Replies to post #683209 on NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

LIAR

5. Conclusions
This innovative vaccine is undoubtedly promising; therefore, the methodological issues of the DCVax-L trial deserve our attention and, possibly, another confirmation trial.

Several changes have been made over the years (replacement of a randomized design with a synthetic control arm, removal of PFS as the primary endpoint, addition of a new study population, conduct of unplanned analyses), raising many questions about data interpretability [60].

Although we understand that the development of personalized vaccines is a complex and expensive process, the limitations of this trial reduce the reliability of the results and prevent drawing firm conclusions about the efficacy of the dendritic cell vaccine.

**** To confirm the results of DCVax-L, it would be ideal to design two new trials, one in the newly diagnosed GB setting and another in the relapsed-disease setting, both randomized, for comparison with the standard of care.***** For example, it could be proposed to conduct a new randomized trial in the setting of recurrent GB, comparing the standard of care (lomustine) with the combination of DCVax-L plus an immune checkpoint inhibitor (PD-1/PD-L1 blocker or CTLA-4 inhibitor) as a strategy for boosting anti-tumor immune responses [28]. As expected in phase III trials, the primary endpoint of the study should be OS; secondary endpoints of the study should be PFS, quality of life, and patients’ reported outcomes.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296384/

[drugrunner]

lol in the 70-80-90sss the fda approved drugs based on MECHANISM OF UNKNOWN ORIGIN …

now they have become more exact in knowing how a drug works …

DCVAX works And will be approved soon