Myeloblasts with Auer rods seen in Acute Myeloid Leukemia (AML), advanced stage. Credit: Paulo Henrique Orlandi Mourao.

Tolero Pharmaceuticals has dosed the first patient in a Phase II Zella 202 study of investigational agent alvocidib.

The study will assess the efficacy and safety of alvocidib in patients with acute myeloid leukaemia (AML) who have either relapsed from or are refractory to venetoclax in combination with a hypomethylating agent (HMA).

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The open-label, randomised study will be conducted in two parts at sites in the US.

The primary endpoint of the trial is to identify the rate of combined complete remission (CR) and CR with incomplete hematological recovery (CRi) of alvocidib as a monotherapy and in combination with low-dose cytarabine in patients with AML.

Secondary endpoints include determining the recommended regimen, evaluating the median overall survival (mOS) and CR rate among others.

Tolero Pharmaceuticals CEO David J Bearss said: “Patients with AML who are resistant to or progressed following treatment with the BCL-2 inhibitor venetoclax in combination with an HMA have limited treatment options, and it has been well established in the literature that a key potential mechanism of resistance to BCL-2 targeted therapy is the switch to a dependence on MCL-1.

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“The initiation of this study marks an important step toward understanding the potential of alvocidib as a monotherapy or in combination with low-dose cytarabine for these patients.”

Alvocidib is an investigational inhibitor of cyclin-dependent kinase 9 (CDK9). The candidate is also being tested in combination with venetoclax under a Phase I study in patients with relapsed or refractory AML.

Zella 101 and Zella 102 clinical studies, evaluating the efficacy of Alvocidib, are also underway.