Overall Survival Analysis of the Phase III CodeBreaK 300 Study of Sotorasib Plus Panitumumab Versus Investigator's Choice in Chemorefractory G12C Colorectal Cancer.
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Journal Volume
43
Journal Issue
19
Start Page
2147
End Page
2154
ISSN
1527-7755
Date Issued
2025-07
Author(s)
Pietrantonio, Filippo
Salvatore, Lisa
Esaki, Taito
Modest, Dominik Paul
Lopez-Bravo, David Paez
Taieb, Julien
Karamouzis, Michalis V
Ruiz-Garcia, Erika
Kim, Tae Won
Kuboki, Yasutoshi
Meriggi, Fausto
Cunningham, David
Chan, Emily
Chao, Joseph
Tran, Qui
Cremolini, Chiara
Fakih, Marwan
Abstract
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 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 = .20) with sotorasib 960 mg-panitumumab and 0.83 (95% CI, 0.49 to 1.39; two-sided = .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 G12C mCRC.
SDGs
Type
journal article