Replies to post #540785 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Not much here that we haven't heard before. It will fade away.

[lutherBlissett]

i love this guy hopefully tweeting at the The Brian Tumour Charity with his concerns...

Dr David Jenkinson, Chief Scientific Officer at The Brain Tumour Charity, said:
“This is a landmark and long-awaited breakthrough in the treatment of glioblastomas. It’s extremely exciting that adding this personalised vaccine to chemotherapy has been found to be able to offer nearly three precious extra months to live and spend time with loved ones to those diagnosed with the most aggressive form of brain cancer.

“With so few effective treatments available, average survival for the thousands diagnosed with a glioblastoma each year in the UK has for years remained heartbreakingly short at just 12-18 months. So it’s absolutely fantastic news that, following years of research and innovation, the first new systemic treatment able to offer life-extension to glioblastoma patients in over fifteen years has been found, and that it is effective in both newly-diagnosed patients and those with a recurrent tumour."

[flipper44]

These are all clinical oncologists that actually specialize in radiotherapy and/or radiosurgery.

DCVax-l long term survivors typically do not have recurrences and therefore do not need repeat RT and RS.

The RT/RS specialists have conflicts, they just don’t know it.

[CherryTree1]

These doctors must not have read the journal article because all their concerns with the external control group used are addressed in detail and were vetted by independent experts.
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma
A Phase 3 Prospective Externally Controlled Cohort Trial

External Control Populations
The ECPs were determined by an independent expert firm (York Health Economics Consortium) and comprised patients from the control groups from contemporaneous RCTs closely matched to the current study based on 14 criteria prespecified in the SAP (Supplement 1). These studies met the “fit for purpose” criteria outlined by Mishra-Kalyani et al.8 We compared the treatment groups of the external trials to the ECPs to validate the methodology, applied sensitivity analyses to check for biases, and conducted a matching-adjusted indirect comparison (MAIC)18 to adjust for imbalances in individual patient characteristics (eAppendix 1 in Supplement 2).

From Supplement 2
Adjustment for Individual Patient Characteristics in ECPs
A fourth set of analyses was conducted to adjust for differences in the individual patient characteristics in the DCVax-L
cohort vs. the ECPs.
This matching was done on the characteristics of age, sex, race, MGMT methylation status, and KPS score, combined with
one of either extent of resection or with residual disease.

Supplement 1
https://cdn.jamanetwork.com/ama/content_public/journal/oncology/0/coi220066supp1_prod_1668698380.81699.pdf?Expires=1672828858&Signature=DAgIIBtNfhl5N7i6-5lNEwEmzoJ3E14rtW8DqSa0Y59KT1kN~VQxT8GCs2KOEEHW6f1-4geYiMndU-oPw3lL3DaRG52ArYY-3y6AXRijVNPvyJ2Vn9G4UHSGnOoOVO4eb1jcDas8-b-ntwyt4CAVNoVHby0qGaE0Ld3Zbb~B4ZpYulq9QHD0utU4rJNT6op6rsQCA31df8dUYGilXSkQRqk0R30zWjCiXt~RpER80N8LEWhs~jlrdVs5Kg3-GLdSxS6d32Hvc58YphffZ1KZ07GXw1OBii3gCtb14ciyILbTS~aLAD6BemrJlWCTjubaMBfMbLEBopBnSm8jCS6U2w__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA

Supplement 2
https://cdn.jamanetwork.com/ama/content_public/journal/oncology/0/coi220066supp2_prod_1668698380.82197.pdf?Expires=1672828858&Signature=2W~XPVfyBeTaQeumZg6KbGgMfPbZD5poJJmzpwzcQ88GZtALfq7PhDoh-rj20zJKpOPn3a84vprerAIev66R-UujOkRJi8hzMMTx2Ii4g5MQsmTLd7euxLoAdziLc1adU9HMtZlfZKrPOx3tWJrXthUIksW-z38Y2xMabJ35keTLcNa39jAyyI29IIrThMJSXiYa01StUnsjM3FsKjT8Hf8GiWOD6EGnEKtm3ukC4CvzoD8Usd9oAwffk2DPp2w1FnATSjeppOyZpSd5y5liQSExzs533qRvxliNQa-AHuTQiGO4EfWk-mNZJlCwyAmLmu3K66GENVHhwRneqQhpcA__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA

[Red_Right_Hand]

This is irrational. If there is evidence of general improvement in OS in trial-enrolled GBM patients, then this general improvement would be observed not only in the treatment arm as the commenters conclude, but would also be seen in the ECA that was used (because all ECA patients were trial-enrolled GBM patients), as well as in the "comtempeaneous randomised controls" (sic) that are proposed by the commenter.

In addition, there is evidence of general improvement in OS in patients with GBM enrolled in trials: for example, the median OS in the control studies for patients with MGMT methylated GBM receiving chemo-radiotherapy with Temozolomide is quoted as being 21.3 months; we note that the recent NOA-09 study had a median OS of 31 months in that same group of patients, emphasising the importance of using data from contemperaneous randomised controls. The general effect is these would be to increase the survival rate in the trial arm, irrespective of the effect of DCVax.

[iclight]

Can we put this list of actual cancer doctors, in the chart of doctors NOT convinced by these results?

Dr. Matt Williams, London
Dr. Paul Sanghera, Birmingham
Prof. Susan Short, Leeds
Dr. Anup Vinayan, London
Dr. Juliet Brock, Oxford
Dr. Chris Herbert, Bristol
Dr. Joanne Lewis, Newcastle
Dr. Shaveta Mehta, Liverpool

And perhaps remove the non-cancer doctors like ER doctors and Foot doctors in the column who think the results were positive?

[dr_lowenstein]

right on Matt!!! et al LOL LOL