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news.Apthera has announced encouraging results from the analysis of a randomized safety and efficacy clinical trial studying NeuVax in the adjuvant treatment of early-stage HER2-positive breast cancer. The data showed that patients with low-expressing HER2 tumors experienced decreased breast cancer recurrence and no mortality to-date following treatment.
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In the NeuVax (E75) trial 163 patients with breast cancer were enrolled to determine whether the level of HER2 (human epidermal growth factor receptor 2) expression affected response. Of the patients assessed, 92 underwent treatment. Within the treatment group, 56 (66%) were defined as HER2 low-expressors. The control group included 44 (67%) low-expressors.
Low HER2 expressing patients maintained circulating, E75 peptide reactive T-cells after one year whereas patients with HER2 over-expressing tumors returned to pre-immunization levels. At a median follow-up of 30 months, disease recurrence was substantially reduced for treated patients with low HER2 expression. Low-expressors by Immunohistochemistry or IHC in the treatment arm of the study experienced 8% recurrence, compared with 21% for patients in the control arm.
Alton Charles Morgan, president and CEO of Apthera, said: “These results are encouraging for HER2 low-expressing breast cancer patients who have few treatment options in the adjuvant setting and are not typically eligible for Herceptin therapy.”