NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Crossover becomes open label. Hard to believe with all the analysis previous data can remain blinded but maybe??

>>Additionally if patients in either cohort develop tumor recurrence at any point during the trial, they will then have the option of receiving DCVax®-L following a specific process that crosses them over to the IMP arm. From this point onwards subjects will be in the open label follow up arm, but without unblinding the previous trial data.



PFS seemed just fine in Pl&ll so why abandon in Plll?

>>For patients with ND-GBM, who received DCVax®-L in addition to standard of care treatment, progression-free survival (PFS, as evaluated with use of the McDonald's criteria) was around 24.0 months and OS was 36.0 months.29

The long-term data analysis (last updated in July 2011) showed that 33.0% of patients had reached or exceeded a median survival of 48.0 months and 27.0% had reached or exceeded a median survival of 72.0 months. By year 2013, two (n = 2) of the Phase I/II clinical trial patients were still alive reaching a survival of more than 10.0 years.


>>Despite advances in standard of care and adjuvant therapy, GBM prognosis remains poor with a mean OS of 14.6 months- for ND-GBM and a mean OS of 7.4 months

https://www.tandfonline.com/doi/full/10.4161/hv.29276