Eli Lilly & Co’s (NYSE: LLY) Retevmo (selpercatinib) has been officially launched in the Chinese market. The drug is being commercialized by domestic firm Innovent Biologics Inc. (HKEX: 01801) under a partnership deal signed between the two companies in March last year. This collaboration aims to bring innovative treatments to patients in China, leveraging Innovent’s local expertise and market presence.
Drug Approval and Indications
Retevmo was first approved in the US in May 2020 and subsequently received conditional approval in China for use in RET-mutated advanced or metastatic medullary thyroid cancer (MTC) in adults and children aged 12 years and older, as well as RET gene fusion-positive adults and children aged 12 years and older with advanced or metastatic thyroid cancer (TC). The March 2022 deal between Lilly and Innovent covered up to three Lilly drugs for the mainland China market, including Cyramza (ramucirumab) and Retevmo.
Clinical Trial Data and Efficacy
The approval of Retevmo in China was based on 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 disease (DoR) as primary endpoints. The study demonstrated that Retevmo had a higher response rate and longer duration in patients with locally advanced or metastatic NSCLC with positive RET fusion, patients with late or metastatic MTC with RET mutation, and patients with advanced or metastatic TC with positive RET fusion.
LIBRETTO-321, a multi-center Phase II study, was designed to assess the efficacy and safety of Retevmo in Chinese patients with RET mutant advanced solid tumors. The study enrolled 77 Chinese patients with RET gene mutation advanced solid tumors, including 47 patients with RET fusion-positive advanced NSCLC, 29 patients with RET mutation advanced MTC, and 1 patient with RET fusion-positive advanced TC. The results showed that the Chinese data were highly consistent with the global data from LIBRETTO-001, validating the good efficacy and safety of Retevmo in the Chinese population.
Future Prospects
The launch of Retevmo in China represents a significant milestone for both Eli Lilly and Innovent Biologics. By bringing this innovative treatment to the Chinese market, the companies aim to improve patient outcomes and address significant unmet medical needs in the treatment of RET-driven cancers. The successful commercialization of Retevmo, along with other drugs under the partnership, positions the companies to make a meaningful impact on the oncology treatment landscape in China.-Fineline Info & Tech
