Saturday, October 24, 2020 1:56:56 PM
Senti, I have a question pertaining to your excellent analysis. It involves the estimate that for the early Treatment arm, the current DCVax-L trial protocol assumed a mOS of at least 28.3 months from surgery.
That presents difficulties if we still assume that the blended trial mOS of 23.1 months which was likely obtained from the first 165-166 patients, is still valid.
If the mOS of the Treatment arm were indeed 5.2 months longer than the mOS of the entire trial (28.3-23.1=5.2) then the mOS of the SOC arm would only be equal to about 10.9 months after surgery (28.3-23.1=5.2
months; 5.2 months X 2.34=12.2 months; 23.1 months-12.2 months = 10.9 months;).
EXPLANATION: I multiplied 5.2 months (the difference between the assumed 28.3 months minimal mOS of the Treatment and the 23.1 months blended mOS) by 2.34 (the numerical ratio of 2.34 Treatment patients to 1.0 SOC patient) and obtained 12.6 months which were subtracted from the 23.1 months overall mOS, to yield the hypothetical mOS of 10.9 months of the SOC arm.
However, an mOS of 10.9 months for the SOC arm is IMHO very unrealistic. I am therefore assuming that the final mOS for the entire (blended) trial is higher than the original 23.1 months and is most likely much closer to let's say 25 months. That would be consistent with about a 17 months mOS for the SOC arm, a more realistic outcome IMHO.
That presents difficulties if we still assume that the blended trial mOS of 23.1 months which was likely obtained from the first 165-166 patients, is still valid.
If the mOS of the Treatment arm were indeed 5.2 months longer than the mOS of the entire trial (28.3-23.1=5.2) then the mOS of the SOC arm would only be equal to about 10.9 months after surgery (28.3-23.1=5.2
months; 5.2 months X 2.34=12.2 months; 23.1 months-12.2 months = 10.9 months;).
EXPLANATION: I multiplied 5.2 months (the difference between the assumed 28.3 months minimal mOS of the Treatment and the 23.1 months blended mOS) by 2.34 (the numerical ratio of 2.34 Treatment patients to 1.0 SOC patient) and obtained 12.6 months which were subtracted from the 23.1 months overall mOS, to yield the hypothetical mOS of 10.9 months of the SOC arm.
However, an mOS of 10.9 months for the SOC arm is IMHO very unrealistic. I am therefore assuming that the final mOS for the entire (blended) trial is higher than the original 23.1 months and is most likely much closer to let's say 25 months. That would be consistent with about a 17 months mOS for the SOC arm, a more realistic outcome IMHO.
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