Race Oncology Ltd (ASX:RAC) has fielded “impressive” Phase 2 clinical trial results from its Acute Myeloid Leukaemia (AML) clinical trial.
The interim clinical results are from an ongoing investigator-initiated Phase 2 trial of bisantrene in combination with fludarabine and clofarabine in relapsed or refractory acute myeloid leukaemia patients.
Bisantrene in combination with fludarabine and clofarabine administered over four days induced a clinical response in 40% evaluable patients with advanced relapsed or refractory acute myeloid leukaemia (R/R AML), with five patients receiving a potentially curative stem cell transplant.
The bisantrene combination was found to be safe and well tolerated without clinically relevant cardiotoxicity or tumour lysis syndrome.
"Striking" responses
“To see such meaningful clinical responses in a group that would typically be receiving palliative care is striking," said Race executive director Dr Pete Smith.
"It is also encouraging that the safety profile was manageable, even for this advanced patient population.
"These are highly positive outcomes in a heavily pretreated patient population,”
Race will present its impressive Acute Myeloid Leukaemia clinical trial results at the 65th American Society of Hematology Annual Conference next month.
Highly positive interim results
Of the 15 evaluable patients, six responded to bisantrene/clofarabine/fludarabine treatment, with five complete responses and one partial response, with three of the clinical responders having active extramedullary disease (EMD).
Five of the six treatment-responsive patients were able to be bridged to a stem cell transplant within one to three months of treatment.
Of the five stem cell transplanted patients, three have since died; one from graft-versus-host disease, one who relapsed within four months of transplant, and one of infection after two years.
The two other patients remain disease-free and in complete remission.
The trial is running at the Sheba Medical Centre, Israel, under the supervision of key opinion leader Professor Arnon Nagler.
Professor Nagler concludes in the abstract: “These rather impressive results in such a heavily pre-treated population support further studies of bisantrene-based combinations, including those with venetoclax or hypomethylating agents."
American Society of Hematology conference
The trial abstract has been peer-reviewed and the interim results have been selected by the conference committee for presentation at the prestigious American Society of Hematology 65th Annual Conference, December 9-12, 2023.
The oral poster presentation — 'Bisantrene in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) – An Openlabel, Phase II Study' — describes clinical results from the first 15 evaluable patients treated on study since August 2021.
The presentation abstract was released from embargo by ASH on November 2, 2023.
Positive trial response
While not involved with the Sheba study, independent specialist Professor Dr Anoop Enjeti, director of Haematology at the Calvary Mater Newcastle and John Hunter Hospitals spoke positively of the interim results.
"This clinical trial of bisantrene in combination with intensive chemotherapy produced very encouraging results in younger AML patients with advanced relapsed, refractory and resistant acute myeloid leukaemia (AML).
“Many of these patients achieved a complete or a partial remission, enabling a significant proportion to go on to a bone marrow transplant. These impressive results provide proof of concept supporting further trials of bisantrene in combination with other AML treatments to improve outcomes for this leukaemia."
Professor Enjeti is a highly experienced clinical haematologist, having designed and led more than 25 clinical trials and is the co-chair of the MDS/AML working party for the Australasian Lymphoma and Leukemia Group for Cooperative Clinical Trials.