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ASCO 2024: CodeBreaK 101 Update on Sotorasib Plus Chemotherapy for Advanced NSCLC

By: Julia Cipriano, MS
Posted: Friday, June 14, 2024

According to Bob T. Li, MD, PhD, MPH, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, in patients with KRAS G12C–mutated advanced non–small cell lung cancer (NSCLC), the KRAS inhibitor sotorasib plus platinum-doublet chemotherapy seemed to confer “robust” and “durable” responses with a manageable safety profile. These updated findings from the international phase Ib CodeBreaK 101 trial, which were presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8512), support the ongoing phase III CodeBreaK 202 trial of this regimen in the treatment-naive, PD-L1–negative setting.

Patients received first-line (n = 37; 64%) or second- or subsequent-line (n = 21; 36%) sotorasib plus carboplatin and pemetrexed, followed by maintenance therapy with sotorasib plus pemetrexed until disease progression or unacceptable toxicity. Of those who were treated in the second- or subsequent-line setting, 86% previously underwent anti–PD-1/PD-L1 therapy.

A total of 93% and 52% of patients experienced an any-grade or grade 3 or 4 treatment-related adverse event, respectively. Treatment-related febrile neutropenia led to death in 2% of patients.  

In the first-line setting, the objective response rate was 65%, and the disease control rate was 100%. The median durations of response and progression-free survival were 9.1 and 10.8 months, respectively. In the subgroup of patients with a tumor PD-L1 expression level of less than 1% (n = 19), the median progression-free survival was 11.9 months. The objective response and disease control rates were 42% and 84%, respectively, in the second- or subsequent-line setting. The median duration of response was not evaluable, and the median progression-free survival was 8.3 months. The overall survival data remain immature.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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