Investor Presentaiton
Oncology
Hematology
Cell Therapy
Immunology
Cardiovascular
repotrectinib (ROS1/NTRK)
Indication
ROS1 NSCLC & NTRK+ Solid Tumors
Phase/Study
Phase I/II - TRIDENT-1
N = 500
# of Patients
Design
Phase I:
Dose escalation; food-effect, dose escalation with food; & Midazolam DDI
Phase II: Expansion cohorts
• ROS1 TKI-naïve ROS1+ NSCLC 160 mg QD for the first 14 days, then 160 mg BIDa
• 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC
Endpoints
Status
CT Identifier
•
2 Prior ROS1 TKIS ROS1+ NSCLC (No Chemo or I-O)
•
1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or I-O)
⚫ TRK TKI-naïve NTRK+ solid tumors
TRK TKI-pretreated NTRK+ solid tumors
Primary:
⚫ Phase I: DLTS, RP2D
Phase II: ORR
Key Secondary
⚫ Phase II: DOR, IC-ORR
Recruiting
U.S. FDA Priority Review in ROS1+ NSCLC: PDUFA November 27, 2023
ROS1 data presented at IASLC WCLC 2023
NCT03093116
ll Bristol Myers Squibb Q3 2023 Results
aBased on tolerability
Not for Product Promotional Use
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