HCM News & Events

Hutchmed (HCM) announced an update regarding Tazverik, an oncology therapy licensed from Epizyme, an Ipsen (IPSEY) company, in China. Epizyme is the marketing authorization holder of Tazverik in the Chinese mainland, for which Hutchmed acts as the domestic agent/licensee. Ipsen has informed Hutchmed that it is voluntarily withdrawing Tazverik in the U.S. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, Hutchmed has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options. Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial. As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing Tazverik effective immediately, including both for follicular lymphoma and epithelioid sarcoma. Ipsen has announced that, in addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the FDA on the next steps to execute the withdrawal of Tazverik and provide all necessary information to complete this process.

Hutchmed (HCM) reported that results from the SACHI Phase III trial were published in The Lancet. SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer with MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor therapy. Savolitinib is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca (AZN) and Hutchmed and commercialized by AstraZeneca. Osimertinib is a third-generation, irreversible EGFR TKI. Based on interim data from SACHI, the savolitinib and osimertinib combination was granted regulatory approval in China in June 2025.