Nuvalent
planned clinical development for alk pronged strategy supports goal of moving up the treatment paradigm previously treated naive and treated global open label cohort phase with registrational intent strategy naive head to head phase study with registrational intent phase opportunity accelerated approval in cohort tumor type prior prior i detail a prior or lines prior or or lines registrational intent ale prior with in of therapy male line or eons any solid tumor prior or systemic therapy or whom no satisfactory standard therapy exists an exploratory cohort phase objectives primary by blinded independent central review secondary additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile line line line benefit rate dor duration of response objective response rate overall survival progression free survival tyrosine kinase inhibitor time to response | Nuvalent
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Deck date
January 2024
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26 of 42
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clinical development strategy for cion ongoing phase supports goal of moving up the treatment paradigm naive and treated ongoing global open label cohort phase with registrational intent enrollment planned across north and all patients receive at primary objective by blinded independent central review secondary objectives additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile pros phase opportunity approval in both and cohort tumor status i bepale treatment prior prior a positive naive none a positive any positive solid tumor any prior therapy a a none a registrational intent exploratory cohort progression free | Nuvalent
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planned clinical development for alk pronged strategy supports goal of moving up the treatment paradigm previously treated naive and treated enrollment across north and all patients receive at phase ongoing global open label cohort study with registrational intent treated patients with phase patient population prior prior any generation or prior or prions none naive any not eligible other cohorts other solid tumors prior or systemic therapy or whom no satisfactory standard therapy exists prior i lines lines any opportunity early exploratory data generation in ongoing phase head to head phase study with registrational intent phase objectives primary by blinded independent central review secondary additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile benefit rate dor duration of response objective response rate overall survival progression free survival tyrosine kinase inhibitor time to response excludes patients who received as the prior | Nuvalent
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planned clinical development for alk pronged strategy supports goal of moving up the treatment paradigm previously treated naive and treated enrollment across north and all patients receive at opportunity early exploratory data generation in ongoing phase head to head phase study with registrational intent phase ongoing global open label cohort study with registrational intent treated patients with phase patient population prior prior any generation or prior or ace prior none naive any not eligible other cohorts other solid tumors prior or systemic therapy or whom no satisfactory standard therapy exists phase objectives primary by blinded independent central review prior i lines any me secondary additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile benefit rate dor duration of response objective response rate survival progression free survival tyrosine kinase inhibitor time to response excludes patients who received as the prior | Nuvalent
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