NorthWest Biotherapeutics Inc (NWBO)

[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.