Investigators assessed the incidence and impact of NOTCH1mut in OMB110911 trial
NOTCH1mut associated with +12q, absence of 13q- and unmutated IGHV
No association between NOTCH1mut and ORR or CR
NOTCH1mut associated with shorter PFS in O-Chl arm but not in Chl arm
Cases without NOTCH1mut had statistically significant benefit from addition of Ofatumumab
Cases with mutant allele burden of >20%, effect of NOTCH1mut on PFS in O-Chl arm even more pronounced.
In OMB110911 trial, NOTCH1mut associated with absence of 13q-, +12q, unmutated IGHV and shorter PFS in multivariable analysis.
NOTCH1mut found to be predictive marker for reduced benefit from addition of Ofatumumab in O-Chl treatment arm.