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Eli Lilly Opens Phase III Trial for RET-Mutant Medullary Thyroid Cancer

NEW YORK – Eli Lilly said on Monday that its Phase III, LIBRETTO-531 clinical trial is enrolling patients with treatment-naïve RET-mutant medullary thyroid cancer. The randomized study will examine the effects of selpercatinib, or LOXO-292, against chemotherapy.

"Approximately 60 percent of people with medullary thyroid cancer have an activating RETpoint mutation, yet the current therapeutic options are not ideal for many patients," Lori Wirth, medical director of the Center for Head and Neck Cancer at Massachusetts General Hospital Cancer Center, and an investigator on the trials, said in a statement.

Selpercatinib is an orally administered drug in clinical development for cancers with abnormalities in the rearranged during transfection (RET) kinase. Cancers with RET fusions depend on this single activated kinase for their proliferation and survival. Selpercatinib is designed to block RET signaling, as well as anticipated resistance mechanisms that cancer cells may acquire.

The trial will evaluate the efficacy of selpercatinib by tracking patients' progression-free survival, treatment failure-free survival, overall survival, overall response rate, and duration of response. Patients in the control arm are allowed to crossover to treatment at disease progression.

Earlier this month, Lilly also opened a Phase III selpercatinib trial in RET fusion-positive non-small cell lung cancer.