CPX-351 +/- gemtuzumab ozogamicin as induction therapy for adult patients with newly diagnosed,
Chezi Ganzel1, Avraham Frisch2, Ofir Wolach3
1Hematology and Bone Marrow Transplantation Department, the Eisenberg R&D Authority, Shaare Zedek Medical Center, and Faculty of Medicine, Hebrew University, Jerusalem, Israel.
Abstract:
This pilot study evaluated CPX-351 in adults with newly diagnosed, favourable-intermediate risk, FLT3-ITD-negative AML. Twenty patients received CPX-351 for induction, with six also receiving gemtuzumab ozogamicin (GO). The complete response rate was 95%, with 42% achieving flow-based minimal residual disease (MRD) negativity post-induction. The 18-month leukaemia-free and overall survival estimates were 80% and 95% respectively. Adding GO appeared safe without prolonged cytopenias. Subclinical cardiotoxicity was observed in 25% of patients. The study demonstrated CPX-351's feasibility, with response and MRD-negativity rates comparable to standard '7 + 3' induction.
Insights
This pilot study shows CPX-351 is a feasible treatment for newly diagnosed acute myeloid leukemia (AML), achieving high response and survival rates comparable to standard induction therapy.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Acute myeloid leukemia (AML) remains a significant challenge, particularly in favorable-intermediate risk, FLT3-ITD-negative subtypes.
- Standard induction chemotherapy, such as '7+3', has limitations and associated toxicities.
- Novel therapeutic strategies are needed to improve outcomes for AML patients.
Purpose of the Study:
- To evaluate the safety and efficacy of CPX-351 in adults with newly diagnosed, favorable-intermediate risk, FLT3-ITD-negative AML.
- To assess the feasibility of combining CPX-351 with gemtuzumab ozogamicin (GO).
- To compare response and survival rates with historical '7+3' induction regimens.
Main Methods:
- Pilot study involving 20 adult patients with newly diagnosed AML.
- Patients received CPX-351 for induction therapy.
- Six patients also received gemtuzumab ozogamicin (GO) in combination.
Main Results:
- A high complete response rate of 95% was observed.
- 42% of patients achieved flow-based minimal residual disease (MRD) negativity post-induction.
- 18-month estimates for leukemia-free survival and overall survival were 80% and 95%, respectively.
- The addition of GO was safe, without prolonged cytopenias.
- Subclinical cardiotoxicity was noted in 25% of patients.
Conclusions:
- CPX-351 is a feasible induction therapy for this AML patient population.
- Response and MRD-negativity rates are comparable to standard '7+3' induction.
- Further investigation into CPX-351, potentially with GO, is warranted.
Related Concept Videos
02:50Combination Therapies and Personalized Medicine
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...