Overall Survival Analysis of the Phase III CodeBreaK 300 Study of Sotorasib Plus Panitumumab Versus Investigator's Choice in Chemorefractory KRAS G12C Colorectal Cancer
Pietrantonio, Filippo (Fondazione Irccs Istituto Nazionale dei Tumori)
Salvatore, Lisa (Fondazione Policlinico Universitario Agostino Gemelli Irccs)
Esaki, Taito (National Hospital Organization Kyushu Cancer Center)
Modest, Dominik Paul (Charité-Universitätsmedizin Berlin)
Taieb, Julien (Université Paris Cité)
Karamouzis, Michalis V. (National and Kapodistrian University of Athens-School of Medicine)
Ruiz-Garcia, Erika (INCAN-Instituto Nacional de Cancerologia)
Kim, Tae Won (University of Ulsan)
Kuboki, Yasutoshi (National Cancer Center Hospital East)
Cunninghamo, D. (The Royal Marsden Hospital)
Yeh, Kun Huei (National Taiwan University College of Medicine)
Chan, Emily (Amgen Inc.)
Chao, Joseph (Amgen Inc.)
Tran, Qui (Amgen Inc.)
Cremolini, Chiara (Università di Pisa)
Fakih, Marwan (City of Hope Comprehensive Cancer Center)
Paez, David (Institut de Recerca Sant Pau)
Meriggi, Fausto (Fondazione Poliambulanza-Istituto Ospedaliero)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2025
Resum:	In the phase III CodeBreaK 300 study, sotorasib 960 mg-panitumumab significantly prolonged progression-free survival (PFS) versus investigator's choice (trifluridine/tipiracil or regorafenib) in patients with KRAS G12C-mutated chemorefractory metastatic colorectal cancer (mCRC). One hundred sixty patients were randomly assigned 1:1:1 to receive sotorasib 960 mg-panitumumab (n = 53), sotorasib 240 mg-panitumumab (n = 53), or investigator's choice (n = 54; crossover permitted after primary analysis). Overall survival (OS) analysis, a key secondary end point, although not adequately powered, was prespecified at 50% maturity (after approximately 80 deaths). In this study, we report the OS, updated overall response rates (ORRs), and data for safety. After a median follow-up of 13. 6 months, 24, 28, and 30 deaths occurred in the sotorasib 960 mg-panitumumab, sotorasib 240 mg-panitumumab, and investigator's choice arms, respectively; updated objective response rates (ORRs; 95% CI) were 30. 2% (95% CI, 18. 3 to 44. 3), 7. 5% (95% CI, 2. 1 to 18. 2), and 1. 9% (95% CI, 0. 0 to 9. 9), respectively. Compared with investigator's choice, the hazard ratios (HRs [95% CI]) for OS were 0. 70 (95% CI, 0. 41 to 1. 18; two-sided P =. 20) with sotorasib 960 mg-panitumumab and 0. 83 (95% CI, 0. 49 to 1. 39; two-sided P =. 50) with sotorasib 240 mg-panitumumab. No new safety signals were observed. Although not statistically significant, the observed OS HR and ORR along with prior PFS and safety findings support sotorasib 960 mg-panitumumab as a standard of care in patients with chemorefractory KRAS G12C mCRC.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; Colorectal Neoplasms ; Female ; Humans ; Male ; Middle Aged ; Mutation ; Panitumumab ; Phenylurea Compounds ; Piperazines ; Progression-Free Survival ; Proto-Oncogene Proteins p21(ras) ; Pyridines ; Pyrimidines ; Sulfonamides ; Thymine
Publicat a:	Journal of clinical oncology, Vol. 43, Num. 19 (January 2025) , p. 2147-2154, ISSN 1527-7755

DOI: 10.1200/JCO-24-02026
PMID: 40215429

15 p, 1.0 MB

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