Researchers are continually investigating ways to help patients with AML. Clinical trials provide great insight and a controlled environment to do so with prolonged survival always being the goal.
Interim results on phase 2 study, ADVANCE II have recently been released. This trial was designed to show that DCP-001 is a new and effective vaccine as a maintenance therapy in AML patients with MRD (Measurable Residual Disease). This study is being conducted by the biopharmaceutical company, Immunicum.
- 20 patients were selected based on MRD positive status.
- Bi-weekly cell injections (25 to 50 million cells) were done on weeks 0, 2, 4, 6.
- 2 booster injections (10 million cells) were given on weeks 14 and 18.
- This trial analysis demonstrates the potential for DCP-001 to control MRD.
- The median age of patients was 60 years old (half were female).
- No serious reactions occurred and the drug was well received.
“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.”
DCP-001 is becoming a cell based cancer vaccine. It can transform a leukemia cell. This transformation leads to an immunogenic shift. “Following the immunogenic shift, DCP-001 induced the production of a broad range of pro-inflammatory cytokines, was able to suppress tumor growth in animal models and was efficiently recognized by human immune cells as compared to leukemic cells.”
The current results of this trial provide hope that DCP-001 will become a regular, therapeutic treatment for AML and provide a significant survival benefit. Analysis of the primary trial was completed with 7 patients showing a MRD response, of which 5 patients converted from MRD positive to MRD negative and 2 patients showed a substantial, at least 10-fold reduction in MRD following treatment with DCP-001.
“Investigators evaluated MRD responses after the 4 initial vaccinations with a median time on study less than 14.3 weeks. MRD responses were durable in 4 of 5 patients who remained MRD-negative to week 32. The median time between the initiation of DCP-001 therapy and chemotherapy for the whole patient population was 295 days. MRD responses showed a link to prolonged survival. Both median relapse free survival and median overall survival were not reached. The estimated probability of relapse free survival at 6 months is 83.7%, and the estimated probability of overall survival at 6 months is 97.0%. Investigators noted that converted MRD patients stayed relapse-free at follow up.”
“With the majority of patients still relapse-free at the moment of this read-out, this update provides for a first clear signal that MRD responses following DCP-001 vaccination translate into relevant survival benefit,” commented Erik Manting, PhD, Chief Executive Officer of Immunicum.”
Immunicum plans to present further details and trial results on survival data (including relapse free survival and overall survival) in Quarter 4 of 2022.
about the author
Lisa Foster is a mom of 3 daughters, a puzzle lover, writer and HealthTree advocate. She believes in the mission of the foundation and the team that builds it forward. She calls Houston, Texas home.