RXII incredible breast cancer vaccine results.
DNDN vaccine extended life expectancy for an average 2 months. The Neuvax results seem a lot better to me.
All study groups showed big reductions even though most groups did not have optimal dose.
The Optimal dose group results were eye popping. Recurrance rate dropped from 14.5% to 2.7% for patients that had the vaccine.
Results: The trials have enrolled 188 patients; 109 (58%) HLA-A2/A3+ patients assigned to the vaccination group (VG), and 79 (42%) HLA-A2/A3- patients assigned to the control group (CG). The only significant prognostic difference between the groups was more ER/PR negativity in the VG (p=0.04). With 24 mo f/u complete in all patients, a 24 mo landmark analysis revealed a recurrence rate (RR) of 6.5% in the VG and 14.5% in the CG (p=0.08). At a median f/u of 57 mos, there is a persistent, though not statistically significant, 35% relative risk reduction in recurrences in the VG. Importantly, due to trial design, 72 patients received less then what was determined to be the optimal biologic dose.
In subset 24 mo landmark analyses, patients who benefit most from vaccination were NP (11.5% vs 20.9% RR in VG vs CG, p=0.26), had HER2 IHC 1+, 2+ (7.8% vs 23.5% RR, p=0.06) or grade 1,2 (1.6% vs 16.3% RR, p=0.01) tumors, were optimally dosed (2.7% vs 14.5% RR, p=0.10), and boosted (0% vs 8.5% with early recurrences prior to booster program omitted, p=0.03).
Conclusions: The E75 vaccine may prevent breast cancer recurrence in subsets of patients. To investigate this, a phase III trial with optimal dosing and booster inoculations is being initiated for NP, HER2 IHC 1+,2+ patients.
