure for once thought competitive therapies, and even the dubious “success” of a device that took advantage of the antiquated GBM definition, and people’s prior ignorance regarding the ability to front run and then not truly follow through with long term follow up. The consequence was that DCVax-l even had a longer road, because they needed to await competitive trial failure in some therapies and the exposure of poor trial design in a device.
With all those things finally having occurred, and GBM now redefined to a status that should, by all outward appearances, demonstrate a significant response to DCVax-l, we should be able to move forward into a new era of very safe and more effective natural therapies strengthening and leveraging the patient’s own immune system.
