Hi Herro, love your posts. In respect to your concerns on the interim median PFS on Cvac I also pondered as you did that issue and was pleased when Matthew Lehman clarified as follows:
"Immune therapies such as CVac benefit from time, as the patients’ immune system in strengthened over several doses of CVac. Again, we are very excited about the direction thus far and expect that CVac may show increased benefit to patients – both in terms of progression free survival and overall survival as we continue to monitor patients. Our interim data are quite similar to other successful immunotherapies at this stage in development. We have mentioned Provenge and Yervoy, which are FDA approved, but there is also a lot of other research with other products to look at as well."
While the above information tells a story I must admit he had stated a similar thing in the actual 5October announcement where he stated:
"CVac may be expected to confer increasing clinical benefit to patients as observation continues; the immune system takes time to build up its strongest response against tumor cells. Interim progression free survival and immune monitoring data from the CAN-003 trial demonstrate an early profile similar to other successful immunotherapy products to treat cancer such as PROVENGE® and YERVOY".
Also speaking of the IGCS poster presentation, Dr. Goh commented “We are very pleased by the information we are able to share at the IGCS meeting. The initial immune monitoring data are representative of the type of response necessary to mount an effective immune response against cancer. And the trends in progression free survival are very encouraging. This interim dataset is consistent with expectations for a potentially effective immune therapy to treat ovarian cancer.”
Further the announcement stated: Matthew Lehman, Prima’s CEO said: “We believe that the promising CAN-003 data further validate our ovarian cancer program and the CANVAS trial. We will be evaluating the potential to explore CVac in other cancer types that overexpress mucin 1 as well.”
All very reassuring stuff to me. Further confirmation came from Dr Frazer in his clarification of the results whereby he stated:
"Please remember that these are interim results, not the full time score, and we are trending very nicely to have a good delay in disease progression in patients receiving CVac. As one of our analysts has declared, this trend may become more pronounced as the trial moves forward."
Dr Frazer also used the word "excellent" in respect to the safety data.
Lehman and Frazer have expressed confidence imo while pointing out that CANVAS is needed to establish a statistically powered result. I could be wrong but it seems to me that it may be too early to see the best impact of Cvac for the 63 patient trial but it appears that Dr Goh Dr Frazer and Matthew Lehman believe that time may show a more significant result because of the way Cvac works. I would hope they they would not have used words such as excited and excellent were that not the case.
Just my very ordinary opinions and observations. Looking forward to your future informative posts.
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