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H2R

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Alias Born 07/17/2014

H2R

Re: H2R post# 42292

Friday, 08/19/2022 3:27:25 PM

Friday, August 19, 2022 3:27:25 PM

Post# of 43835
Pre-specified in the original study protocol and in the SAP.

Analysis of the lower-risk-for-recurrence arm was pre-specified in the original study protocol and in the statistical analysis plan. This arm comprised about 40% of all study participants.

14.1% absolute OS advantage at 5-years in the lower-risk-for-recurrence arm (62.7% vs 48.6%) for Multikine+CIZ patients versus SOC patients. OS benefit was also shown at 1, 2, 3, and 4 years.

Nearly 4-year increase in median overall survival in the lower-risk-for-recurrence arm (101.7 months for Multikine+CIZ versus 55.2 months for the SOC).

Histopathological analysis confirmed the effect of Multikine, as 61 markers, ratios, and combinations showed a statistically significant effect in the lower-risk-for-recurrence arm (two-sided p<0.05) favoring Multikine+CIZ versus the SOC for OS, progression free survival, and loco-regional control outcomes.

Additional (confirmatory) progression-free survival benefit in the lower-risk-for-recurrence arm was observed for Multikine+CIZ versus the SOC.

No excess safety issues : The overall incidence of adverse events and serious adverse events in the Multikine arms was not substantially different versus the SOC.



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