Eli Lilly (NYSE:LLY) initiates a Phase 3 clinical trial, LIBRETTO-531, evaluating selpercatinib (LOXO-292) in previously untreated patients with RET-mutation-positive medullary thyroid cancer, a Breakthrough Therapy indication.
The 400-subject study will compare selpercatinib to physician’s choice of Exelixis’ (NASDAQ:EXEL) Cabometyx (cabozantinib) or Sanofi’s (NASDAQ:SNY) Caprelsa (vandetanib) as initial treatment of the cancer.
The primary endpoint is treatment failure-free survival. Secondary endpoints include progression-free survival, overall response rate, overall survival and duration of response.
The estimated primary completion date is February 2023.
The company secured the rights to the RET inhibitor via its acquisition of Loxo Oncology in February.
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