Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid cancer (MTC) in adults and children aged 12 years and older, and RET gene fusion-positive advanced or metastatic thyroid cancer (TC) in adults and children aged 12 years and older.
Partnership and Market Entry
Retevmo was approved in the US in 2020 for RET mutation-driven NSCLC and MTC. A market filing for the drug in China was accepted for review in November 2021 with priority review status. In March this year, Eli Lilly deepened its partnership with China-based Innovent Biologics (HKEX: 01801), signing a licensing deal to commercialize up to three Lilly drugs in mainland China, including exclusive rights to both Cyramza (ramucirumab) and Retevmo.
Clinical Trial Results and Regulatory Basis
The approval is based on data from the global LIBRETTO-001 study and the Chinese population data from the LIBRETTO-321 study. LIBRETTO-001, a global Phase I/II study, assessed Retevmo in RET-driven cancer patients, with objective response rate (ORR) and median duration of response (DoR) as primary endpoints. The study demonstrated higher response rates and longer durations in patients with locally advanced or metastatic NSCLC with positive RET fusion, late or metastatic MTC with RET mutation, and advanced or metastatic TC with positive RET fusion.
LIBRETTO-321, a multi-center Phase II study, evaluated the efficacy and safety of Retevmo in Chinese patients with RET mutant advanced solid tumors. The study enrolled 77 Chinese patients, including 47 with RET fusion-positive advanced NSCLC, 29 with RET mutation advanced MTC, and one with RET fusion-positive advanced TC. Results showed that the Chinese data were highly consistent with the global LIBRETTO-001 data, validating the drug’s efficacy and safety in the Chinese population.-Fineline Info & Tech
