Two of Three Patients Achieve Remission in Chimeric’s AML Trial
Chimeric Therapeutics reports encouraging interim results from its ADVENT-AML Phase 1B trial, with two of three newly diagnosed AML patients achieving remission using their novel CORE-NK cell therapy combined with standard treatment.
- Two of three evaluable patients achieved Complete Response with incomplete blood count recovery (CRi)
- ADVENT-AML is the first frontline AML trial incorporating cell therapy
- Trial targets elderly or unfit AML patients ineligible for chemotherapy or transplant
- No safety concerns observed in dose-finding phase
- Enrollment ongoing at MD Anderson Cancer Center, expected completion by December 2025
A New Frontier in AML Treatment
Chimeric Therapeutics (ASX:CHM) has unveiled promising early data from its ADVENT-AML Phase 1B clinical trial, marking a significant milestone in the treatment of Acute Myeloid Leukemia (AML). This trial is pioneering the use of their proprietary CORE-NK cell therapy combined with the established AML drugs Azacitidine and Venetoclax, targeting patients newly diagnosed with AML who are unsuitable for intensive chemotherapy or stem cell transplantation.
The trial, conducted at the renowned MD Anderson Cancer Center, has so far treated three patients under this frontline protocol. Impressively, two of these patients have achieved Complete Response with incomplete blood count recovery (CRi), a meaningful indicator of remission, while the third patient’s disease has stabilized. These outcomes suggest a potential breakthrough for a patient group with limited treatment options.
Trial Design and Significance
ADVENT-AML is notable for being the first clinical trial to integrate cell therapy as a frontline treatment in AML. The study focuses on older or medically unfit patients who cannot undergo standard chemotherapy or allogeneic stem cell transplant, a demographic that historically faces poor prognoses. The trial’s design includes a dose escalation phase, which concluded without safety issues, followed by a dose expansion phase currently enrolling patients.
Chimeric’s CORE-NK cells are "off-the-shelf" natural killer cells manufactured at Case Western Reserve University, designed to enhance the immune system’s ability to target and destroy cancer cells. By combining these cells with Azacitidine and Venetoclax, the trial aims to harness a synergistic effect that could improve remission rates and survival outcomes.
Expert Perspectives and Next Steps
Dr. Rebecca McQualter, CEO of Chimeric Therapeutics, expressed optimism about the early results, highlighting the trial’s potential to redefine initial AML therapy. Meanwhile, Principal Investigator Dr. Abhishek Maiti at MD Anderson emphasizes the innovative nature of this approach and its promise for patients who previously had few effective options.
The trial commenced in December 2024 and is expected to complete enrollment by the end of 2025. While the initial cohort is small, the early efficacy signals and safety profile provide a strong foundation for further investigation. The company’s broader pipeline, including other CAR-T and NK cell therapies, positions it well within the competitive and rapidly evolving oncology cell therapy landscape.
Broader Implications for AML Treatment
If these early results hold in larger cohorts, Chimeric’s approach could represent a paradigm shift in AML treatment, especially for patients who are elderly or have comorbidities that preclude aggressive therapies. The integration of cell therapy into frontline regimens may open new avenues for durable remissions and improved quality of life.
Bottom Line?
Chimeric’s ADVENT-AML trial is setting the stage for a potential new standard in frontline AML therapy, with early data warranting close attention.
Questions in the middle?
- Will the promising CRi rates sustain in a larger patient cohort?
- How will the safety profile evolve as more patients are treated?
- Can CORE-NK therapy improve overall survival compared to current standards?
