2024 World Conference on Lung Cancer (WCLC) - Posters-P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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The document outlines a phase III clinical trial, Krascendo 1, which compares the efficacy and safety of divarasib, a potent and selective KRAS G12C inhibitor, against two existing treatments, adagrasib and sotorasib, for KRAS G12C-mutated advanced or metastatic non-small cell lung cancer (NSCLC). The trial is a randomized, multicenter study involving participants aged 18 and older with previously treated NSCLC who have not received prior KRAS G12C or pan-KRAS/RAS inhibitor treatment.<br /><br />Key details include the study's endpoints, focusing primarily on progression-free survival (PFS), with secondary endpoints such as overall survival and response rates among others. Patients in the trial will receive either divarasib or a control drug (adagrasib or sotorasib) determined by local availability. Treatment will continue until disease progression or other indicated endpoints.<br /><br />Divarasib is highlighted for its superior in vitro potency and selectivity compared to adagrasib and sotorasib. Earlier studies demonstrated its promising antitumor activity and acceptable safety profile, thus hypothesized to significantly improve patient outcomes compared to the current treatments. <br /><br />The study will use statistical methods like the stratified Cox regression model and Kaplan-Meier estimation for data analysis, particularly assessing progression-free survival through time-to-event analysis. Enrolled patients will undergo regular assessments, including tumor evaluations, pharmacokinetics, and patient-reported outcomes to monitor the efficacy and safety of treatments.<br /><br />The trial is sponsored by F. Hoffmann-La Roche Ltd and involves collaboration from several international research institutions. The research aims to address unmet treatment needs in KRAS G12C-mutated NSCLC and enhance existing therapeutic strategies.

Asset Subtitle

Shirish Gadgeel

Meta Tag

Speaker Shirish Gadgeel

Topic Metastatic NSCLC – Targeted Therapy

Keywords

KRAS G12C inhibitor

divarasib

clinical trial

non-small cell lung cancer

NSCLC

progression-free survival

adagrasib

sotorasib

F. Hoffmann-La Roche

Kaplan-Meier estimation