CR data is inflated because a significant portion of patients have progressed to transplant. A large proportion is explained by the fact that the study includes healthier patients who can tolerate transplant treatment, and they are treated in a highly specialized center. Additionally, the number of TP53 mutations is high; transplant treatment is desired for these patients. When proceeding to transplant, there is no waiting to see what happens, whether the response lasts or not; instead, it is carried out if the patient is eligible and a transplant is available.
That CR data would have absolutely required at least a swimmer plot alongside it, which would show the time to response, duration, and the start date of progression to transplant treatment.
Regarding the duration of responses. IWG2023 does not, in my opinion, explicitly state what duration of response is officially accepted. However, we know that short-duration responses do not correlate with OS. Especially in TP53. The FDA certainly knows this and can inquire about the duration of responses if necessary.
The now reported duration of responses in mTP53 patients (10.2 months) was at least omitted from the stock exchange release, because it was a KM estimate, based on 8 patients of whom 6 were censored, the confidence interval was 0.3 months - NR! So the data, although “true and correct” in itself, is just noise, because only 2 events (loss of response) have been documented! And note that patients who received a transplant can no longer lose response in that study; instead, they are censored and exit the at-risk population when transplant treatment begins.
In wt patients, the KM estimate for the duration of responses was 6.2 months; here, significantly fewer were censored, 2/9; this is a much more reliable figure. (1.9 months - NR)
I don’t know where Bono’s 12 months comes from; perhaps it’s an individual patient’s result, like a data highlight / case report. One can write about such things on LinkedIn if desired; it doesn’t seem to be information relevant enough to affect the company.