NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I don't believe any of the prior presentations had a peer reviewed and accepted Abstract prior to the presentation. If I'm wrong, if in fact an Abstract was revealed prior to any presentation I'd appreciate it if someone would provide a link.

Gary,

THE SOCIETY OF UNIVERSITY NEUROSURGEONS
Prague, Czech Republic
2022
ANNUAL MEETING
June 29th-July 3rd, 2022
Abstract

Autologous tumors lysate-loaded dendritic cell
vaccination in patients with newly diagnosed
glioblastoma: Survival results from a phase 3 trail

Linda Liau, MD

Glioblastoma is the most lethal primary brain cancer.
Clinical outcomes for glioblastoma remain poor, and
new treatments are needed to improve the prognosis
of patients with this devastating disease. The main
objective of this study was to investigate whether
adding autologous tumor lysate-loaded dendritic cell
vaccine (DCVax-L) to standard of care (SOC) extends
survival.
An international, multi-center Phase 3 randomized,
double-blinded trial with crossover was conducted
in 94 sites in 4 countries (November 2007- 2015),
with follow-up through October 2020. 331 patients
18 – 70 years of age with unilateral glioblastoma
(GBM) whose tumor was resected and had completed
concomitant radiochemotherapy (median time from
diagnosis to randomization, 3.1 months) were enrolled.
Synthetic control arms were comprised of 1,366 newly
diagnosed GBM (nGBM) and 640 recurrent GBM (rGBM)
external control subjects from contemporaneous
randomized controlled trials that were independently
identi!ed based on pre-speci!ed criteria.
Patients were randomized 2:1 to DCVax-L plus
maintenance temozolomide chemotherapy (n=232)
or placebo plus temozolomide (n=99). The majority of
placebo patients crossed over to receive DCVax-L at
the time of recurrence. 232 received DCVax-L following
original diagnosis, and 64 placebo patients received
DCVax-L following disease recurrence. At the time of
recurrence, patients received SOC physician’s choice,
lomustine or bevacizumab.
The primary and secondary endpoints compared
overall survival (OS) in nGBM and rGBM, respectively,
with the external controls. Four sets of analyses were
conducted to con!rm rigorous matching, reduce/
eliminate known and unknown potential biases, and
con!rm the robustness of survival results. Median OS
(mOS) for nGBM patients (n=232) was 19.3 months
from randomization (22.4 months from surgery) with
DCVax-L vs. 16.5 months from randomization in the
external controls (HR=0.80, p=0.002). Survival at 48
months from randomization was 15.7% vs. 9.9%, and at
60 months was 13% vs. <5.7%. For rGBM (n=64), mOS
was 13.2 months from relapse vs. 7.8 months in the
controls (HR = 0.58, p<0.001). Survival at 24 months
post-recurrence was 20.7% vs. 9.6%, and at 30 months
post-recurrence was 11.1% vs 5.1%. In nGBM patients
with methylated MGMT (n=90), mOS was 30.2 months
from randomization (33 months from surgery) with
DCVax-L vs. 21.3 months from randomization in the
controls (HR=0.74, p=0.027). The treatment was very
well tolerated.
In conclusion, the addition of DCVax-L to SOC resulted
in a clinically meaningful and statistically signi!cant
extension in overall survival for both nGBM and rGBM

https://static1.squarespace.com/static/55d34232e4b0a3f1fd2a226a/t/62c6e8fdc8ae1c1cb61ae488/1657202946459/Website+SUN+2022.pdf