Oslo University Hospital Rikshospitalet was the site of an experimental autologous dendritic cell (DC) vaccine that was tested in an open-label, Phase I/II clinical trial in Acute Myeloid Leukemia (AML) patients. With the primary outcomes announced by Munich-based Medigene AG, the German sponsor announced the measures assessing the feasibility of DC vaccine manufacturing/administration and its safety/tolerability over two years was successfully achieved. Moreover, the secondary outcome measure results reveal that after 24 months of treatment, overall survival rate (OS) was 80% (16 of 20 patients), and progression-free survival rate (PFS) was 55% (11 of 20 patients).

The Study

Conducted at Oslo University Hospital, Rikshospitalet conducted this Phase I/II clinical trial, open-label, prospective, non-randomized study in 20 patients, including a safety-run in Phase I part comprising of 6 patients.

The Discussion

The sponsor reports in recent news, that the results were indeed very positive—in addition to the survival data, the sponsor was successfully able to manufacture the DC vaccine from chemotherapy pretreated AML patients.

The trial’s primary outcome measures assessing 1) the feasibility of DC vaccine manufacturing/administration, and 2) its safety/tolerability over two 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%, and progression-free survival rate 55%.

Current AML Treatment Paradigm

In the current treatment paradigm, those patients 60 and up are 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 out of 10 patients, 95% Cl, 41 to 95%) and a PFS of 50% (5 of 10 patients, 95% Cl: 18 to 75%) was observed at 24 months. In the patient group under 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% Cl: 25 to 83%) was observed at 24 months.

Company CEO Point of View

Professor Dolores Schendel, CEO, and CSO of Medigene AG, reported, “We are pleased with these positive and promising results from the first clinical trial of DC vaccine. We thank all the patients for participating in the trial and the study team for their efforts and contributions. In the future, this novel clinical approach could offer a treatment possibility for AML patients who have insufficient treatment options and face the risk of relapse. We are looking forward to providing further updates. More detailed data and analyses will be presented at upcoming scientific conferences.”

Clinical Investigator Comment

Dr. Yngvar Floisand, Head Physician of the Department of Hematology at the Oslo University Hospital and Principal Investigator of the trial, comments: “New treatment options are desperately needed for patients with AML. The disease progresses rapidly and may be fatal within a few weeks or months, if untreated. Even despite having received a treatment, the majority of predominantly elderly patients continue to experience minimal residual disease burden that sooner or later leads to relapse of the disease. Medigene’s DC vaccine trial was designed towards potentially making new treatments available for these patients, specifically aiming at reducing the risk of relapse in treated patients after completing conventional chemotherapy.

Lead Research/Investigator

Dr. Yngvar Floisand 

Source: Medigene

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