RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:At least give us news about no news ...One more reason to confirm possible efficacy of the phase Ia, even in March or April, is that as soon they can confirm significant efficacy in as many patients as possible, the easier it will be recruit patients for phase Ib. So the hope for efficacy in phase Ia is not only to see the SP go up in the short term. It is to help the whole program go forward at a faster pace with more money to speed things up, and faster and easier recruitment of patients. Cancer patients running out of options are willing to try new treatments, but if the probability of success is real, it makes the decision to try it easier to take.
jfm1330 wrote: One way they could deal with comminications about the phase Ia is to come out with the news when they will have the MTD, and give any solid efficacy data they have at that point, and give an update on these patients two months later, independant of what is going on with the phase Ib.
juniper88 wrote: Treatment is given every 3 weeks until progression or ifvthere is too much toxicity. Up to 18 months. Progression is determined by CT Scan.
jfm1330 wrote: I did not see any specific info on that, but my understanding is that they will continue to treat a patient with the drug as long as there is a percieved benefit. I think that ethically it is the way it must be done.
SPCEO1 wrote: Actually, I think we agree. You restated what I was saying as best I can tell. In phase 1a, do we know how many cycles they are giving the patients? I am not sure depsite having listened to everything very closely over time. But maybe I still missed it and they are doing at least three cycles. At times I thought that but I am no longer sure they are doing more than one or two. It would be nice to have that cleared up.
jfm1330 wrote: I don't agree. Preliminary indication of efficacy is after the first cycle of treatment. Efficacy, or confirmed efficacy, is after several cycles of treatment. The time factor is important when assessing efficacy. You need to see it over time. After a single treatment, the tumor shrinkage can be too small to be sure it's real efficacy. Radiologists will tell you that from scan to scan, some tumors can move, and just the angle of it can make it look smaller or bigger within a 10% range. That's why a partial response is considered to be 30% size reduction or more. You are unlikely to have 30% shrinkage after a single cycle of treatment.
- Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- https://www.verywellhealth.com/partial-response-pr-2252162
SPCEO1 wrote: I
One thing I have been thinking is that we need to listen to their words closely. When they say "preliminary indications of efficacy" I think they are talking about phase 1a and when they just say "efficacy", I think they are talking about phase 1b.