NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

We know that because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L.

232 patients of the treatment group and 66 patients of the placebo group = 298 patients who received DCVax-L (90% of 331 ITT population)

I don't believe that a majority of the 66 are pseudo PFS placebo cross-over patients, maybe a few.

Te authors of this scientific article, published online February 21 2019, seem to think otherwise.

Current State of Immunotherapy for Treatment of Glioblastoma.

Tresa McGranahan, MD PhD, 1 Kate Elizabeth Therkelsen, MD,2 Sarah Ahmad, MD,2 and Seema Nagpal, MD2

DC-Vax-L uses whole tumor lysate to pulse patient-derived DCs. Currently over 10 years from diagnosis, some of the patients enrolled in the original phase 1 study of this vaccine are still alive [43]. The phase 3 of DC-Vax-L in newly diagnosed GBM results is still blinded; however, recent reports described a mOS of 23.1 months for all participants (90% of whom received the DC-Vax-L treatment due to crossover design).
While the data remains blinded, there are concerns that this may only be interpreted as a single-arm study of 331 patients due to cross over as a result of pseudo-progression and not true progression [44•].

Again promising are reports of durable responders in the phase 3 with survival exceeding 7 years. This vaccine is also being studied in a phase 2 clinical trial in combination with the PD-1 inhibitor, nivo (NCT03014804).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394457/