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Bisantrene shows promise as treatment in relapsed or refractory acute myeloid leukaemia patients who have run out of options<\/strong> Special Report:<\/em><\/strong> \u00a0Race Oncology\u2019s latest Phase II study results is giving hope to relapsed or refractory Acute Myeloid Leukaemia (R\/R AML) patients running out of options after failed treatments and transitioning to palliative care. <\/strong>\u00a0<\/strong><\/p>\n Race Oncology (ASX:RAC)<\/strong><\/a> has announced positive interim clinical results from an ongoing investigator-initiated Phase II study of its core asset bisantrene in combination with fludarabine and clofarabine in R\/R AML patients.<\/p>\n The trial abstract has been peer-reviewed and the interim results selected for presentation at the prestigious American Society of Hematology 65th Annual Conference in December.<\/p>\n The oral poster presentation titled Bisantrene in combination with fludarabine and clofarabine as salvage therapy for adult patients with relapsed or refractory acute myeloid leukemia (AML) \u2013 an open-label, phase II study<\/em> \u00a0describes clinical results from the first 15 evaluable patients treated on study since August 2021.<\/p>\n Bisantrene is a unique product that is a small molecule, anthracene-based chemotherapeutic that has anti-cancer benefits but additionally reduced cardiotoxicity, meaning it is less likely to cause heart dysfunction.<\/p>\n In combination with fludarabine and clofarabine, bisantrene administered over four days induced a clinical response in 6 of 15 evaluable patients (40%) with a median age of 48 (range 19-69) with advanced (R\/R AML).<\/p>\n Five of the six treatment-responsive patients were well enough to receive a potentially curative bone marrow transplant within one to three months of treatment.<\/p>\n Of the five-bone marrow transplanted patients, three have since died with one from graft-versus-host disease, another relapsed within four months of transplant, and the third from infection after two years. The two other patients remain disease free and in complete remission.<\/p>\n \u00a0<\/p>\n RAC executive director Dr Pete Smith says AML patients who fail many lines of treatment are likely to be only offered palliative care as many clinicians believe the risks of using more experimental treatments exceed the chance of the patient responding.<\/p>\n He says many clinicians would consider even a single patient being able to be bridged to a bone marrow transplant a success in such a heavily pre-treated population.<\/p>\n \u201cThis is a patient group that normally would not be treated in Australia and clinicians would have given up by now,\u201d Smith says.<\/p>\n \u201cThey have failed an average of four lines of therapy, so they tried some drug or drug combination then maybe had a response but stopped responding then went on something else.\u201d<\/p>\n Smith says outlook for the patients in the trial without treatment was \u201cdire\u201d with a life expectancy measured in weeks if they do not receive efficacious treatment.<\/p>\n He says to take this patient population and put them on the bisantrene drug combination and see it relatively well tolerated and 40% responding with five having a complete response is \u201cquite frankly amazing\u201d.<\/p>\n \u00a0<\/p>\n The trial is running at the Sheba Medical Centre in Israel, under the supervision of key opinion leader Professor Arnon Nagler.<\/p>\n \u201cThese rather impressive results in such a heavily pre-treated population support further studies of bisantrene-based combinations, including those with venetoclax or hypomethylating agents,\u201d Nagler says in the trial abstract.<\/p>\n Calvary Mater Newcastle and John Hunter Hospitals director of haematology Professor Dr Anoop Enjeti, who was not involved in the study, says it \u201cproduced very encouraging results in younger AML patients\u201d.<\/p>\n \u201cMany of these patients achieved a complete or a partial remission, enabling a significant proportion to go on to a bone marrow transplant,\u201d he says.<\/p>\n \u201cThese impressive results provide proof of concept supporting further trials of bisantrene in combination with other AML treatments to improve outcomes for this leukaemia.\u201d<\/p>\n \u00a0<\/p>\n Smith says the positive trial data will help progress bisantrene as a treatment for patients that are more likely to respond.<\/p>\n \u201cAll new oncology drugs and drug combinations start out in the hardest to treat patients with the most advanced disease.<\/p>\n \u201cAs clinical understanding grows around a drug\u2019s efficacy and side-effects, clinicians will start to use the drug in earlier-stage patients who are more likely to respond to treatment.\u201d<\/p>\n Furthermore, he says the positive clinical trial data is the foundation of commercialisation or partnership discussions with large pharmaceutical companies.<\/p>\n \u201cRace continues to engage with potential pharma partners and will update the market on progress when appropriate,\u201d he says.<\/p>\n \u201cIt\u2019s still early days in terms of digesting this data and working out the path forward but very encouraging.\u201d<\/p>\n \u00a0<\/p>\n Race is considering a range of clinical options for the use of bisantrene in the AML setting and is in advanced discussions with clinicians in Australia and internationally.<\/p>\n \u201cAny future trials we need to think about,\u201d Smith says.<\/p>\n \u201cProfessor Nagler has put a lot into trials, more than one with Race, and it\u2019s an investigator-led trial not a company-sponsored sponsored trial, which is worth emphasising.\u201d<\/p>\n Smith says RAC is in the process of getting treatment into Israel for the final patient on the study protocol.<\/p>\n \u201cObviously, we will need to be realistic about whatever situation is going on in Israel and hopefully everyone is safe there and the hospital is unaffected.\u201d<\/p>\n \u00a0<\/p>\n This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post Race Oncology releases \u2018striking\u2019 interim Phase 2 AML trial results<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"
\nIn combination with fludarabine and clofarabine, bisantrene induced a clinical response in 40% of evaluable patients<\/strong>
\nInterim results selected for presentation at American Society of Hematology 65th Annual Conference<\/strong><\/p>\nPalliative patients responding \u2018quite frankly amazing\u2019<\/strong><\/h2>\n
\u2018Very encouraging results in younger AML patients\u2019<\/strong><\/h2>\n
Moving bisantrene into less advanced AML patients <\/strong><\/h2>\n
Monitoring events in Israel<\/strong><\/h2>\n