Northwest Biotherapeutics (NASDAQ:NWBO)
- NWBO issued an update regarding their ongoing phase 3 trial of DC-VAX-L in Brain Cancer
- Company safety hurdle met, but efficacy analysis still pending
- Efficacy analysis is way overdue at this point
Details
NWBO issued a press release this week. The title of the PR sounds great: "NW Bio Receives Recommendation to Continue with Phase III GBM Brain Cancer Trial Based On Data Safety Monitoring Board’s Safety Review"
But a careful read of the press release reveals some oddities:
The company states that the company:
announced today, in response to shareholder inquiries, that the Data Safety Monitoring Board (DSMB) has made an unblinded review of the safety data for the Company’s ongoing international Phase III GBM Trial, and has recommended that the trial continue as planned
How's that again? Back on December 10th the company stated that the interim analysis would take 6 to 8 weeks. Now, 12 weeks later, the company says the PR is "in response to shareholder inquiries"? That doesn't sit right with us.
Efficacy Review Still Pending - Red Flag
The March 7th press release goes on to state that:
The DSMB’s review of the efficacy data is still pending.
Hmm. Let me get this straight - the DSMB has been at this for 12 weeks, and has only managed to analyze the safety data enough to say the trial can continue, but the efficacy review is still pending? This does not pass the sniff test. In a cancer therapy trial against a placebo comparator, the only way the trial would be stopped for safety is if the active therapy was actually harming patients. It's absolutely no surprise that re-injecting patients' own dendritic cells back into their bodies is not causing alarming safety problems.
So this means that the DSMB has not yet looked at the progression free survival (PFS) rates in the treatment arm VS. the placebo arm. - That's what is meant by the efficacy analysis being pending.
Based on NWBO's past statements regarding their phase 1 trial of DC-VAX-L, the therapy should be providing median PFS of 2 years compared to median PFS of 6 months for a "matched historical control". If the therapy really worked this well - it would be readily apparent with just a cursory review of the interim data.
Recall that Immunocellular Therapeutics (NYSE:IMUC) recently announced that their therapy for brain cancer showed only a 2-month PFS advantage over placebo.
Red Acre Takeaway
Given the long delay in providing interim results, and no announcement of efficacy data, our view is that the efficacy data are most likely not too stellar. We are not at all surprised that the trial will continue since this interim analysis was after only 60% of the events needed for trial completion. Just as with IMUC, we believe that NWBO's phase 1 trial overstates the potential benefit of DC-VAX-L due to a hand-picked patient population that was predisposed to survive regardless of the efficacy of the therapy. For the sake of the GBM patients we sincerely hope we are wrong about this. We are on the sidelines for NWBO.
