Race Oncology (ASX:RAC) has announced that the investigator-sponsored Phase 1b/2 trial of bisantrene in combination with clofarabine and fludarabine in relapsed or refractory acute myeloid leukaemia (R/R AML) patients has been published in the peer-reviewed British Journal of Haematology.
The trial was conducted at the Chaim Sheba Medical Centre in Israel under the supervision of AML key opinion leader Professor Arnon Nagler.
Six of the 15 evaluable patients (40 per cent) in the Phase 2 efficacy stage showed a clinical response to the treatment, with three of these responders having active extramedullary disease. Five of the six treatment-responsive patients were transitioned to a potentially curative stem cell transplant within one to three months of receiving treatment.
Of the five stem-cell transplanted patients, three have since died. One died from graft-versus-host disease after transplant, one from disease relapse four months after transplant, and one from infection after treatment. One patient remains alive and free of disease more than two years after treatment with the bisantrene combination.
Race said the patient complete response rate met the trial’s prespecified two-stage Simon efficacy threshold of three or more complete responses.
Race Oncology CEO, Dr Daniel Tillett, said, “I would like to extend my sincere thanks to Professor Nagler and his dedicated team at the Chaim Sheba Medical Centre, who have spent the last 6 years meticulously investigating the utility of bisantrene for patients with relapsed/refractory Acute Myeloid Leukaemia. The Sheba team’s dedication and commitment has added to the strong historical evidence of the efficacy of bisantrene in treating patients with AML. We extend our gratitude to all patients and their families whose participation make the development of new AML treatments such as bisantrene possible.”