Erika Hamilton, MD, from the Sarah Cannon Research Institute in Nashville, TN, presents findings from the Phase I/II study (NCT03250676) of H3B-6545 in women with locally advanced/metastatic estrogen receptor(ER)-positive, HER2-negative breast cancer. H3B-6545 is a novel selective ER covalent antagonist (SERCA) aimed at treating women with advanced/metastatic ER-positive, HER2-negative breast cancer who have progressed on standard therapy. The study revealed promising results, with H3B-6545 demonstrating a low rate of grade ≥3 treatment-emergent adverse events (TEAEs) and showing clinically meaningful antitumor activity in heavily pretreated patients. Notably, the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) was determined to be 450 mg, with an objective response rate (ORR) of 20.2% and a median progression-free survival (PFS) of 5.06 months. These findings suggest that H3B-6545 holds potential as a therapeutic option for this patient population. This interview took place during the 2024 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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