CodeBreaK 100: Patient-reported outcomes evaluating sotorasib in KRAS p.G12C mNSCLC

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Published: 6 Jul 2021
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Dr Alex Spira - Virginia Cancer Specialists Research Institute, Fairfax, USA

"Dr Alex Spira speaks to ecancer about the patient-reported outcomes (PRO) from the phase 2 CodeBreaK 100 trial evaluating sotorasib in KRAS p.G12C mutated non-small cell lung cancer (NSCLC). Initially, he explains the background of the study.

Dr Spira then talks about the methodology and key results of the study. In patients from the single-arm phase 2 trial of sotorasib, PRO measures suggested maintenance or improvement of global health status/QoL, physical functioning, and the severity of key lung cancer-related symptoms, including cough, dyspnea, and chest pain. Self-reported side effect bother was minimal.

Dr Spira says that the data, together with the encouraging efficacy and safety profiles, strongly support the use of sotorasib in this population. He concludes by discussing how the results from this study can impact the future treatment of mNSCLC.

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content.

This is the CodeBreaK 100 study and it’s the update on the patient-reported outcomes. It’s a corollary to the approved drug which just came out around the same time that goes along with the efficacy. We reported on the efficacy in a separate presentation and this is, again, reporting on patient-reported outcomes and how well the patients did. So it demonstrated, in essence, that the quality of life and other metrics that we typically use for patient reported outcomes were very favourable, going along with the efficacy of the drug.

What was the methodology used in this study?

During this study what we used is we used patient-reported questionnaires and followed symptoms along with the patient outcomes that were reported separately.

What were your findings?

So the key finding is that, if anything, side effects of sotorasib were actually very good. There were not a lot of side effects, it was very well tolerated, meaning that not only do we have a drug that works in this patient population with an unmet need but it did not adversely affect quality of life. In fact, quality of life was actually improved with treatment with the drug which is what you would want with a targeted therapy.

How can these results impact the future treatment of NSCLC?

What these results basically showed was that sotorasib is an efficacious drug that is very well tolerated. So physicians and clinicians should have very little reluctance about using the drug in that it does improve quality of life and the side effects are very tolerable. So, again, we have an approved drug that is tolerable which is what you would want in a targeted therapy.

To remind everybody, until the approval of this drug KRAS treatments did not exist. So it was a huge unmet need so we now have an approved drug for these KRAS G12C mutants which represents between 10-15% of the lung cancer population.

Is there anything else important that you would like to mention?

One of the most important things regarding the study is that now we have a targeted therapy that’s very well tolerated to remind everybody to test. You can’t use a targeted therapy if you’re not testing for these mutations. So please, reminding everybody to test, either be it tissue or blood or whatever means you have.