AACR in 9 days? ORR data on 20+ patients is possible. If enrollment was at a rate of 10 per month by the end of the year then based on company enrollment updates around that time, there would be perhaps 25 enrolled by mid january. weren't there 23 in early january? assuming an 8 week 1st scan (fairly standard, 2 cycles of the SOC in this case), and then a confirmatory scan for ORR 4 weeks later (minimum 4 week interval required), then they could have ORR data for those patients in time for AACR.
SOC drugs have side effects that can cause dosing delays and thus scan delays, and in most trials a few patients drop out for various reasons, especially in a metastatic RR setting. So, let's say that 25 becomes 20. That's the potential. who knows? maybe they save ORR for ASCO. maybe the scan timeline is different for some reason. Maybe they have a cutoff for data that keeps the patient count for the presentation lower (that is typical for conference presentations). but anyway, the potential seems to be there for ORR data on a good number of patients.
The rollover portion, meanwhile, seems to have not been approved yet, so that will have to wait. At least officially there isn't an indication its been approved by the clinical site IRBs. DSMB cleared the proposal in december. I assume fda submission was more or less immediately after that. fda clearance in 30 days if no revisions were needed. Then it goes to clinical site IRBs and could bottleneck a bit there due to busy people being tough to schedule into meetings on short notice. And then the "process" at each clinical site follows to have it contractually costed and staffed and supplied etc. The process should be quicker than for the parent trial review, but still some sort of process takes place.
Its been long enough imo for any oddball delays to have cleared and for the entire process to be complete by now. I would imagine that if the rollover isn't approved already then it certainly should be this month. full enrollment and rollover implementation in month of May seem like pretty good bets. trying to be conservative, as almost EVERYTHING in pharma takes longer than expected.
official ORR data for the rollover portion doesn't seem possible for AACR or ASCO. *** i would expect to hear soon about attending ESMO gastro conference happening first week of july. regular abstract deadline was april 7. and then the larger ESMO conference is late october. anything that anyone wants to know regarding the goofily-named CLOVER trial will be known by then. They submitted the name change right after april fools btw.
SOC drugs have side effects that can cause dosing delays and thus scan delays, and in most trials a few patients drop out for various reasons, especially in a metastatic RR setting. So, let's say that 25 becomes 20. That's the potential. who knows? maybe they save ORR for ASCO. maybe the scan timeline is different for some reason. Maybe they have a cutoff for data that keeps the patient count for the presentation lower (that is typical for conference presentations). but anyway, the potential seems to be there for ORR data on a good number of patients.
The rollover portion, meanwhile, seems to have not been approved yet, so that will have to wait. At least officially there isn't an indication its been approved by the clinical site IRBs. DSMB cleared the proposal in december. I assume fda submission was more or less immediately after that. fda clearance in 30 days if no revisions were needed. Then it goes to clinical site IRBs and could bottleneck a bit there due to busy people being tough to schedule into meetings on short notice. And then the "process" at each clinical site follows to have it contractually costed and staffed and supplied etc. The process should be quicker than for the parent trial review, but still some sort of process takes place.
Its been long enough imo for any oddball delays to have cleared and for the entire process to be complete by now. I would imagine that if the rollover isn't approved already then it certainly should be this month. full enrollment and rollover implementation in month of May seem like pretty good bets. trying to be conservative, as almost EVERYTHING in pharma takes longer than expected.
official ORR data for the rollover portion doesn't seem possible for AACR or ASCO. *** i would expect to hear soon about attending ESMO gastro conference happening first week of july. regular abstract deadline was april 7. and then the larger ESMO conference is late october. anything that anyone wants to know regarding the goofily-named CLOVER trial will be known by then. They submitted the name change right after april fools btw.
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