Additional Information
Clinical Data
Update on Mar 17 2017: The final endpoint for the trial was disease free survival (DFS) after two years, or 24 months. The overall DFS for the VG (n=29) was 50% versus 44% for the CG (n=22)(p=0.594). Importantly, the two-year DFS was significantly higher in the optimally dosed 1000mcg group (n=15) with 77% DFS versus 44% DFS in the CG (n=22) patients (p=0.05). Patients with primary disease who received the 1000mcg dose appear to maintain a statistically significant benefit while those with recurrent disease were not. Given the small number of patients in the recurrence group, this finding needs to be confirmed in a larger trial. In the trial, those patients with a lower expression of FBP performed better with an 86% DFS in the VG (n=8) versus 18% in the CG (n=11), p=0.01. This reiterated our prior analysis that high levels of FBP expression associated with more aggressive disease may outpace the immune response and diminish the therapeutic effects of the vaccine. The correlation between delayed type hypersensitivity (DTH) reactions and clinical outcome was also analyzed. DTH was significantly increased from pre- to post-vaccination in the group receiving the optimal dose of 1000 mcg (p=0.03).The trial was conducted as a prospective Phase 1/2a trial of E39+GM-CSF to prevent recurrence in disease-free ovarian and endometrial cancer patients at high risk for recurrence after standard of care treatments. Eligible patients included patients with primary or recurrent endometrial, ovarian, fallopian tube, or peritoneal cancer. Once enrolled, HLA-A2 positive patients were inoculated with E39+GM-CSF and HLA-A2 negative patients were followed prospectively as matched controls. The primary vaccination series consisted of six total vaccinations, one given every 21-28 days, and the dose escalation scheme consisted of dosing cohorts of 3 patients each receiving one of the following doses: 100μg, 500μg, and 1000μg in addition to 250μg GM-CSF. Two booster inoculations were given, one every six months. In vivo immune monitoring was assessed using DTH measured pre- and post-vaccination. Patients were monitored for evidence of clinical recurrence every 3 months and the pre-specified intention-to-treat analysis was performed at 12 and 24 months after the last patient was enrolled.
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