Replies to post #134129 on NorthWest Biotherapeutics Inc (NWBO)

[reg2015]

What I think SOS said:

Paper in a few weeks.

0$ to $29.00

Wait till Nov. to un=blind is best

everything could be confounded, but still approved if certain results show that blessed "long tail"

Peace

[BioAddict]

Yeah I was thinking about this last night... The company might be blinded but they know the number of doses given... They would therefore certainly know the number of doses given on a per patient basis.

10 doses (full regiment) = 30 months survival from randomization. You can bank that patient as someone who benefited from DCVax.

9 doses (9/10 regiment) = 24 months survival from randomization. Someone who will help the trial get approved.

They probably also know, patient X got does 9 on X date, he/she is due for does 10 on X date, did they get that dose? With this data the company can most likely piece together the trial results.

They probably are fine on PFS and OS right now and could stop the trial, In one more month all patients in DCVax Arm will have received 9 doses that have not unfortunately passed, in 7 months from now all patients will have received 10 doses.

I don't think they need to wait another 7 months, but I could see wanting to wait a few more months...

From Smiths Article - sounds like we will be getting OS/PFS numbers for the entire study in that paper to date. This must be good news or why publish this information at this time. Clearly wanting to help the company raise money and survive until they can have a mature data set. FDA on board with this I would imagine.

[Smokey21]

I believe that Larry has a couple of errors in his article.

Overall in the trial 90% or more of patients received DCVax-L indicating that 76 or more of the patients who started on SOC were crossed over to DCVax-L and that only 34 or less patients in the trial received only DCVax-L

I believe he meant to say 34 or less received only SOC.

NWBO has decided to let the trial continue in order to have a clear insight into the survival tail. In this trial of 331 patients, the median time of enrollment was May of 2014 and the last patient was enrolled in November of 2014. This means that even the last person enrolled will have three year survival data when the trial is stopped and the data analyzed and most will have far more.

I believe the last patient was enrolled in November, 2015

[Hiawatha16]

He states that they would want to let the trial run 3 years. To me this means November 2018 would be data lock. ?????

[exwannabe]

OK, so SoS is using 2 Opdivo trials to show why NWBO is right to run the DCVax-L trial long. Here are the basic facts:

Checkmate-017 (squamous) :

Enrolled: 10/2012 - 12/2013

PR'd Results: 01/2015

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company will share these data – which for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer – with health authorities.

CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.

Approval: 03/2015 NOTE: This was fast as they had previously submitted the full BLA based on an earlier trial, this trial was an add-on to that


Checkmate-057 (non-squamos N=792) :

Enrollment: 11/2012 - 12/2013

PR'd Results: 04/2015

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus everolimus in previously-treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

“The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival.”

CheckMate -025 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -025 data and work with investigators on the future presentation and publication of the results.

Approval: 09/2015Vax-L

DCVax-L:

Enrollment: 1/2012 - 10/2015 (though some earlier)

Results/Approval: crickets

Summary:

SoS concludes the other 2 trials show why NWBO needs to run the DCVax-L trial well past planned endpoint analysis. The argument is it needs the data. Yet the two comp trials were successful at substantially shorter early stops.