New England Journal of Medicine publishes phase 1/II data for Retevmo in Advanced RET-Driven Lung and Thyroid Cancers.- Eli Lilly

Eli Lilly and Company announced that the New England Journal of Medicine (NEJM) published Phase 1/II study results of the registrational trial for Retevmo (selpercatinib), the first and only therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/II trial's endpoints of overall response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. NEJM published separate articles focusing on efficacy and safety data in the RET fusion-positive NSCLC and RET-altered thyroid patient cohorts independently, with data demonstrating durable objective responses across both patient populations. See-"Efficacy of Selpercatinib in RET-Altered Thyroid Cancers"-Lori J. Wirth, M.D., Eric Sherman, M.D., Bruce Robinson, M.D.,., et al.- August 27, 2020. N Engl J Med 2020; 383:825-835 DOI: 10.1056/NEJMoa2005651. See- "Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer".- Alexander Drilon, M.D., Geoffrey R. Oxnard, M.D., Daniel S.W. Tan, M.B., B.S., Ph.D., et al. August 27, 2020 N Engl J Med 2020; 383:813-824. DOI: 10.1056/NEJMoa2005653.