肉瘤新药-他泽司他(Tazemetostat)

Epithelioid sarcoma (ES) is a rare soft tissue malignant tumor with unknown tissue origin and slow progression. It accounts for about 1% to 5% of all soft tissue malignant tumors. It occurs in young adults, mostly in men, and has a high recurrence and metastasis rate. The pathological characteristics of ES are epithelioid cells forming nodules, most (>90%) of which are accompanied by loss of INI1 functional protein (expressed by the tumor suppressor gene INI1), and mostly express cytokeratin (CK), epithelial membrane antigen (EMA) and CD34. Due to insensitivity to radiotherapy and chemotherapy, surgical treatment (radical and extended resection) is still the main method for the treatment of ES. , trade name: Tazverik, this drug is a zeste gene enhancer homolog 2 (EZH2) inhibitor developed by Epizyme Biopharmaceutical Company in the United States. It was approved for accelerated marketing by the U.S. Food and Drug Administration (FDA) on January 23, 2020. It has also become the world's first new drug on the market for the targeted treatment of ES.

An open-label, single-arm, multi-center phase II clinical trial (NCTO2601950, EZH-202 study) is ongoing to evaluate the efficacy and safety of tazerestat in the treatment of specific types of tumors (INI1 functional protein loss) or relapsed/refractory synovial sarcoma. The study results showed that the median follow-up time of 62 ES patients was 14 months (0.4~31 months), the objective response rate (ORR) was 15% (95%CI: 7%~26%), of which the complete response (CR) rate and partial response (PR) rate accounted for 1.6% and 13% respectively; the sustained response time (DOR) ranged from (3.7 to 24.5) months, of which 67% of patients had DOR ≥ 6 months. It is based on this research result that tazerestat was successfully launched through accelerated approval.

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