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Link to article on N of 1 trials, not only for already approved drugs, but future trials of new drugs. When done in cloud based setting, this has potential to greatly reduce cost vs RCT trials, plus it can help individual patient determine if a drug works for her. (These are individually blinded trials, but outcome is provided after the trial to each individual. How many of us with chronic diseases have argued with doctor that a medicine does more harm than good for us as individuals, even though it helps a percentage of the population as a whole.) They can statistically collect all the individuals results to determine overall population efficacy.
I think this might be a solution for emab lupus trials (although it still requires the cost of mfg the drugs). When I read this article, I was haunted by the pleas of the woman in our lupus trials who was noticeably helped by emab (she was able to go back to work) but had to go back to a life of misery after the trials ended.
The article says this may be a better way to test orphan drugs where it is hard to enroll enough patients.
Hmmm, administrative error is pretty thin. The other Daiichi compound, U3-1402, has an abstract, as do most of the other oral presentations. Although there are a few others I found missing abstracts. I don't know enough about these things to come up with a viable theory.
But, it seems to me that the market has assumed the worst, that the 1062 data didn't fall apart. I think it's unlikely that the results could continue their incredible trend. They had 100% response from the 8mg cohort, albeit only 4 patients. Still 4/4 is jaw dropping, especially measured against the increasing effectiveness as they escalated the dose, and they aren't done escalating yet.
But, for perspective, consider the response from the immunotherapy Keytruda. They had nsclc results a year or two ago that stunned - 42% response in treatment naive patients, and 23% in previously treated. Is it really plausible that Daiichi could have a compound that is yielding near 100% response in previously treated patients? I don't think so. There must be a caveat, maybe a safety signal, maybe a quirk in the way these scans are being read. Either way, it's BS that they didn't release the the abstract.
>Still 4/4 is jaw dropping, especially measured against the increasing effectiveness as they escalated the dose, and they aren't done escalating yet.<
According to page 22 of the Daiichi's presentation you provided the other day (thank you!), the Dose Expansion Cohort started already in July, 2019. Could it be the dose escalating is complete and has been analyzed as a dose level based on MDT would be needed for the expansion cohort, yes?
If so, I could see this being either a negative or a positive...toxity/AE's were significant enough to determine a MTD and to select a lower dose level than say for example 8mg, or alternatively, results are so stellar/jaw dropping at the 8mg level, why continue dose escalation. Don't know, just trying to reconcile DS's presentation with the no abstract.
Other possibility is nothing new to report when the late Abstracts were due...no clue...
competitor adc The presentation was accepted as a minioral presentation. However,its her3 adc was accepted as oral presentation.If the data was really impressive as the original asco data, should it be accepted as full oral presentaion. Just my speculation.