Immunicum has announced updated interim results from the ongoing ADVANCE II clinical trial evaluating the company’s lead development program DCP-001, a novel therapeutic option for acute myeloid leukemia (AML) maintenance therapy in patients with measurable residual disease (MRD).
The analysis demonstrates the therapeutic potential of DCP-001 to control MRD based on the complete read-out of all 20 evaluable patients. In addition, the interim survival data provides for a first strong indication on how the effects of DCP-001 vaccination observed on MRD translate into relapse-free and overall survival benefits for this patient population, states the company. The previously reported clean safety and tolerability profile of DCP-001 was confirmed.
“With only one sole drug specifically approved for post-remission AML maintenance treatment, AML patients in remission have historically been underserved with respect to solutions prohibiting or at least delaying cancer recurrence. The achievement of MRD conversions after DCP-001 treatment, coupled with a compelling safety profile, is an exciting step forward for Immunicum and the AML patient population with continued unmet need,” commented Jeroen Rovers, Chief Medical Officer of Immunicum. “The ADVANCE II data contribute to the growing body of evidence that reducing MRD directly correlates with a relapse-free and overall survival benefit for patients. We are confident that the outcome of the ADVANCE II study will provide a strong rationale for continued evaluation of DCP-001 in a larger clinical trial.”
The international, multi center, open-label Phase II study ADVANCE II enrolled AML patients in complete remission (CR) following chemotherapy induction, but who remained MRD positive and were therefore deemed to be at elevated risk of relapse. Patients in the ADVANCE II trial were divided into two cohorts of 10 patients each, administered with two different dose levels of DCP-001, 25 and 50 million cells/vaccination. Patients in each cohort received four biweekly doses of DCP-001, followed by additional booster administrations at weeks 14 and 18. MRD responses were recorded at 14, 20, and 32 weeks and patients were followed for up to 70 weeks after first administration. Median follow up of patients at the cut-off date for the interim analysis was 14.3 months. The primary endpoint of the study is MRD response, and the secondary endpoints of relapse free survival (RFS) and overall survival (OS).
At the cut-off date for the interim analysis, 7 patients out of twenty showed a MRD response, with 5 patients converting from MRD+ to MRD-, and 2 patients achieving a substantial, at least 10-fold reduction in MRD throughout the course of the trial. Patients who converted from MRD+ to MRD- over the course of the trial demonstrated an improved survival over those not having fully converted. An additional seven patients remained in complete remission (CR) with stable MRD levels and only six patients encountered relapse. Intradermal injections of DCP-001 were well tolerated, with only limited drug related side effects. No serious adverse events were reported in conjunction with DCP-001.
To date, with a median follow-up on study of 14.3 months, the median RFS and OS have not yet been reached. The estimated 6-month RFS based on the data available to-date is 83.7%, with an estimated 6-month OS of 97.0%.
The trial is continuing follow-up of patients to assess RFS and OS and Immunicum expects to report on the status of these endpoints and immuno-monitoring data in Q4 2022.
Photo of Jeroen Rovers, Chief Medical Officer of Immunicum