Well, if many of here still feeling reading that 6% ORR is a bit...

Extending from my earlier post and Hodgie's post, yes, that ORR is calculated as the patient with complete or partial responding. ORR is more related to the 'curing' of the disease and this will be more associated to the readout of progress free survival by the end.

In this case, the part B of TACTI002 reported here is the 2nd line treatment, with patients from PD1 refractory. Just imagine, these patients are not anymore able to treated by chemo, surgery, and even the last resource of the PD1 drug is not helping, how hopeless they are in that kind of position.

So in this kind of setting, the other readout of disease control rate is more important. DCR is calculated by the patients that having disease stablised and that is more to the extension of 'life' after they are most likely sentenced with a specific time frame of left over of 'life'. This is more associated to the readout of overall survival by the end.

One very important thing about TACTI002 is that this is a all comer PD1 level trial. So for the patients failed in standard PD1 treatment, I believe one of the big reasons would be their low or negative PD1 expression level, and plus whatever hard conditions they have. In this part B of the TACTI002, this is really dealing with the hardest condition in metastatic NSCLC. So any positive outcome would be a big achievement to human medicine.

Here, lets have a retro on the part A of TACTI002.
This was cut from the presentation July last year. As shown, PD1+Efti combo is winning all over against PD1 alone in term of ORR readout.
More importantly, this data was cut off in Apirl 2021, and the overall survival was at 13+months at that time. Up to today, we have not heard about the 'milestone reached' in overall survival, meaning the overall survival today is 24+month today and still extending.
This is already gone passed the historical comparison to PD1 alone of 20.2 month (from my memory, that number should be from Kenote-042 from Merck)


For the Part B here, if by the trial progressing, the ORR is potentially incresed to 15% (from 6% Nov 2021) and DCR increased to 50% or above (from 36% Nov 2021), which is very realistic. If that happens, such Ph2 readout is already a very big milestone for the field and I can't see why FDA is not giving them another fast track on NSCLC.

Well, if many of here still feeling reading that 6% ORR is a bit itchy, there is a piece of news came in just in the perfect timing.

Patients with renal cancer failed on immuno checkpoint inhibitory treatment (most likely PD1, but not sure whether is Keytruda, will check later), then on this 4D pharma plus Keytruda combo, 4 out of 20 stablised the disease for at least 6month, that is converting a DCR of 25%, hitting big milestone for them.