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The abstract on ICT-107 was released last night and is just a brief summary of the trial results as they were reported in December, 2014; there is no information in the abstract that was not previously known. However, there will be an oral presentation at the Central Nervous System Tumors session on Sunday, June 1st at 10:00-10:12 AM CST. This will update data from the results presented in December and could result in important new information. IMUC is preparing to move ICT-107 forward in a phase 3 trial.

The results reported in December showed a statistically significant improvement in the secondary endpoint of progression free survival of 2 months. The primary endpoint of median overall survival did not reach statistical significance because of the small size of the trial but showed a numerical improvement of 2 months. For reference, the Stupp trial which led to the approval of temozolomide as part of standard of care for newly diagnosed glioblastoma multiforme showed that temozolomide improved median overall survival by 2.5 months.

I think that there is the potential for meaningful new data to be presented at the ASCO oral presentation on immunological results from the trial. Also, there have been 12 deaths since December resulting in a total of 69, up from 57. In December, the median death had not occurred in either the ICT-107 group or the control group. Hence, we could see an improvement in the length of median overall survival and progression free survival. I wrote a more extensive report on what to look for at ASCO in my recent May 14 report: ImmunoCellular Has Plans to Move ICT-107 Forward into Phase 3 Trials; Should It? (IMUC, $1.19 Trading Buy, For Paid Subscribers).

The Abstract Reproduced

The complete abstract is shown below.

Background: The trial investigated whether adding tumor-antigen-loaded DC vaccine to surgery and chemoradiation would improve overall survival (OS) or progression free survival (PFS).

Methods: HLA-A1+ and/or -A2+ resected patients with residual tumor <1 cm³Â received 6 weeks of concurrent temozolomide (TMZ) and radiation. 124 patients were randomized 2:1 to receive ICT-107 (autologous PBMC-derived DC pulsed with 6 synthetic peptide CTL epitopes targeting the GBM tumor and tumor stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL-13Rα2) or its matching control (unpulsed DC). Patients then received induction ICT-107 or control QWx4 followed by maintenance TMZ, 5 days/mo for 12 mos. Booster vaccinations occurred at 1, 3, and 6 mos after induction, and every 6 mos thereafter. The trial concluded and data were evaluated at 67 events.

Results: ICT-107 was generally safe and well tolerated, with no imbalance in AEs between the treated and control groups. PFS improved by 2 mos in the ICT-107 ITT group (p=0.02 two-sided, hazard ratio (HR)=0.56). In the per-protocol (PP) group (117 patients receiving all 4 induction vaccinations), p=0.01 two-sided, HR=0.53, and the difference in median PFS increased to 3 mos. The median OS favored ICT-107 by 2 mos in the ITT and 3 mos in the PP groups. However, the number of events was small and OS did not reach statistical significance (p=0.58 two-sided, HR=0.87, and p=0.40 two-sided, HR=0.79, respectively). Median follow-up from randomization was 13.6 mos. In the ICT-107 group, vaccine activation markers IL12 and HLA-DR were predictive of OS (p-values < 0.05). There were no correlations in the placebo group.

Conclusions: This is the first randomized, placebo-controlled immunotherapy trial in GBM to positively affect a clinical outcome, PFS. Although OS improvement was not statistically significant at the 67/124 event point, patients continue to be followed for OS, allowing periodic updating of the primary endpoint and assessment of long-term survival. Analysis of QOL, and correlation of both tumor antigen expression and vaccine immunologic response with OS are in process.