Precision Medicine Group’s Post

Name: Precision Medicine Group on LinkedIn: The accelerated approval of sotorasib for KRAS-mutated lung cancer sparked…
Uploaded: 2024-12-10T15:00:06.705Z
Duration: 1 min 32 s
Channel: Precision Medicine Group
Description: The accelerated approval of sotorasib for KRAS-mutated lung cancer sparked critical discussions about dosing, trial design, and patient-centered care. Precision Chief Medical Officer, Harpreet Singh, MD, joins Matthew Hadfield, DO, to share lessons learned and explore how these insights are shaping the future of oncology trials. Watch the full interview to learn more: https://lnkd.in/e9CxCy7Q

Precision Medicine Group

188,610 followers

The accelerated approval of sotorasib for KRAS-mutated lung cancer sparked critical discussions about dosing, trial design, and patient-centered care. Precision Chief Medical Officer, Harpreet Singh, MD, joins Matthew Hadfield, DO, to share lessons learned and explore how these insights are shaping the future of oncology trials. Watch the full interview to learn more: https://lnkd.in/e9CxCy7Q

Transcript

It is an altruistic activity to enroll on a clinical trial. And so understanding why if you are randomized to the control arm, why it's important to stay with that control arm or stay on the trial. And I think it also goes back to trial design. Let's make sure that our child designs keep the patient at the center. And how do you do that? You do things like offering crossover within the trial design. And that means that if you are randomized. The control arm that if you should progress on that therapy that you immediately what we call crossover or you immediately get access to the drug on the other arm, on the experimental arm. So that's something that I think is helpful. Randomization schemas. So you know, it's like you could consider a 2 to one randomization, for example. Is there a higher chance if you enroll on this trial that you'll get the experimental therapy and also just I think from a regulatory standpoint around the world. Basically reevaluating how much data is needed to make regulatory decisions and on what endpoints. So could any work be done around assuring ourselves and assuring regulatory bodies that early promising results will in fact result in benefit on the time to have an endpoint? It's also very important to not get like super hyped up before there's actual randomized data because I mean there is there is potential for harm to patients when something may not actually be as promising. As we hope it is.

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The accelerated approval of sotorasib for KRAS-mutated lung cancer sparked critical discussions about dosing, trial design, and patient-centered care. Precision Chief Medical Officer, Harpreet Singh, MD, joins Matthew Hadfield, DO, to share lessons learned and explore how these insights are shaping the future of oncology trials. Watch the full interview to learn more: https://lnkd.in/e9CxCy7Q
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27 days to go! Join the precision oncology webinar on the 30th April. Learn how to tackle the challenges of biomarker testing for lung and prostate cancer. BOOK YOUR PLACE NOW HERE: https://ow.ly/91E650R6CeC Topics of conversation include: > An overview of common challenges related to biomarker testing > Addressing the challenges of biomarker testing for lung and prostate cancer throughout the patient journey > A panel discussion amongst speakers and participants engaging in a Q&A to address pressing issues Association for Molecular Pathology (AMP) endorsed #MedEd #MedicalEducation

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