NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

Sorry, NWBO dropped the PFS primary endpoint because the FAILED TO MEET IT and that was a disaster for them.
They did an informational trial to assess PFS and reported it in 2015:
"20 Rapid-Progressor Patients: Patients with a new lesion ≥ 1 cm. in size, or tumor growth of ≥25% both at a Baseline Visit and at Month 2 thereafter;
25 Indeterminate Patients: Patients with evidence of progression at the Baseline Visit (rendering them ineligible for the trial), followed by stable disease, modest progression and/or modest regression (or unclear tumor measurements), neither of which is enough to classify them as either a Rapid-Progressor or a Pseudo-Progressor;
1 Pseudo-Progressor: A patient whose Month 2 image showed resolution of most of the prior appearance of tumor growth that had been seen at the Baseline Visit."
From the NWBO data press release -- ONLY ONE PATIENT OF 46 SHOWED PSEUDO-PROGESSION.

In addition, Dr. Liau's 2018 interim analysis documented the commitment to the PFS primary endpoint and expressed confidence in their ability to assess PFS:
"The study’s primary endpoint is PFS, and the secondary endpoint is OS. PFS has not yet been evaluated for this publication and will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon."