Due Diligence on the short case for VBLT and my response: Part one.
Twitter has a feature you can isolate your search for $VBLT to those you follow. I did such a search on VBLT with an assortment of folks who were negative on VBLT... isolated my people following to just those people and searched.
The response was more scoff... this is bs.... one lady for example Sally Church who edits an oncology news letter said of the ovarian data.... that the sample size was too small i.e. 9/15 of the patients who had a reduction of CA-125 of greater than 50 % might have been a fluke... she went on to say the next 15 patients might not respond at all.
In that same thread of the ovarian ASCO presentation with Sally Church, another said the RECIST data was lacking... i.e. 2 PR and this wasn't on the poster.(It actually was on the poster in graphic form... showing RECIST criteria but not highlighted)
A related meme on the ovarian data set was scoffing at the change between the low dose and the high dose cohorts.... i.e. the PR emphasized the median overall survival difference of 6 months versus 26 months with 4 patients versus 15.... to small of a numbers to be relevant, then from this point, calling into question the entire data set. My response was/is, they may have a point that the first paragraph was questionable and shady due to the small number of patients in each cohort 4 versus 15. But the skeptics/shorts failed to examine the demographics.
AF as I noted on the prior post blasted the CEO as slime and the drug as garbage. Nuff said! Then he pointed out the censoring to the left of the median. But I believe this was a spurious read of the data since many of the patients are alive. The median overall survival of platinum resistant ovarian cancer is about 12 months give or take. But the VBLT data set had a very very sick data set. 50 % of patients never responded to platinum... they weren't just platinum resistant and then stopped responding, but they never responded(as noted on the poster)... another 50 % of patients in the demographics never responded to Avastin. That is a very sick population, as the CEO described them on a prior conference call as 'dying patients'.
So, I think the skeptics/shorts blasted the companies emphasis on survival data based on the small cohorts, but then failed to really look deeply into the data. I have. Take another look at the RECIST graphs for the ovarian data set on the poster.... 2 patients were partial responders surpassing 30 % in tumor reduction, but then another patient is at about 29 % or so and yet another patient went well passed 20 % in tumor reductions or 4 of the 15 patients had 20 % tumor diameter reduction or greater in the high dose arms versus 0 out of 4 in the low dose arms. Also of interest to me and of greater import, the patients with the biggest tumor reductions were also the the largest responders with CA-125 reduction. A final point, beyond the 4 patients on the RECIST graph, a few additional patients had quite stable disease as well. I don't know enough about the demographic characteristics and expected stability of the RECIST graphs to weight this piece of evidence.
Finally on ovarian, many skeptics, scoffed at the companies highlighting the CA-125 reductions as just 'biomarker data'. But if you examine in detail the import of CA-125 in ovarian cancer as I have, although CA-125 in not an exact science, reductions in CA-125 are indicative of a clinical response to treatments, both in the initial and refractory setting. There is not doubt in my mind that a reduction of CA-125 of greater than 50-60 % in significant... not in terms of FDA approval, but in terms of a clinical response to treatment that I have gleaned from reading numerous review articles.
