Policy & Regulation
Tolero Pharmaceuticals Releases Clinical Data for Investigational Alvocidib in AML Treatment
21 June 2018 - - Lehi, Utah-based hematological disease treatment developer Tolero Pharmaceuticals, Inc. has tabulated preliminary data from Zella 201, an ongoing Phase 2 study evaluating the efficacy and safety of alvocidib, an investigational small molecule cyclin-dependent kinase 9 (CDK9) inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory myeloid cell leukemia 1 (MCL-1) dependent acute myeloid leukemia (AML), the company said.
Preliminary data from Stage 1 of the study indicated alvocidib in combination with cytarabine and mitoxantrone has shown encouraging activity in 18 patients with MCL-1-dependent AML, with the majority of patients achieving a complete remission (CR) or complete remission with incomplete recovery (CRi).
The study found an overall CR/CRi rate of 61% and an overall response rate (ORR) of 67%. In patients who were refractory to frontline therapy, CR/CRi rate was 75% and ORR was 88%. Patients that attained a CR/CRi experienced a median duration of response of 8.2 months and median overall survival of 10.1 months.
In addition, 44% of patients proceeded to post-study stem cell transplant, including 63% of previously refractory patients.
Tolero is a clinical-stage biopharmaceutical company researching and developing treatments for patients with oncological and hematological diseases.
Its diverse pipeline targets biological drivers of blood disorders to treat leukemias, anemia, and solid tumors, as well as targets of drug resistance and transcriptional control. Tolero, based in the United States, is a wholly owned subsidiary of Japan-based Sumitomo Dainippon Pharma Co., Ltd.
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