Innovative Therapeutics in Oncology and Neuroscience
Repotrectinib
Potential to Be Best-in-Class ROS1/TRK Inhibitor in TKI-Naïve and Treatment-
Resistant Settings
Approved
(U.S.)
Indications:
Strategic Collaboration with Turning Point Therapeutics¹ on Repotrectinib
Ongoing global
registrational Phase 1/2
TRIDENT-1 study
ROS1+ advanced NSCLC in TKI-naïve and
-pretreated patients; NTRK+ solid tumors in
TKI-naïve and -pretreated patients
An important late-stage asset
to strengthen our lung
cancer franchise
Positive Topline Results from Global TRIDENT-1 Study and China Subpopulation
Global Topline Efficacy Analyses
ROS1+ TKI-naïve NSCLC (n=71): CORR 78.9%²; m PFS 35.7 mos³
ROS1+ TKI-pretreated NSCLC with 1 prior TKI and 1 prior
chemotherapy (n=26): CORR 42.3%2
ROS1+ TKI-pretreated NSCLC with 2 prior TKIs without prior
chemotherapy (n=18): CORR 27.8%2
ROS1+ TKI-pretreated NSCLC with 1 prior TKI without prior
chemotherapy (n=56): CORR 37.5%²; mPFS 9.0 mos³
– NTRK+ TKI-naïve advanced solid tumors (n=35): CORR 54%4
NTRK+ TKI-pretreated advanced solid tumors (n=44): CORR 43.2%4
Next Step
Potential NDA approval for ROS1 NSCLC by NMPA in 2024
China Subpopulation Topline Efficacy Analyses 5
ROS1+ TKI-naïve NSCLC: CORR 91% (n=11)
ROS1+ TKI-pretreated NSCLC with 1 prior TKI and prior
chemotherapy: CORR 67% (n=3)
ROS1+ TKI-pretreated NSCLC with 2 prior TKIs without prior
chemotherapy: CORR 50% (n=4)
ROS1+ TKI-pretreated NSCLC with 1 prior TKI without prior
chemotherapy: CORR 36% (n=11)
Core Opportunity
14K-21K annual incidence of ROS1 rearrangement of NSCLC
(2~3%); NTRK of ~0.5% with other advanced solid tumors 6 in China
30
Abbreviations: Blinded Independent Central Review (BICR), confirmed objective response rate (CORR).
Notes: (1) A wholly owned subsidiary of Bristol Myers Squibb Company. (2) ENA 2022 presentation number 2LBA, ORR per RECIST 1.1 and assessed by BICR; primary efficacy population includes patients pooled from Phase 1 and 2 that began
repotrectinib treatment at least 8 months prior to data cutoff date of June 20, 2022; (3) An oral presentation (Abstract #OA03.06) at the IASLC 2023; (4) ENA 2022 poster #209, ORR per investigator; efficacy data cutoff date for NTRK+ cohorts is
August 24, 2022; (5) Data from the Phase 2 portion of TRIDENT-1 with a data cutoff of 11-Feb-2022 with responses confirmed per RECIST 1.1 and assessed by BICR; (6) Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell
lung cancer, Thoracic Cancer January 2019; Farago AF, Le LP, Zheng Z, Muzikansky A, Drilon A, Patel M, et al. Durable Clinical Response to Entrectinib in NTRK1-Rearranged Non-Small Cell Lung Cancer. J Thorac Oncol. 2015;10(12):1670-4..
Clinical Data -
OncologyView entire presentation