Phase II Bisantrene trial data published in European Journal of Haematology

10 November 2020 – Race Oncology Limited (ASX: RAC) is pleased to report that the clinical data from the investigator initiated Phase II clinical trial of Bisantrene in relapsed and refractory Acute Myeloid Leukaemia (R/R AML), conducted at Israel’s Sheba Medical Centre has been published.

This open label, single agent trial, led by Professor Arnon Nagler, studied patients (n=10) with relapsed or refractory Acute Myeloid Leukaemia (R/R AML) who on average had failed three prior lines of treatment. Bisantrene was found to be well tolerated, and after only a single course of treatment, an overall clinical response rate of 40% was observed (ASX Announcement: June 16 2020).

The paper, entitled A phase II study of Bisantrene in patients with relapsed/refractory acute myeloid leukemia by Canaani et al. concludes:

“…bisantrene induced clinical responses in 4 of 10 patients with R/R AML with acceptable toxicity. Bisantrene is somewhat similar to Thiotepa and Treosulfan in that an old drug that is being now revisited gaining a lot of interest especially due to better understanding of its intracellular mechanism of action blocking FTO, a recently discovered key factor in leukomogenesis. Further studies are needed to make evidence-based conclusions regarding the candidate role of bisantrene in AML therapeutics. While interventions targeting FLT3, IDH1, IDH2, and hedgehog signalling provide new hope, traditional cytotoxic chemotherapy retains a critical role in AML patient management. We speculate that bisantrene-based chemotherapy may have its greatest applicability to patients with extramedullary disease given the marked activity here observed with leukemia cutis, chloromas, and CNS disease. Our data reveal a particularly encouraging response in this high-risk population and support additional bisantrene clinical trials in R/R AML patients.

The paper, which has been accepted for publication and has undergone full peer review, is available via the following link:                                     doi.org/10.1111/ejh.13544