Nuvalent
clinical development strategy for 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 type treatment status prior prior i a positive naive none none positive treated any positive solid tumor any prior therapy registrational intent exploratory cohort an any line line benefit rate dor duration of response objective response rate overall survival progression free survival pro patient reported outcomes once daily tyrosine kinase inhibitor time to response approximate cohort size subject to change either or platinum based chemotherapy with or without with initial of either or includes who do not qualify any of the other cohorts | Nuvalent
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Industry
Deck date
January 2024
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38 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 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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