Sotorasib with panitumumab for patients with KRAS G12C variants

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

Doublet therapy with sotorasib 960 mg once daily plus panitumumab (6 mg/kg IV every 2 weeks) (n = 53).

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

Doublet therapy with sotorasib 240 mg once daily plus panitumumab (6 mg/kg IV every 2 weeks) (n = 53).

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

Investigator's choice standard-of-care therapy with trifluridine-tipiracil (35 mg/m2) or regorafenib (160 mg once daily) (control group).

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

The median PFS was 5.6 months (95% CI, 4.2–6.3) in the 960 mg-sotorasib/panitumumab group, 3.9 months (95% CI, 3.7–5.8) in the 240 mg-sotorasib/panitumumab group, and 2.2 months (95% CI, 1.9–3.9) in the standard-of-care group.[61][Level of evidence B1]

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

The HR for progression of disease or death was 0.49 (95% CI, 0.3–0.8; P = .006) for the 960 mg-sotorasib/panitumumab group and 0.58 (95% CI, 0.36–0.98; P = .03) for the 240 mg-sotorasib/panitumumab group.

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

The objective response rate was 26.4% (95% CI, 15.3%–40.3%) in the 960 mg-sotorasib/panitumumab group, 5.7% (95% CI, 1.2%–15.7%) in the 240 mg-sotorasib/panitumumab group, and 0% (95% CI, 0.0%–6.6%) in the standard-of-care group. OS data are still not mature. However, at data cutoff the HRs were 0.77 (95% CI, 0.4–1.45) for the 960 mg-sotorasib/panitumumab group and 0.91 (95% CI, 0.48–1.71) for the 240 mg-sotorasib/panitumumab group when compared with standard-of-care therapy.

The phase III, multicenter, open-label CodeBreaK 300 trial (NCT05198934) included patients with metastatic colorectal cancer and KRAS G12C variants who previously received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.[61] The trial randomly assigned 160 patients 1:1:1 to receive one of the following regimens:The primary end point was PFS assessed by blinded independent central review according to RECIST 1.1. Secondary end points included OS and objective response rate.

Grade 3 or higher side effects occurred in 35.8% of patients who received 960 mg sotorasib/panitumumab, 30.2% of patients who received 240 mg sotorasib/panitumumab, and 43.1% of patients who received the standard of care. The most common adverse effects with combined sotorasib and panitumumab therapy were skin-related toxicities and hypomagnesemia.