Nuvalent
study design a global phase study of in patients with advanced positive and other solid tumors | Nuvalent
Company
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Industry
Deck date
May 2023
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15 of 39
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Investor Presentation
April 2024
a global first in human phase clinical trial of in advanced positive and other solid tumors dose preliminary data presented all treated population enrollment completed august updated data to be presented at medical meeting patient population harboring fusions by local testing prior for no limit to number prior chemotherapies or excluded concurrent drivers alk met ret or evaluable but non measurable disease allowed objectives enrollment initiated data as for patients treated by dose cohorts all doses dose expansion for dose optimization all treated population response evaluable population selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity central nervous system dose toxicities milligram maximum tolerated dose non small cell lung cancer once daily recommended with concurrent evaluation per protocol an patients drivers identified on plan tyrosine kinase testing patients without measurable disease are excluded from efficacy first response evaluation is pending patients response evaluable population prospect defined as all patients with measurable disease without concurrent driver who post response assessment treatment due progression death prior to the first response additional patients for no measurable tumor with alternate driver met amplification discontinued study treatment prior to first response assessment tumor pancreatic cancer source | Nuvalent
Investor Presentation
April 2024
a global first in human phase clinical trial of in advanced alk positive and other solid tumors dose preliminary data presented all treated population enrollment completed updated data to be presented at medical meeting enrollment initiated june data cut off dose cohorts all doses patient population dose harboring alk fusion or activating mutation by local testing patients with prior or alk for dose optimization prior chemotherapies all treated population excluded concurrent drivers met ret or evaluable but non measurable disease allowed response evaluable population objectives selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity non small cell with cor evaluation per i platinum base dor duration response maximum cancer objective rate overall survival on free survival dose tyrosine kinase drivers identified on subsequent testing patients without measurable disease are excluded from efficacy time to response inhibitor without prior to the first response for response no measurable disease at tumor with driver met amplification no post scan discontinued treatment for reasons than tumor pancreatic atypical carcinoid lung source lin | Nuvalent
Investor Presentation
February 2024
a global first in human phase clinical trial of in advanced positive and other solid tumors dose preliminary data presented all treated population enrollment completed august updated data to be presented at medical meeting patient population harboring fusions by local testing prior for no limit to number prior chemotherapies or excluded concurrent drivers alk met ret or evaluable but non measurable disease allowed objectives selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity enrollment initiated data as for patients treated by dose cohorts all doses dose expansion for dose optimization all treated population response evaluable population need i central nervous system dose limit once daily recommended patients with concurrent evaluation per toxicities milligram maximum tolerated tyrosine kinase identified on subsequent testing patients without measurable disease are excluded from efficacy ose non small cell lung cancer first response evaluation is pending response evaluable population prospectively defined as all patients with measurable disease without concurrent treatment due to progression death prior to the first tumor with altern driver met discontinued study treatment prior to first assessment tumor pancreatic cancer | Nuvalent
Investor Presentation
February 2024
a global first in human phase clinical trial of in advanced alk positive and other solid tumors dose preliminary data presented all treated population enrollment completed updated data to be presented at medical meeting enrollment initiated june data cut off dose cohorts all doses patient population dose harboring alk fusion or activating mutation by local testing patients with prior or alk for dose optimization prior chemotherapies all treated population excluded concurrent drivers met ret or evaluable but non measurable disease allowed response evaluable population objectives selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity on alk clinic non generation alk i rate i platinum base dor duration response maximum cancer objective survival progression free survival with cor evaluation per first response me to response evaluable population prospectively defined as all patients with at tumor scan discontinued treatment for reasons than tumor tic atypical carcinoid lung source lin | Nuvalent
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