DCprime, the front-runner in the field of relapse vaccines, announced the presentation of updated clinical results for its lead product DCP-001 at the upcoming 61st Annual Meeting and Exposition of the American Society of Hematology (ASH), December 7-10, 2019, Orlando, FL, USA. The long-term follow-up and survival data generated in the Phase 1 clinical trial with DCP-001 in patients with high-risk Acute myeloid leukemia (AML) or Myelodysplastic syndromes (MDS) demonstrate the potential to prolong relapse-free survival (RFS) and overall survival (OS) using an allogeneic, off-the-shelf cell-based vaccine in the post-remission setting. The full abstract is available via the ASH Annual Meeting’s website.
“Our deep dive into the Phase 1 clinical trial results, which we will present in full at the upcoming ASH Annual Meeting, confirms our thinking on when and how our cell-based vaccine DCP-001 can have the greatest impact on patients in the post-remission setting. Treated early and while still in remission, vaccination with DCP-001 can strengthen the immune system’s ability to sustainably control residual disease with one patient surpassing an overall survival of 6 years since inclusion in the trial.”
Erik Manting PhD, CEO of DCprime
“The Phase 1 data have evolved since we last updated the clinical community and provide a strong rationale to further investigate the relapse vaccine approach. With the progress made in the clinical community to implement the assessment of minimal residual disease, or MRD, we have designed the currently active Phase 2 clinical trial for DCP-001 to look even more specifically into DCP-001’s ability to support a long-term immune control of the tumour.”
Jeroen Rovers MD PhD, CMO of DCprime
In the Phase 1 clinical trial, seven out of twelve patients responded to treatment, the other five patients showed progressive disease. These five patients had relapsed or refractory disease at the start of vaccination with detectable circulating peripheral blasts. Moreover, they were vaccinated after induction and consolidation therapy with a median time between diagnosis and first vaccination of 611 days compared to 240 for the responding patients. Of the latter, all were in complete remission (CR) (n=5) or had morphologic marrow blast counts <10% (n=2) at the start of vaccination.
While the median overall survival (OS) for the non-responders was 144 days, the median OS for the responding patients was 1,090 days, with a longest survivor of 2,160 days after vaccination. The median relapse-free survival in those patients who were in CR at vaccination was 420 day, ranging up to 1,849 days in the longest survivor. Patients in the responding group all had intermediate or high-risk disease, based on cytogenetics, indicating their poor prognosis based on the ELN risk classification for AML or the Revised International Prognostic Scoring System (IPSS-R) for MDS. In the responder group, two patients died early in complete remission due to infection at day 90 and 184, respectively. More details on patient characteristics and cytogenetics will be presented by Dr. Luca Janssen and Prof. Dr. Arjan van de Loosdrecht (PI) at ASH.
DCprime’s lead cancer relapse vaccine candidate DCP-001 is generated by transforming a proprietary leukemic cell, DCOne®, into a whole cell-based cancer vaccine. Whereas the parental leukemic cells are poorly immunogenic, DCP-001 is highly immunogenic, making it an attractive cancer vaccine candidate. DCP-001 is currently being evaluated in an international Phase II trial in AML patients in complete remission and with presence of MRD who are ineligible for hematopoietic stem cell transplantations. First results of the (ADVANCE-II) trial are expected to become available in 2020.