Race Oncology's Bisantrene Shows Promise in Phase 2 AML Trial
RAC (RAC) Share Update July 2024 Monday 29th
Race Oncology Announces Successful Phase 2 Trial of Bisantrene for AML
Race Oncology Limited (ASX: RAC) has announced the successful conclusion of its Phase 1b/2 trial of bisantrene for relapsed or refractory acute myeloid leukemia (R/R AML), achieving its primary efficacy endpoint.
Instant Summary:
- Phase 1b/2 trial of bisantrene in combination with clofarabine and fludarabine was successfully concluded.
- 40% of patients with highly advanced disease showed a response to the treatment.
- The trial surpassed the predefined efficacy goal of at least 3 complete responses.
- Race Oncology plans to initiate a new Phase 1/2 trial using RC220 bisantrene.
Study Design and Results
The Phase 1b/2 trial of bisantrene, conducted at the Chaim Sheba Medical Centre in Israel, investigated the combination of bisantrene, clofarabine, and fludarabine (Bis/Clo/Flu) in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The study was led by Professor Arnon Nagler, a key opinion leader in AML.
The trial was designed in two stages: a Phase 1b dose-escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), and a Phase 2 expansion stage to determine the efficacy and confirm the safety of the Bis/Clo/Flu regimen. The Phase 1b stage used a 3+3 design, enrolling patients in cohorts to receive the treatment for four consecutive days.
In the Phase 2 stage, up to 17 patients were enrolled using a Simon's 2-stage design. The trial aimed to achieve at least 3 complete responses to reject the null hypothesis of no clinical benefit. The study concluded with 6 out of 15 evaluable patients (40%) responding to the treatment, including 5 complete responses and 1 partial response, surpassing the efficacy goal.
Impact on Future Studies
The successful results of this trial strongly support Race Oncology's intention to initiate a new Phase 1/2 investigator-sponsored AML trial using RC220 bisantrene. The interim results were presented at the American Society of Hematology (ASH) Annual Conference, and the final outcomes are expected to be published in a high-impact peer-reviewed journal later in 2024.
Race Oncology CEO, Dr. Daniel Tillett, expressed gratitude to Professor Nagler and his team for their dedication and commitment to the study. The trial's positive results have stimulated further clinician interest in bisantrene, paving the way for future AML clinical studies.
The successful Phase 2 trial results are likely to have a positive impact on Race Oncology's stock, as the efficacy of bisantrene in treating R/R AML patients has been demonstrated. This could lead to increased investor confidence and interest in the company's future clinical studies.
Investor Reaction:
Analysts are expected to react positively to the trial's success, as it not only meets but exceeds the predefined efficacy criteria. The potential for bisantrene to be used in future AML trials could drive further interest and investment in Race Oncology.
Conclusion:
Investors should keep an eye on Race Oncology's upcoming Phase 1/2 trial using RC220 bisantrene and the final publication of the study outcomes. The company's strategic advancements in AML treatment could present significant opportunities for growth and investment.