Galena Biopharma (GALE) Updates on NeuVax w/ Herceptin Phase 2 Design
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Galena Biopharma (Nasdaq: GALE), presented the trial design for the upcoming Phase 2 combination trial with NeuVax (E75 plus GM-CSF) and Herceptin (trastuzumab; Genentech/Roche) at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium. The event is being held December 6-10, 2011 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
The previously reported pilot Phase 2 trial investigated sequential therapy with trastuzumab followed by HER2 vaccination in the adjuvant setting. Of 62 patients who received standard-of-care trastuzumab, the 32 who received no vaccine experienced a 12.5% breast cancer recurrence rate (4/32), comparable with reported rates of similarly staged and treated patients. In contrast, of the 30 patients who were vaccinated with vaccine following trastuzumab therapy, the recurrence rate was 0% (0/30) (p=0.065). The median follow-up for this cohort is 48 months.
Based on this data, it is hypothesized that combination adjuvant immunotherapy with NeuVax and trastuzumab will result in a greater reduction in breast cancer recurrence than trastuzumab therapy alone. The multi-center, prospective, randomized, single-blinded Phase 2 trial will evaluate the efficacy of this immunotherapy combination in breast cancer patients with HER2 low- and intermediate-expressing tumors (HER2 1+, 2+) in the adjuvant setting. Disease-free patients at risk for recurrence will be randomized to receive trastuzumab + NeuVax versus trastuzumab + GM-CSF alone. The primary endpoint will compare disease-free survival at 24 months between the treatment arms. Secondary endpoints include disease-free survival at 36 months, immunologic responses to vaccination, and safety.
The previously reported pilot Phase 2 trial investigated sequential therapy with trastuzumab followed by HER2 vaccination in the adjuvant setting. Of 62 patients who received standard-of-care trastuzumab, the 32 who received no vaccine experienced a 12.5% breast cancer recurrence rate (4/32), comparable with reported rates of similarly staged and treated patients. In contrast, of the 30 patients who were vaccinated with vaccine following trastuzumab therapy, the recurrence rate was 0% (0/30) (p=0.065). The median follow-up for this cohort is 48 months.
Based on this data, it is hypothesized that combination adjuvant immunotherapy with NeuVax and trastuzumab will result in a greater reduction in breast cancer recurrence than trastuzumab therapy alone. The multi-center, prospective, randomized, single-blinded Phase 2 trial will evaluate the efficacy of this immunotherapy combination in breast cancer patients with HER2 low- and intermediate-expressing tumors (HER2 1+, 2+) in the adjuvant setting. Disease-free patients at risk for recurrence will be randomized to receive trastuzumab + NeuVax versus trastuzumab + GM-CSF alone. The primary endpoint will compare disease-free survival at 24 months between the treatment arms. Secondary endpoints include disease-free survival at 36 months, immunologic responses to vaccination, and safety.
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