PFS With Sotorasib Superior to Standard of Care in KRAS G12C-Mutant NSCLC


In the CodeBreaK 200 clinical trial, progression-free survival was extended with sotorasib treatment in patients with KRAS G12C-mutated non–small cell lung cancer vs standard of care chemotherapy.

Alexander I. Spira, MD, PhD, FACP

Alexander I. Spira, MD, PhD, FACP

Sotorasib (Lumakras) demonstrated a statically significant progression-frees survival (PFS) improvement and superiority over standard of care chemotherapy in patients with KRAS G12C-mutated non–small cell lung cancer (NSCLC) who received prior platinum-based doublet chemotherapy and immune checkpoint inhibition.1

“This confirms what we were expecting. The efficacy of this targeted therapy for KRAS G12C-mutated NSCLC in the second-line is better than the current chemotherapy,” Alexander I. Spira, MD, PhD, FACP, medical oncologist, and the co-cirector, and director, Thoracic and Phase I Program at Virginia Cancer Specialist Research Institute, and a clinical assistant professor at John Hopkins University told Targeted Oncology™.

With a PFS improvement, the phase 3 multicenter, randomized, open-label, active-controlled CodeBreaK 200 clinical trial met the primary end point (NCT04303780).

The efficacy and safety of sotorasib in 345 patients locally advanced and unresectable or metastatic NSCLC harboring KRAS G12C mutations is being evaluated in the study. The secondary efficacy end points of the study include overall survival, objective response rate, patient-reported outcomes, quality-of-life assessment, duration of response, time to response, and disease control rate. The secondary safety end points include the number of patients with clinically significant change in vital signs, treatment-emergent adverse events (AEs), laboratory tests, and treatment-relates AEs. The study is also assessing pharmacokinetics.2

The study includes male and female patients aged 18 years or older with an ECOG performance status of ≤ 1, and pathologically documented disease that has been previously treated. Patients excluded from the study are those with active brain metastases, myocardial infarction within 6 months of day 1 in the study, and gastrointestinal tract disease that interferes with a patient’s ability to take oral medication.

CodeBreaK 200 is active at 274 locations across the United States, Canada, South America, Europe, Asia, and the Oceania.

"Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting," said David M. Reese, MD, executive vice president of Research and Development at Amgen, in a press release. "We are grateful to all of the investigators and patients who participated in this first randomized, controlled clinical trial of a KRAS G12C inhibitor."


1. AMGEN announces topline data from Lumakras® (sotorasib) phase 3 trial in non-small cell lung cancer. News release. Amgen. August 31, 2022. Accessed August 31, 2022.

2. Study to compare AMG 510 "proposed INN sotorasib" with docetaxel in non–small cell lung cancer (NSCLC) (CodeBreak 200). Updated August 3, 2022. Accessed August 31, 2022.

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