Martinsried -
The study was conducted at the
The trial's primary outcome measures assessing 1) the feasibility of DC vaccine manufacturing/administration, and 2) its safety/tolerability over 2 years, were successfully achieved. The DC vaccinations were well tolerated with no serious adverse events (SAEs) related to the treatment.
The secondary outcome measures evaluating key clinical parameters show that after 24 months of treatment overall survival rate (OS) was 80% (16 of 20 patients, 95% confidence interval (CI): 55 to 92%) and progression free survival rate (PFS) was 55% (11 of 20 patients, 95% CI: 31 to 74%).
In the current AML treatment paradigm, patients 60 years of age or older are often ineligible for hematopoietic stem cell transplantation and have poorer treatment outcomes. This group accounted for 50% of patients in this trial (risk groups good, intermediate, poor: 4, 4, 2) and an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 50% (5 of 10 patients, 95% CI: 18 to 75%) was observed at 24 months. In the patient group younger than 60 years of age (risk groups good, intermediate, poor: 9, 1, 0), also an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 60% (6 of 10 patients, 95% CI: 25 to 83%) was observed at 24 months.
As disclosed at the time of the 12-months interim analysis in
Dr.
The now final topline results from this Phase I/II clinical trial with patient-derived DCs confirm the previously published promising 12-months interim analysis. The clinical outcome is encouraging, not only regarding the excellent safety and tolerability profile, but also for an overall survival when it comes to secondary endpoints.'
Prof.
About
In addition to
Dendritic cells (DC) are a specialized type of immune cells. They patrol throughout our body, take up antigens, process them and present short peptides on their cell surface. These peptides are recognized by other types of immune cells such as T cells or natural killer (NK) cells, which then become activated. In this way, the activated immune cells are enabled to recognize and eliminate tumor cells.
The scientific team of
About acute myeloid leukemia (AML)
Acute myeloid leukemia (AML) is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age.
AML is a heterogeneous type of cancer affecting patients' blood and bone marrow. It is characterized by an overproduction of myeloid progenitor cells named myeloblasts or leukemic blasts. These cells prevent the generation of normal blood cells, causing a decrease in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and bleeding. AML progresses rapidly and may be fatal within a few weeks or months, if untreated.
AML is typically treated initially with intensive induction chemotherapy in order to achieve remission. Some patients are eligible to receive additional chemotherapy or an allogeneic hematopoietic stem cell transplant (HSCT), which increases the potential for eradication of residual tumor cells. However, HSCT induces high morbidity and mortality and only less than half of the AML patients can be treated with HSCT.
Additionally, elderly patients may be unable to complete the full regimen of intensive chemotherapy due to its high toxic side effects. Thus, the majority of elderly patients remain undertreated and continue to experience minimal residual disease (MRD) burden that sooner or later will lead to leukemia relapse.
About the DC study design
The DC study (NCT02405338) was designed as an open-label trial at
Patients participating in the trial had AML that was positive for Wilms Tumor-1 (WT-1) antigen with or without positivity for Preferentially Expressed Antigen in Melanoma (PRAME). Patients were vaccinated with their WT-1/PRAME DC vaccines monthly over a 24-month period (with a higher frequency within the first 6 weeks). AML diagnoses had been established with a median of 9.8 months before the first vaccination (range 4.5 to 17.5 months), and the last chemotherapy infusion had been performed at a median of 6.9 months (range 2 to 14.8 months).
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