Cáncer de pulmón actualización en terapias dirigidas ROS1/NTRAK

23 / 32

Integrated efficacy and safety analysis of entrectinib:
NTRK fusion-positive solid tumours
1.
2. Drilon, et al. Cancer Discov 2017
Data cut-off 31 May 2018
§Patients with at least 6 months of follow up
*Per blinded independent central review measured by RECIST v1.1
†Patients with measurable and non-measurable CNS lesions at baseline OS: overall survival; PFS: progression-free survival
Integrated analysis
Efficacy population§
54 adult patients with NTRK
fusion-positive, TRK
inhibitor-naïve solid tumours
Safety population
355 patients overall have
received entrectinib
(all tumour types and gene
rearrangements)
Primary endpoints*
ORR and DoR
Secondary
endpoints*
PFS and OS
Intracranial ORR
and DoR†
Safety and tolerability
STARTRK-12
Phase I dose escalation
n=2 NTRK + patients
ALKA-372-0012
Phase I dose escalation
n=1 NTRK + patient
STARTRK-21
Phase II, multicentre, global basket study 600mg QD, 28-day
cycle
n=51 NTRK + patients