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  "documentTitle": "Nuvalent | Investor Presentation Deck | 31 slides",
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  "presentationDate": "2022-10-01 00:00:00",
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  "notes": "The slide outlines the clinical trial structure, including patient eligibility criteria and study objectives for both phases.",
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      "text": "CBR, clinical benefit rate; Chemo/I-O, platinum-based chemotherapy ± immunotherapy; DOR, duration of response; MTD, maximum tolerated dose; NSCLC, non-small cell lung cancer; ORR, overall response rate (RECIST 1.1); OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; RP2D, recommended phase 2 dose; ROS1+, ROS1-positive; TKI, tyrosine kinase inhibitor; TTR, time to response. a Patients with baseline concurrent oncogenic drivers identified on subsequent testing and patients without measurable disease are excluded from efficacy evaluation per prespecified protocol analysis plan.",
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      "text": "PATIENT POPULATION: Advanced solid tumors harboring ROS1 fusions; ≥ 1 prior ROS1 TKI for NSCLC; No limit to prior chemo/I-O; Excluded: concurrent oncogenic drivers; Evaluable but non-measurable disease allowed.",
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      "text": "OBJECTIVES: Primary: ORR by blinded, independent central review. Secondary: Additional efficacy measures (DOR, TTR, CBR, PFS, OS), intracranial activity, overall safety and tolerability, confirmation of PK profile.",
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      "text": "OBJECTIVES: Selection of RP2D and MTD; Overall safety and tolerability; PK characterization; Preliminary antitumor activity; Intracranial activity.",
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      "text": "PHASE 1 DOSE-ESCALATION",
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      "text": "OPEN-LABEL PHASE 2 COHORTS (PLANNED): Cohorts 2a-2e with Tumor Type, Prior ROS1 TKI, and Prior Chemo/I-O status.",
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      "text": "Study Design | ARROS-1: A Global Phase 1/2 Study of NVL-520 in Patients with Advanced ROS1-Positive NSCLC and Other Solid Tumors (NCT05118789)",
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