Sotorasib shows superior PFS and ORR compared to docetaxel for NSCLC

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Published: 12 Sep 2022
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Dr Silvia Novello - University of Turin, Turin, Italy

Dr Silvia Novella speaks to ecancer about the CodeBreaK 200 study, which is the first randomised phase 3 trial, evaluating sotorasib, a selective KRAS G12C inhibitor, in pretreated patients with NSCLC (after prior platinum-based chemotherapy and a immune checkpoint inhibitor). 

The primary endpoint for the study was progression-free survival assessed by blinded independent central review per RECIST 1.1. Secondary endpoints included objective response rate, disease control rate, overall survival and safety. 

The results demonstrated that oral sotorasib showed a superior progression-free survival and an objective response rate compared to standard of care intravenous docetaxel, and had a more favourable safety profile.

This randomised phase III trial is something that we expected as researchers and physicians. Why I’m
saying this, because today we are treating more or less one third of our advanced non-small cell lung
cancer patients with precision medicine and we are looking to enlarge this population. Here we are
talking about the KRASG12C mutated patients that are a large percentage of our advanced non-small
cell lung cancer patients.

We were looking at a confirmation from the phase II data. We know from the history of the research
that not always there is a confirmation moving from phase II to phase III data. In this case I can say
without any doubt that what we have seen, mainly in terms of PFS and also from the early data
presented in terms of OS, there is in the phase III a confirmation that sotorasib in the G12C KRAS
mutated patients is better than the standard of care, and the standard of care is mono-chemotherapy,
so docetaxel, becoming a new drug in the context of precision medicine for these patients with an
oncogene addiction.