Laura Alder, Thoracic Medical Oncologist at Duke University School of Medicine, shared a post by Neil Vasan, Director of Breast Cancer Translational Research at NYU Langone Health, on X, adding:
“SERENA-6 showed that ctDNA-guided switching before radiographic progression can extend PFS in breast cancer.
Worth remembering that lung cancer already ran a similar study: -APPLE (EORTC LCG-1613) monitored plasma T790M on gefitinib and switched to osimertinib at molecular progression.
Median PFS was comparable to switching at radiographic progression (22.0 vs 20.2 mo); only 17% of patients ever switched on ctDNA before their scans changed. -The 6–3 ODAC vote and Neil Vasan highlights the dilemma: nobody doubts the drug works, the question is whether acting at molecular progression beats waiting for the scan. Same idea, different tumor, still unsettled…”
Quoting Neil Vasan:
“FDA granted accelerated approval for camizestrant today based on SERENA-6: switching therapy when an ESR1 mutation appears in ctDNA, before scans show progression. This is resistance defined, drugged, and tracked at the bedside.
I served as Chair of the Oncologic Drugs Advisory Committee (ODAC) on this trial. My recent JAMA piece discussed the vote and regulatory issues around detecting cancer before it is seen.”
You can also read:
Discussions Around the FDA Approval of Camizestrant Based on the SERENA-6 Trial
