Half-Year 2022 Financial and Clinical Trials Update
Rozlytrek (entrectinib)
CNS-active and selective inhibitor of NTRK/ROS1
Indication
Locally advanced or metastatic tumors with
ROS1 gene rearrangement
Locally advanced or metastatic tumors with
NTRK1/2/3 gene rearrangement
Pediatric tumors with NTRK 1/2/3, ROS-1
or ALK rearrangement
Roche
Phase/study
# of patients
Phase II
STARTRK2
N-300 total
Single arm with Baskets based on tumor type and
genomic alteration status
Phase II
STARTRK2
N-300 total
Single arm with Baskets based on tumor type and
genomic alteration status
Phase I/lb
STARTRK - NG
N-80
Single arm with Baskets based on tumor type and
genomic alteration status
Design
▪ Objective response rate
Primary endpoint
FPI Q1 2016
Status
Data presented at WCLC 2018
■ Objective response rate
FPI Q1 2016
Data presented at ESMO 2018
■ Maximum tolerated dose and RPTD
FPI Q2 2016
Initial data presented at ASCO 2019
■ Breakthrough Therapy Designation granted by FDA (Q2 2017), PRIME designation granted by EMA (Q1 2018) and Sakigake Designation granted by MHLW
(Q4 2017) for NTRK fusion-positive, locally advanced or metastatic solid tumors
Filed in US Q4 2018 and EU Q1 2019
■ Approved in US Q3 2019 and EU Q3 2020
Published in Lancet Oncol. 2020 Feb;21(2):261-271 and 271-282
CT Identifier
NCT02568267
NCT02568267
NCT02650401
ALK-Anaplastic lymphoma kinase; CNS-Central Nervous System; MHLW=Ministry of Health, Labor and Welfare; NTRK-neurotrophic receptor tyrosine kinase; PRIME= priority medicines; RPTD=Recommended phase II dose;
ROS1-C-ros oncogene 1; WCLC=World Conference on Lung Cancer; ESMO-European Society for Medical Oncology; ASCO-American Society of Clinical Oncology
100
OncologyView entire presentation