Innovative Therapeutics in Oncology and Neuroscience slide image

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 - Oncology
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