84% reduction in risk of tumors spreading to or growing in the
CNS as the first site of progression (HR=0.16 [95% CI: 0.10, 0.28]); P<0.0001b
Safety Profile
Exploratory Subgroup Analysis of Patients With CNS as the First
Site of Progression (Including Those Who Had Concurrent Systemic
Progression) 16 | IRC
All exploratory analyses are descriptive in nature. Subgroups were
not powered to show differences between treatment arms. 15
aSystemic progression without prior CNS progression
(ALECENSA n=36; crizotinib n=33); death prior to CNS or systemic
progression (ALECENSA n=11; crizotinib n=9). 3
bCause-specific HR and 95% CI were estimated by Cox model
where patients with competing events (systemic progression and death
prior to CNS or systemic progression) were censored at the time of
these events. P-values were estimated from two-sided
stratified cause-specific log-rank tests. 17
cExcludes 1 patient in the ALECENSA arm with no CNS
metastases by IRC who had received prior radiotherapy. 16
ALECENSA Delivered Durable CNS Responses
- 59% of patients
experienced a CNS response that lasted for a year or more with
ALECENSA vs 36% of patients with crizotinib 1
All exploratory analyses are descriptive in nature. Subgroups were
not powered to show differences between treatment arms. 15
1L=first-line; CI=confidence interval; CNS=central
nervous system; CR=complete response; HR=hazard ratio;
IRC=Independent Review Committee; ORR=objective response rate;
PFS=progression-free survival.