WO2025203012 - KRAS G12C INHIBITOR FOR USE FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

National phase entry is expected:
Publication Number WO/2025/203012
Publication Date 02.10.2025
International Application No. PCT/IB2025/090001
International Filing Date 27.03.2025
Title **
[English] KRAS G12C INHIBITOR FOR USE FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER
[French] INHIBITEUR DE KRAS G12C DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT DU CANCER DU POUMON NON À PETITES CELLULES
Applicants **
NOVARTIS AG
Inventors
BITTON, Rafael Caparica
CUI, Xiaoming
LOBETTI BODONI, Chiara
YOVINE, Alejandro Javier
Priority Data
63/570,531   27.03.2024   US
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting2512
EPO Filing, Examination, Granting15650
Japan Filing, Examination, Granting2607
South Korea Filing, Examination, Granting2925
USA Filing, Examination, Granting7140
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Total: 30,834
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Abstract[English] The present invention relates to a method of treating non-small cell lung cancer (NSCLC) which harbors a KRAS G12C mutation, wherein the method comprises the administration of a therapeutically effective amount of KRAS G12C inhibitor 1-{6-[(4M)-4-(5-Chloro-6-methyl-5 1H-indazol-4-yl)-5-methyl-3-(1-methyl-1H-indazol-5-yl)-1H-pyrazol-1-yl]-2- azaspiro[3.3]heptan-2-yl}prop-2-en-1-one (Compound A), or a pharmaceutically acceptable salt, solvate or hydrate thereof, a therapeutically effective amount of pembrolizumab, a therapeutically effective amount of pemetrexed and a therapeutically effective amount of platinum therapy; in particular the present invention relates to a method of treating NSCLC wherein the NSCLC expresses at least 1% PD-L1 according to the tumor proportion score (TPS), more particularly wherein the NSCLC expresses less than 50% PD-L1 according to the tumor proportion score (TPS), more particularly wherein the NSCLC expresses PD-L1 1- 49% according to the tumor proportion score (TPS), even more particularly wherein the NSCLC expresses <1% PD-L1 according to the tumor proportion score (TPS).[French] La présente invention concerne une méthode de traitement du cancer du poumon non à petites cellules (NSCLC) qui héberge une mutation KRAS G12C. La méthode consiste à administrer une quantité thérapeutiquement efficace d'inhibiteur de KRAS G12C 1-6-[(4M)-4-(5-chloro-6-méthyl-5 1H-indazol-4-yl)-5-méthyl-3-(1-méthyl-1 H-indazol-5-yl)-1 H-pyrazol-1-yl]-2-azaspiro [3,3] heptan-2-yl}prop-2-en-1-one (composé A), ou un sel, solvate ou hydrate pharmaceutiquement acceptable de celui-ci, une quantité thérapeutiquement efficace de pembrolizumab, une quantité thérapeutiquement efficace de pémétrexed et une quantité thérapeutiquement efficace de thérapie au platine. En particulier, la présente invention concerne une méthode de traitement du NSCLC, le NSCLC exprimant au moins 1 % de PD-L1 selon le score de proportion tumorale (TPS), plus particulièrement le NSCLC exprimant moins de 50 % de PD-L1 selon le score de proportion tumorale (TPS), plus particulièrement le NSCLC exprimant PD-L1 de 1 à 49 % selon le score de proportion tumorale (TPS), encore plus particulièrement le NSCLC exprimant moins de 1 % de PD-L1 selon le score de proportion tumorale (TPS).

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