Safety and Efficacy Signals Brighten Outlook for Chimeric’s AML Cell Therapy
Chimeric Therapeutics reports encouraging Phase 1B data from its ADVENT-AML trial, showing safety and multiple complete responses in high-risk AML patients treated with CORE-NK combined with standard therapies.
- 57% clinical response rate in high-risk frontline AML patients
- Two new complete responses added to previous trial results
- No dose-limiting toxicities or severe immune-related side effects observed
- CORE-NK cells persisted in patients’ blood beyond two weeks
- Dose expansion phase enrolling up to 20 newly diagnosed AML patients
Clinical Progress in AML Treatment
Chimeric Therapeutics (ASX, CHM) has released promising new data from its Phase 1B ADVENT-AML clinical trial, highlighting the potential of its CORE-NK cell therapy in treating acute myeloid leukemia (AML). Presented at the Society of Hematology Oncology Annual Meeting in Houston, the data reveal encouraging safety and efficacy signals in both relapsed/refractory and high-risk frontline AML patients.
The dose escalation phase, completed in late 2024, treated six patients with relapsed or refractory AML using two escalating doses of CORE-NK cells combined with standard AML therapies azacitidine and venetoclax. Importantly, the therapy demonstrated a clean safety profile with no dose-limiting toxicities, cytokine release syndrome, neurotoxicity, or graft-versus-host disease. One patient achieved a complete response, and the CORE-NK cells were detectable in the bloodstream for over two weeks following repeated infusions.
Encouraging Responses in Newly Diagnosed Patients
Beyond the dose escalation cohort, the ongoing frontline cohort enrolling high-risk newly diagnosed AML patients has reported four clinical responses among seven evaluable subjects. These include two complete responses, one complete response with incomplete count recovery, and one partial response. The combination therapy continues to be well tolerated, with no unexpected safety concerns emerging.
This frontline cohort is actively enrolling patients at leading US institutions including The University of Texas MD Anderson Cancer Center and Case Western Reserve University. The trial is now expanding to enroll up to 20 patients who are ineligible for intensive chemotherapy or stem cell transplant, a group that historically faces limited treatment options.
Implications for Cell Therapy in AML
Chimeric’s CORE-NK platform represents a novel approach leveraging natural killer cells, which are part of the immune system’s frontline defense against cancer. The ADVENT-AML trial is the first to evaluate the synergy of CORE-NK cells combined with azacitidine and venetoclax, the current standard of care for AML. The early data suggest this combination could enhance treatment efficacy while maintaining a manageable safety profile.
Jason B Litten, Chimeric’s Chief Medical Officer, expressed optimism about the findings, emphasizing the scientific validation this trial provides for the novel combination. The company is eagerly awaiting results from the dose expansion phase, which could potentially change clinical practice for elderly or infirm AML patients.
Chimeric Therapeutics continues to advance a diversified pipeline of cell therapies, including CAR T and next-generation NK cell products, positioning itself at the forefront of innovation in oncology.
Bottom Line?
As Chimeric advances its ADVENT-AML trial, the next phase could redefine treatment for vulnerable AML patients.
Questions in the middle?
- Will the dose expansion phase confirm the early efficacy signals in a larger patient group?
- How will CORE-NK therapy compare to emerging AML treatments in terms of long-term outcomes?
- What regulatory hurdles remain before CORE-NK can become a standard frontline therapy?
