Al's Comment:

 This is data from three vaccine trials for Glioblastoma, and they all show about the same effectiveness: 5 year survival rate of about 33-36%. Historically, the 5 year survival of glioblastoma is about 4%. This is a major improvement. As I mentioned in a few recent articles, I beleive the ultimate cure is going to be a combination of treatments. If we could get 35% survival at 5 years with this vaccine, then maybe add Optune, which alone -if used above 90% of the time - can get another 30%, perhaps these would be complimentary and add up to 65% 5 year survival.  Maybe add in a checkpoint inhibitor, oncolytic virus, Car-T cell, or a targeted therapy or 2, and we could get to a cure! Our patient navigation system is designed to test and track combinations like this - but it will only work once they are approved. Otherwise, it is too hard to do these combinations. Which is why I keep saying we need the promising pathway act! 

Posted on: 11/22/2021

(CTIM-10) Reproducibility of clinical trials using CMV-targeted dendritic cell vaccines in patients with glioblastoma

Friday, November 19, 2021
4:45 PM - 4:50 PM
Room: Ballroom C
Kristen A. Batich, MD, PhD - Duke University Medical Center
INTRODUCTION: Vaccination with dendritic cells (DCs) fares poorly in primary and recurrent glioblastoma (GBM). Moreover, GBM vaccine trials are often underpowered due to limited sample size. METHODS: To address these limitations, we conducted three sequential clinical trials utilizing Cytomegalovirus (CMV)-specific DC vaccines in patients with primary GBM. Autologous DCs were generated and electroporated with mRNA encoding for the CMV protein pp65. Serial vaccination was given throughout adjuvant temozolomide cycles, and 111Indium radiolabeling was implemented to assess migration efficiency of DC vaccines. Patients were followed for median overall survival (mOS) and OS. RESULTS: Our initial study was the phase II ATTAC study (NCT00639639; total n=12) with 6 patients randomized to vaccine site preconditioning with tetanus-diphtheria (Td) toxoid. This led to an expanded cohort trial (ATTAC-GM; NCT00639639) of 11 patients receiving CMV DC vaccines containing granulocyte-macrophage colony-stimulating factor (GM-CSF). Follow-up data from ATTAC and ATTAC-GM revealed 5-year OS rates of 33.3% (mOS 38.3 months; CI95 17.5-undefined) and 36.4% (mOS 37.7 months; CI95 18.2-109.1), respectively. ATTAC additionally revealed a significant increase in DC migration to draining lymph nodes following Td preconditioning (P=0.049). Increased DC migration was associated with OS (Cox proportional hazards model, HR=0.820, P=0.023). Td-mediated increased migration has been recapitulated in our larger confirmatory trial ELEVATE (NCT02366728) of 43 patients randomized to preconditioning (Wilcoxon rank sum, Td n=24, unpulsed DC n=19; 24h, P=0.031 and 48h, P=0.0195). In ELEVATE, median follow-up of 42.2 months revealed significantly longer OS in patients randomized to Td (P=0.026). The 3-year OS for Td-treated patients in ELEVATE was 34% (CI95 19-63%) compared to 6% given unpulsed DCs (CI95 1-42%). CONCLUSION: We report reproducibility of our findings across three sequential clinical trials using CMV pp65 DCs. Despite their small numbers, these successive trials demonstrate consistent survival outcomes, thus supporting the efficacy of CMV DC vaccine therapy in GBM.


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