Mendus has presented survival data based on the completed active study period and long-term follow-up to date from the ADVANCE II clinical trial at the American Society of Hematology Annual Meeting.

ADVANCE II is a Phase 2 monotherapy trial evaluating DCP-001 as a maintenance therapy in acute myeloid leukemia (AML) for patients brought into complete remission through chemotherapy, but with measurable residual disease (MRD). The ADVANCE II trial has completed the 70-week follow-up period after start of DCP-001 treatment, and patients are now in long-term follow up. Median follow-up for the entire study population at the data cut-off for ASH on 22nd of November was 19.4 months. Median relapse-free survival (RFS) was not yet reached, with 12 out of 20 patients still in complete remission, ranging from 16 to 47 months after start of treatment. Median overall survival (OS) currently stands at 30.9 months.

“The survival data from the ADVANCE II trial show the potential of DCP-001 to bring a meaningful improvement as compared to current standard of care, particularly for patients with measurable residual disease,” said Dr. Arjan van de Loosdrecht, Principal Investigator of the ADVANCE II trial “Considering the limited options currently available for AML maintenance therapy, new treatments are clearly needed, and novel therapies designed to activate the patient’s immune system such as DCP-001 could become an important approach.”

“We could not be more pleased with the data from the ADVANCE II trial studying DCP-001 in a very challenging patient population, with MRD being associated with fast relapse in AML.”

Increased immune responses against tumor-associated antigens were seen in 17 out of 20 patients following DCP-001 administration, with a significantly higher number of immune responses observed in patients with an MRD response. As reported earlier, treatment with DCP-001 resulted in an MRD response in 7 out of 20 evaluable patients, with 5 patients converting to MRD negativity and 2 patients with a decline in MRD of at least 10-fold. Patients converting to MRD negativity following DCP-001 treatment continue to have a significantly better overall survival, with all still being alive to date.

“Residual disease and tumor recurrence is what causes most cancer-related deaths. We could not be more pleased with the data from the ADVANCE II trial studying DCP-001 in a very challenging patient population, with MRD being associated with fast relapse in AML,” said Erik Manting, PhD, Chief Executive Officer of Mendus. “The survival data reported at ASH, combined with the immunomonitoring results and earlier reported MRD data, confirm that DCP-001 could have a large therapeutic potential as a maintenance therapy in AML and possibly in additional indications where residual disease poses a threat to patients.”

“This provides the basis for further studies in AML patients with residual disease, either after initial treatment with high-dose chemotherapy or other regimens, or following hematopoietic stem cell transplantation.”

Longer-term follow up confirms the excellent safety profile of DCP-001, with no drug-related serious adverse events reported and injection-site reactions as the most common drug-related adverse events.

“These results from the ADVANCE II trial provide clinical proof of concept of DCP-001 as an effective maintenance treatment for patients with AML, reducing residual disease and prolonging disease-free and overall survival,” said Jeroen Rovers,  CMO of Mendus. “This provides the basis for further studies in AML patients with residual disease, either after initial treatment with high-dose chemotherapy or other regimens, or following hematopoietic stem cell transplantation.”

Photo of Erik Manting: Mendus