Race Oncology’s Bisantrene Trial Surpasses Efficacy Goals in Tough AML Cases
Race Oncology’s Phase 1b/2 trial of RC110 bisantrene for relapsed or refractory acute myeloid leukemia has demonstrated a 40% response rate, exceeding expectations and offering new hope for difficult-to-treat patients.
- 40% response rate in relapsed/refractory AML patients
- Five complete and one partial response achieved
- One patient remains disease-free over two years post-treatment
- Trial results published in British Journal of Haematology
- Supports further clinical development of bisantrene
A Promising Step in AML Treatment
Race Oncology Limited has announced the publication of the final results from its Phase 1b/2 clinical trial investigating RC110 bisantrene combined with clofarabine and fludarabine for patients with relapsed or refractory acute myeloid leukemia (AML). Conducted at the Sheba Medical Centre in Israel under the guidance of Professor Arnon Nagler, the study’s findings were featured in the British Journal of Haematology, a respected peer-reviewed journal in the field.
The trial enrolled adult patients with highly advanced AML who had limited treatment options. The combination therapy, administered intravenously, achieved a 40% clinical response rate, including five complete responses and one partial response. This outcome notably surpassed the trial’s predefined efficacy threshold, which required at least three complete responses to demonstrate clinical benefit.
Clinical Impact and Patient Outcomes
Among the responders, five patients proceeded to potentially curative stem cell transplants shortly after treatment. While three of these patients unfortunately succumbed to complications such as graft-versus-host disease, relapse, or infection, one patient remains alive and disease-free more than two years post-treatment. This long-term remission in a heavily pretreated population underscores the potential of bisantrene as a meaningful therapeutic option.
The trial’s design included a dose-escalation phase to establish the recommended Phase 2 dose, followed by an expansion phase to evaluate efficacy and safety. The positive results build on prior Phase 2 monotherapy data for bisantrene, reinforcing its promise in AML treatment.
Looking Ahead for Race Oncology
Race Oncology’s CEO, Dr Daniel Tillett, expressed gratitude to the Sheba Medical Centre team and the patients involved, highlighting the dedication required to advance new cancer therapies. The company is now positioned to pursue further clinical studies of bisantrene, potentially expanding its use in AML and other oncology indications. With a well-characterized safety profile and less cardiotoxicity compared to some anthracyclines, bisantrene could fill an important niche in cancer care.
As Race Oncology continues to explore partnerships and commercial opportunities, these published results provide a solid foundation for investor confidence and future regulatory engagement.
Bottom Line?
Race Oncology’s encouraging Phase 2 data sets the stage for expanded trials and potential regulatory milestones in AML treatment.
Questions in the middle?
- Will Race Oncology initiate larger Phase 3 trials to confirm bisantrene’s efficacy and safety?
- How will the company address the challenges of transplant-related complications observed in responders?
- What timelines and strategies are in place for regulatory submissions and potential market approval?