CSPC's Innovative Drug Research Results Selected for the 2022 ASH Annual Meeting

December 14, 2022

The American Society of Hematology (ASH) Annual Meeting will be held in New Orleans, USA, December 10~13, 2022. As the world's largest professional society on the etiology and treatment of blood disorders, the ASH Annual Meeting is one of the largest and most comprehensive international academic events in the field of hematology worldwide.

Mitoxantrone hydrochloride liposome (PLM60), the world's first mitoxantrone nanomedicine developed independently by CSPC, has once again demonstrated good anti-tumor activity. The results of a phase Ib clinical study on the combination of mitoxantrone hydrochloride liposome injection for the treatment of primary peripheral T-cell lymphoma, led by Prof. Huang Huiqiang from the Center for Cancer Control and Prevention, Sun Yat-sen University, were presented in the form of a poster (No. 1632) at the 2022 ASH Congress.

This is a multi-center Phase Ib clinical study (NCT04548700) designed to evaluate the safety, efficacy, and pharmacokinetics of PLM60 combination therapy in subjects with primarily treated peripheral T-cell lymphoma.

As of June 23, 2022, a total of 26 subjects were enrolled, which included subjects with different pathological subtypes of peripheral T-cell lymphoma, none of whom experienced dose-limiting toxicity events. After a median follow-up of 10.8 months, 25 subjects could be evaluated for efficacy, with CR rates and ORRs of 52.0% (13/25, 95% CI 31.3-72.2%) and 84.0% (21/25, 95% CI 63.9-95.5%) for the overall population, respectively. Efficacy was observed for different pathological subtypes.

Preliminary results showed significant efficacy of the PLM60 combination treatment with different pathological subtypes. PLM60 is safely tolerated within the dose range administered and is currently undergoing a dose expansion phase study.

About Mitoxantrone Hydrochloride Liposomes

Duoenda® (Mitoxantrone Hydrochloride Liposome Injection) is the world's first mitoxantrone nano-liposome formulation developed by CSPC. It is currently approved for use in patients with relapsed/refractory peripheral T-cell lymphoma. In addition to the current ASH report data in initial peripheral T-cell lymphoma, the product has shown significant efficacy in several tumor types, including ovarian cancer, head and neck squamous carcinoma, breast cancer, and extranodal nasal type NK/T-cell lymphoma. In addition, applications in the field of neuroinflammation are being actively explored.

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