Trawling through all the reports & trying to remember & compare critical values - to help assess relative effectiveness of Cavatak versus Amgen’s T-Vec, is frustrating.
So, I’ve tabulated available data on Cavatak versus T-Vec – together with some parameter definitions.
If others can fill in any blank fields, please post data in this thread – along with info source. Presumably data for many of these will be supplied at ASCO in June 1.
Summary conclusion is: VLA looking very competitive.
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9 Column 10 0 Treatment ► Cavatak T-VecBiovex OncoVex Phase 2 Melanoma. Final data Average results from trials of 40 anti cancer drugs on patients with Stage 3 & 4 melanoma1 Reference ► VLA 30 Jan 2014 VLA. 2 June 2014 VLA29Sept 2014 VLA21April2015 VLA. 30 Jan 2014 Edison Rpt. Aug 2 20132 Parameter▼ As at July 2013 As at Sept 2013 As at Nov 2013 As at Jan 2014 As at June 2014 As atSept2014 As at April 2015 3 % patients demonstrating immune related progress free survival at 3 months after first dose 6018/30 NR 5019/38 NR 50 4 % patients demonstratingirPFSimmune related progress. free survival at 6 months after first dose 358/23 3310/30 3412/35 3514/40 3719/51 38.622/57 38.622/57This is twice the initial target 19 = Durable response rate from Stage 3 trials.?Over what term?? 155 % overall response rate 278/30 NR 249/38 NR 2615/57 28 2816/57 2613/50Ex stage 2 trial 6 1 year survival rate NR NR 569/16 6012/20 63.621/33 7333/45 7536/48 58 7 Response lasting at least 6 months 92%Ex stage 2 results 8 Complete response 20%Ex stage 2 results
IMMUNE RELATED, PROGRESSION FREE SURVIVAL (irPFS)
irPFS = complete response, partial response (more than 30% drop in size of tumours)
and stable disease
So far 22 patients have reached the point where immune-related progression free survival (irPFS) can be measured at six months. This measure of progression free survival is adapted for immunotherapies - where it is accepted that the tumours may initially
continue to grow as the immune response takes effect, which is somewhere between six to 10 weeks in the injected lesion. Responses have been seen as late as nine months after initial treatment in metastatic (non-injected) lesions. In this trial patients
are injected with the CAVATAK virus directly into some melanoma lesions. The minimum goal in this key measure was to get 10 of the (initially planned total of) 54 patients to reach irPFS at six months, meaning that after six months the person's cancer has been held controlled.
% OVERALL RESPONSE RATE
I take it that this is the same as the “Objective response rate”
My take from Edison is that this is measured by the number of patients who have achieved greater than 30% reduction in size of all tumours in the body
Trawling through all the reports & trying to remember & compare...
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