(Updated from May 27 at 6:07 pm ET)
The tumor response rate attributable to Northwest Biotherapeutics (NWBO) DCVax-Direct is zero. None of the 19 patients with advanced, metastatic cancers have responded to treatment with DCVax-Direct in an ongoing phase I clinical study.
Perhaps you're confused by Northwest Bio's glowingly positive DCVax-Direct press release issued Tuesday morning, or CEO Linda Power's conference call after Tuesday's market close in which she reiterated how well desperately sick cancer patients were responding to the company's magical dendritic cell soup.
Well, you only have to let Powers speak for 20 minutes or so before the truth comes dribbling out. On her conference call, Powers acknowledges the best response seen so far following DCVax-Direct injections directly into a single tumor was 28% shrinkage. Under the globally accepted definition of tumor response known as RECIST (Response Evaluation Criteria in Solid Tumors), a partial response requires a 30% reduction in the size of the target lesion.
DCVax-Direct: 0% response rate.
Keep spinning, Linda! There are more cancer patients with little hope who need to be exploited. The "Naysayers" will always be here to unpack the truth.
Wednesday update: Powers, on last night's conference call, conjured up a false and misleading comparison between DCVax-Direct and the cancer immunotherapy "checkpoint inhibitors" being developed by Bristol-Myers Squibb (BMY - Get Report), Merck (MRK - Get Report) and other large drug companies. I'm paraphrasing her words, but Powers claims the 50% response rate observed in the DC-Vax Direct phase I study to date is greater than the 25% response rates seen when checkpoint inhibitors are used as monotherapy, and even better than the 40% response rates for checkpoint inhibitor combination therapy.
Excuse my language, but Powers is spewing bullshit. Bristol's nivolumab and Merck's MK-3475 have shown to be remarkably effective at shrinking tumors and prolonging survival in patients with advanced melanoma, lung cancer and other solid tumors as both monotherapy and in combinations. I've already written about some of the checkpoint inhibitor data which will be presented in more detail at the upcoming American Society of Clinical Oncology (ASCO) annual meeting. Over the weekend and on Monday, even more impressive results from these drugs will be announced.
For Powers to compare the unconfirmed, anecdotal and faux responses to DCVax-Direct to the real and profound efficacy seen from checkpoint inhibitors is completely irresponsible and absurd. But like most of her actions, Powers' motivation is stock promotion, not helping cancer patients. Northwest Bio would rather issue press releases and hold conference calls for ignorant retail investors than present real clinical data at a respected medical meeting like ASCO. Northwest Bio didn't submit any of its DCVAX-Direct data for peer review and presentation at ASCO. Instead, the company bought a booth in the exhibition hall, where it can give away free pens to anyone who happens to walk by.
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