NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,


Thank you for asking!

Yes, the hope is always that PFS aligns with OS and accurately predicts OS. Unfortunately, trial investigators cannot know in advance precisely how well PFS data actually predict OS until OS data are reached.







https://www.fda.gov/media/71195/download


https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30076-6/fulltext

https://www.ncbi.nlm.nih.gov/books/NBK137763/

https://www.eu-openscience.europeanurology.com/article/S2666-1683(22)02684-2/pdf

https://www.fda.gov/media/113423/download

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Regarding the DCVax-L P3, actual PFS was subsequently enlightened by the OS data, but the predictive PFS data were contaminated and therefore the investigators could not use the predictive PFS data as a reliable surrogate predictor of OS. Instead, they had to wait for actual OS data.

Oncologists always attempt to measure and predict PFS as they should. Every cancer trial will seek to predict PFS in advance of OS which of course takes longer to discover and confirm.

OS is the ultimate standard, but you cannot wait until death to begin evaluating whether a cancer drug is efficacious. The physician must evaluate a patient’s response and try to determine whether the treatment is helping.

Today, doctors have better methods for measuring progression, particularly when studying immunotherapy agents which are still relatively new as the emerging field of cell-based science is leading to rapid changes in the understanding of how cancer can be assessed and treated.

The P3 for the DCVax-L cell-based technology spanned many years. If the trial were designed and commenced in 2023, the investigators would appropriately attempt to measure progression and predict survival using the best methods and most current medical knowledge available in 2023, as any cancer researcher would.

Don’t forget to follow the combo trial!

This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt

— JAMA Oncology (@JAMAOnc) February 15, 2023

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