Replies to post #252960 on NorthWest Biotherapeutics Inc (NWBO)

[Sojourner55]

This was a question I posed earlier. I hope by dragging out the SAP since January they now have an extra year of data since last SNO that hopefully is sufficient to address the crossover challenge.

what would be legitimate reasons for further accrual and delaying data lock considering the maturity of the trial? Is it possibly due to weaker statistical power due to the last 31 patients randomized to treatment; time needed for adequate separation of crossovers and ....?

but the crossover design makes interpretation challenging and further interpretation as the data mature is vital to assess the efficacy of this approach.

[sentiment_stocks]

Interesting... especially in that it’s coming out of UCSF.

[marzan]

Dr. Bala, thanks for the link. Good abstract. LL said in 2018 most of the survivors were PFS free. In my mind more than half of the pool is A lot. Most means greater than 75%; could be close to 90%. So, like flipper has been telling us the perecentage of patients that did crossover could not be that many at least in the context of the ones that are alive now. So, I think in spite of crossover possibly interfering the statistical strength, this adjudicated PFS strength could standout I believe. You are a PhD mathematician, you know better than me.

[sukus]

Very promising Dr Bala. And especially interesting if this red bold below is replaced with patient own solid tumor. What it would be like when validated. I believe there will be .... in the field of oncology. Imo.

Several vaccine strategies have been attempted, and one that holds promise is DCVax-L, which is a strategy that harnesses a patient's own dendritic cells that have been pulsed with proteins extracted from their own brain tumor from specimens retrieved from resection. The patient's dendritic cells are then reintroduced after they are able to stimulate an antitumor immune response. A phase 3 trial evaluated DCVax in newly diagnosed patients in conjunction with TMZ versus placebo, but allowed for crossover at time of recurrence; preliminary results show promise, but the crossover design makes interpretation challenging and further interpretation as the data mature is vital to assess the efficacy of this approach.

[MalteseFalcon]

Nice find and thanks for posting as it good to see USF coming around. My cousin and her husband lived in Marin and the latter was diagnosed with GBM in fall of 2016. He was a year into retirement after a career teaching in a local high school where he also coached the football team. He went to USF and had his resection and went on SOC. The tumor reoccurred in early 2018 and he died several months later. I spoke to my cousin several times about DCVax and they brought it up with their oncologist. Given the outcome it is almost needless to say that the doctor was not favorably disposed to DCVax. My cousins mother (my aunt) also died from a GBM in the early '80's and her sister (my cousin) died from ovarian cancer in 2015. One wonders if DCVax was available how much tragedy would have been averted.