Clinical colorectal cancer · 2026
Matching-Adjusted Indirect Comparison of Sotorasib Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab in Chemorefractory Metastatic Colorectal Cancer.
СтатьяСравнительное исследованиеКлиническое исследование III фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Salvatore Lisa, Fakih Marwan, Kuboki Yasutoshi, Hong David S, Modest Dominik Paul, Taieb Julien, Price Timothy Jay, Cremolini Chiara, Majer Istvan Matyas, Rehn Marko, Chan Emily, Chen Ziyan, Tran Qui, Pietrantonio Filippo
Аннотация
BACKGROUND: Sotorasib 960 mg plus panitumumab (soto960+pani) was investigated in chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC) in the phase 3 CodeBreaK 300 and phase 1b CodeBreaK 101 studies. In CodeBreaK 300, soto960+pani significantly improved progression-free survival (PFS) versus investigator's choice therapy (trifluridine/tipiracil [T/T] or regorafenib). The phase 3 SUNLIGHT study evaluated T/T plus bevacizumab (T/T+bev) in patients with unselected refractory mCRC and found longer survival times with T/T+bev than T/T monotherapy. Matching-adjusted indirect treatment comparisons (MAIC) were performed to compare the efficacy and safety of soto960+pani with new standard-of-care T/T+bev treatment.
MATERIALS AND METHODS: Clinical outcomes and adverse events (AEs) from CodeBreaK 300 and 101 (for soto960+pani) were compared with those from SUNLIGHT (for T/T+bev). By reweighting individual patient-level data from the pooled CodeBreaK studies, differences in baseline characteristics were adjusted. Odds ratios (ORs) were estimated for objective response rates; hazard ratios (HRs) were used for PFS and overall survival (OS).
RESULTS: From a pool of 93 patients, the effective sample size of soto960+pani with matched characteristics was 29 patients. Soto960+pani increased the likelihood of treatment response, with an adjusted OR of 5.7 (95% CI, 2.6-12.8) versus T/T+bev. HR for PFS was 0.77 (95% CI, 0.47-1.25); HR for OS was 0.44 (95% CI, 0.22-0.87), suggesting a survival benefit favoring soto960+pani. Grade ≥ 3 AEs occurred in 58% and 72% of soto960+pani-treated and T/T+bev-treated patients, respectively.
CONCLUSION: In this MAIC analysis, soto960+pani demonstrated statistically significant improvement in response rates and OS in patients with chemorefractory KRAS G12C-mutated mCRC.
MATERIALS AND METHODS: Clinical outcomes and adverse events (AEs) from CodeBreaK 300 and 101 (for soto960+pani) were compared with those from SUNLIGHT (for T/T+bev). By reweighting individual patient-level data from the pooled CodeBreaK studies, differences in baseline characteristics were adjusted. Odds ratios (ORs) were estimated for objective response rates; hazard ratios (HRs) were used for PFS and overall survival (OS).
RESULTS: From a pool of 93 patients, the effective sample size of soto960+pani with matched characteristics was 29 patients. Soto960+pani increased the likelihood of treatment response, with an adjusted OR of 5.7 (95% CI, 2.6-12.8) versus T/T+bev. HR for PFS was 0.77 (95% CI, 0.47-1.25); HR for OS was 0.44 (95% CI, 0.22-0.87), suggesting a survival benefit favoring soto960+pani. Grade ≥ 3 AEs occurred in 58% and 72% of soto960+pani-treated and T/T+bev-treated patients, respectively.
CONCLUSION: In this MAIC analysis, soto960+pani demonstrated statistically significant improvement in response rates and OS in patients with chemorefractory KRAS G12C-mutated mCRC.