他泽司他治疗上皮样肉瘤的试验效果怎么样

In clinical trials, tazerestat has shown significant efficacy in the treatment of epithelioid tumors. Tazerestat was well tolerated and showed clinical activity in a cohort of patients with advanced epithelioid sarcoma lacking INI1 or SMARCB1. Tazerestat is an oral, highly selective EZH2 inhibitor that can prolong survival and improve patients' quality of life. With its actual clinical benefits and acceptable AEs, it has been recommended by the 2022 CSCO guidelines for targeted therapy of special pathological subtypes of advanced or unresectable soft tissue sarcoma (epithelioid sarcoma).

Trial data of tazerestat in the treatment of epithelioid sarcoma

This study reports the clinical activity and safety of the oral selective EZH2 inhibitor tazerestat in patients with epithelioid sarcoma.

research methods

In this open-label, phase 2 basket study (NCT02601950), patients from 32 hospitals and clinics in multiple countries around the world with various INI1-negative solid tumors or synovial sarcomas were enrolled in seven cohorts. Patients received 800 mg of tazerestat orally twice daily for 28 days until disease progression, unacceptable toxicity, or withdrawal of consent.

The primary endpoint was investigator-assessed objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints were duration of response, disease control rate at 32 weeks, progression-free survival, overall survival, and pharmacokinetic and pharmacodynamic analyzes (primary results reported separately). Reaction time was also evaluated as an exploratory endpoint.

Research results

Sixty-two patients with epithelioid sarcoma participated in the study and were considered eligible for inclusion in this cohort. All 62 patients were included in the modified intention-to-treat analysis. At the data cutoff date, 9 of 62 patients (15% [95% CI 7-26]) had experienced an objective response. With a median follow-up of 13-8 months (IQR 7-8-19-0), the median duration of response has not been reached (95% CI 9-2 - cannot be estimated). Disease control was achieved at 32 weeks in 16 patients (26% [95% CI 16-39]). Median time to response was 3-9 months (IQR 1-9-7-4). Median progression-free survival was 5-5 months (95% CI 3-4-5-9) and median overall survival was 19-0 months (11-0-not estimable).

Treatment-related effects of tazerestat grade 3 or greater included anemia (four [6%]) and weight loss (two [3%]). Two patients experienced treatment-related serious adverse events (one seizure and one hemoptysis). There were no treatment-related deaths.

Test conclusion

Tazerestat was well tolerated and showed clinical activity in patients with advanced epithelioid sarcoma characterized by INI1/SMARCB1 loss. Tazetostat has the potential to improve outcomes for patients with advanced epithelioid sarcoma.

Where to buy tazetostat

Tazerestat has not been launched in mainland China as of October 2023, and patients cannot buy it in hospital pharmacies in mainland China.

Patients in need can purchase medicines in areas where they are already available with a doctor's prescription, but traveling far away, long distances, high risks, heavy financial burdens, and higher risks in purchasing medicines.

Patients who are inconvenient to travel can also obtain the drugs through the help of domestic professional overseas medical service organizations (such as Medical Companion Travel). They can mail the drugs to their homes and purchase them with a doctor's prescription, which is guaranteed to be genuine, more cost-effective and affordable. However, the price is not fixed due to various factors. It is recommended to consult customer service personnel for specific costs and acquisition procedures, so that access to the drugs is guaranteed.

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References

Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020 Nov;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. Epub 2020 Oct 6. PMID: 33035459.