Biomarker Subgroup Analyses Pretreated KRAS G12C-Mutated NSCLC Patients Benefit from Sotorasib

Ferdinandos Skoulidis, MD, from MD Anderson speaks about the ASCO 2023 abstract on Biomarker Subgroup Analyses Pretreated KRAS G12C-Mutated NSCLC Patients Benefit from Sotorasib.


Ferdinandos Skoulidis, MD, PhD, from the MD Anderson Cancer Center, presented the results of biomarker subgroup analyses from the phase 3 CodeBreaK 200 trial. 

The study evaluated the efficacy of sotorasib compared to docetaxel in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation, a common genetic alteration in lung cancer.

The CodeBreaK 200 trial enrolled patients with previously treated KRAS G12C-mutated NSCLC, which represents a subset of patients with limited treatment options. 

The study aimed to assess the efficacy and safety of sotorasib, a targeted therapy designed to inhibit the abnormal signaling caused by the KRAS G12C mutation.

The biomarker subgroup analyses focused on various patient characteristics and treatment outcomes. One key finding was that sotorasib demonstrated consistent efficacy across various subgroups, including age, sex, smoking status, and ethnicity. 

This suggests that the drug could potentially benefit a broad range of patients with KRAS G12C-mutated NSCLC.

Moreover, the analyses revealed that patients who received prior immune checkpoint inhibitors (ICIs) had similar responses to sotorasib compared to those who did not receive ICIs. 

This is particularly significant as ICIs have become a standard treatment option in advanced NSCLC, and the ability of sotorasib to provide clinical benefit regardless of prior ICI therapy is promising.

Another noteworthy observation was that patients with liver metastases, a challenging subgroup to treat, derived clinical benefit from sotorasib. 

This finding indicates that sotorasib may be a valuable therapeutic option for patients with advanced NSCLC and liver involvement.

Safety analyses showed that sotorasib had a manageable side effect profile, with most adverse events being of low grade. The most common side effects observed were diarrhea, nausea, and fatigue. 

These findings highlight the tolerability of sotorasib and support its potential as a well-tolerated treatment option for patients with pretreated KRAS G12C-mutated advanced NSCLC.

In conclusion, the biomarker subgroup analyses of the CodeBreaK 200 trial presented by Dr. Skoulidis provide valuable insights into the efficacy and safety of sotorasib in patients with pretreated KRAS G12C-mutated advanced NSCLC. 

The consistent efficacy observed across various patient subgroups, including those with prior ICI therapy and liver metastases, suggests that sotorasib has the potential to benefit a wide range of patients with this genetic alteration. 

These findings contribute to the growing body of evidence supporting sotorasib as a promising targeted therapy for KRAS G12C-mutated NSCLC, offering hope for improved outcomes in this patient population.

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