Cheers everyone. If anyone find this post is of useful for their overlooking of this company and/or biotech stocks, the pleasure is mine.
To answer your questions,
1. The 4th patient event was the only one they can report and by that time, the difference between 14.2m and 8.8m was already a pretty good separation. We are not just looking at a marginal benefit, but a meaningful enough one. I guess the board just decided to push it out by then and let the market know it, rather than waiting to now (we might or might not have the 5th event by now, if not , even better). That is how we get this big round of organic growth. As we only had the 4th event on 23/11/2020, within the 14+13 patient cohort, the mOS at that time would definitely be longer than 14.2m. Later on, we will have 4 more patients adding to Her-Vaxx arm, it is very hard to believe or almost impossible that the later 4 patients under Her-Vaxx treatment all die quickly and that is the only possibility to reduce the final mOS shorter than 14.2m. Therefore, back on 23/11/2020, the mOS was at least 14.2m and up to now, this number should be much longer.
2. The answer can be yes and NO.
For the patients do not respond to the treatment, i.e., the other 50% that reporting here, they definitely will have a poorer outcome if comparing to the 50% half of the ones that respond. So they might follow the pattern of a control group, just might like the Chemo-alone arm.
However, in many of the cases of clinical trials, even the non-responding part of the subgroup, is still out performed over control arm.
The overall responding rate (ORR) is purely calculated based on the clinical observation, like tumor size, disease severity, patients' feedback, etc.
Though, the ultimate readout is set as overall survival for a reason, just simply that the patient is still alive or dead. A lot of the cases, the patients are undergone some internal changes because of the treatment applied, in cellular and/or molecular levels, those kind of changes might not drive the clinical observation to show any difference on the patient, but those changes can MAKE fundamental contribution towards survival by the end. And that is why in all clinical trials, they will do a detailed cellular/molecular profiling on all patients by the end, based on biopsy sampling, autopsy sampling, etc. This is to find out the deep-under reasons of why the treatment is working, if it is working.
So for now, the most important read outs for this phase 2 trial, are continuing to be the mOS and mPFS, with regard to the speaking of alive/dead and quality of life, respectively. As I always think, for the patients with cancer at metastatic stage, mOS is even more meaningful than mPFS. For those patients, a 6 months of extended life, might simply mean the witness of a number of important events for them, graduation, wedding ceremony, the birth of child/grandchild,.........
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