Replies to post #764308 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

x,

Thanks for offering us your brilliant analysis, but you’re not a doctor 😶



The statement made by the unnamed commentator regarding the trial and the efficacy of DCVax-L is not supported by the published findings and is factually unfounded. A peer-reviewed study published in JAMA Oncology thoroughly examined the use of DCVax-L in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM), demonstrating significant improvements in overall survival (OS) compared to matched external controls.

Specifically, for patients with nGBM, the treatment with DCVax-L combined with standard of care (SOC) resulted in a median OS of 19.3 months, compared to 16.5 months in the control group. In the case of rGBM, the median OS was 13.2 months with DCVax-L, compared to 7.8 months in the external control cohort. These results were statistically significant (p < 0.05) and indicate a clinically meaningful improvement in survival.

The commentator’s claim that the survival in the treatment group did not exceed that of the control group is clearly contradicted by the study’s findings. Furthermore, the critique regarding the use of crossover as an explanation for failure is misplaced. The trial utilized a well-established external control methodology, and the results still showed a significant survival benefit. The use of external control data is a valid approach in oncology when randomized controlled trials are not feasible, particularly in a disease with the poor prognosis seen in glioblastoma.

Additionally, the suggestion that the analysis plan was altered after the trial endpoints failed is misleading. There is no evidence in the published study to suggest that the analysis plan was changed post hoc in a way that would undermine the integrity of the results. The statistical methods employed in the study, including the use of external controls and adjustments for confounding factors, were robust and appropriate for the trial design.

The commentary’s criticisms of patient selection and the external control approach also lack foundation. The external control cohort was rigorously matched to the treatment group on key clinical variables, and the data from this cohort were contemporaneous, strengthening the validity of the comparisons.

In conclusion, the claims made by the unnamed commentator are without merit and fail to account for the rigorous methodology and statistically significant findings of the JAMA Oncology study. The evidence clearly supports the efficacy of DCVax-L in improving survival for patients with both nGBM and rGBM.

JAMA Oncology DCVax-L

Interview with Linda M. Liau, MD, PhD, author of Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma, in a podcast with @JackWestMD. https://t.co/POEeEg5cVz

— JAMA Oncology (@JAMAOnc) November 18, 2022

https://braintumourresearch.org/blogs/research-campaigning-news/astonishing-results-for-brain-tumour-vaccine-trial













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