Hi davybabyk!Regarding the OBD and effectiveness comparison...

Hi davybabyk!

Regarding the OBD and effectiveness comparison between doses, do you think the assessment of effectiveness between doses is mostly about tumor shrinkages and not so much about lymphocyte marker changes?
I view that the effectiveness between patients is quite heterogenous even with the same dose: IT/IV route, different tumors types (organ and cell types + speed of cell growth and metastasis), efficacy of previous therapies, overall immune function, measurement error of CT scan etc. The difference between efficacy has to be enourmous to in order to observe the difference (in tumor shrinkage) with 3-6 patients per each group. If OV manufacturing isn't a limitation between 3e8 and 3e9 doses, I really hope they go to the top of 3e9 if no DLT is seen, which is likely based on preclinical + other OVs that have been given to humans. Also, in many other Ph1 oncolytic virus studies that I read few weeks ago, there was most of the time low to moderate correlation between doses and responses. If OV is inefficient, results are the same regardless of the dose 1e6 * 0 or 1e9 * 0 is still zero.

TLDR: Even for good cancer drugs we need RCT N=100 vs 100 with closely similar patients to judge if the intervention is beneficial or not. How it could be assessed if CF33 doses 3e8 and 3e9 do not have different efficacy with 3-6 heterogenous patients per group?