Video content is prompted by the following:
Lessons From Recent Clinical Trials
Key Discussion Points:
- Biomarker-Driven Treatment Selection
- Current challenge of selecting from multiple approved therapies with overlapping biomarkers
- Need for predictive power of biomarkers beyond simple positivity (eg, understanding implications of HER2 2+ vs folate medium expression)
- Sequencing implications of therapies with overlapping toxicity profiles
- Treatment Sequencing Considerations
- Critical importance of first therapy selection in platinum-resistant setting given patient drop-off with subsequent lines
- Limited understanding of how different biomarkers interact (BRCA, HRD, CCNE1, HER2, folate receptor)
- Patient-specific factors influencing treatment selection beyond biomarker status
- Evolution of Clinical Trial Design
- Moving away from “spray and pray” approaches with all-comers to biomarker-driven selection
- Learning from past experiences with immunotherapy trials that enrolled thousands without clear biomarker strategy
- Need for smarter trial designs that enable more precise patient selection
Notable Insights:
- “Which one do I start with? Do I start with trastuzumab deruxtecan or do I start with mirvetuximab and bevacizumab?... Right now, we’re guessing.”
- “We’ve said forever, ‘We don’t have mutations, and we don’t have anything to target.’ We have a lot of things to target. We just are at the early days of figuring out what it means.”
- “3,000-plus patients exposed to 4 different sponsors’ frontline studies of immunotherapy and PARP...can’t do that again...I think we’ve learned that lesson, and we’re going to do better moving forward.”