Portland, Oregon-based Galena Biopharmaceuticals has begun recruiting breast cancer patients for its Phase III PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial. The trial will test the effectiveness of their vaccine therapy, NeuVax, in preventing recurrence of breast cancer. The target patients have previously achieved remission thanks to standard-of-care therapies but are node-positive (cancer cells have been found in the lymph nodes). The vaccine is ideal for patients who express low to intermediate HER2 levels, a protein that is over-expressed in many forms of cancer. The vaccine trains the body’s immune system to attack cells expressing HER2 that could trigger relapse.
By Nicole May,
There are few options available for women that are low-HER2 and node-positive trying to prevent future breast cancer relapse. According to Mark Ahn, president and CEO of Galena, about 40,000 of the 230,000 women diagnosed each year with breast cancer in the US fit NeuVax’s target patient population. Although treatments exist that target HER2-expressing cells in breast cancer patients (Genentech’s Herceptin), these treatments are mainly for patients expressing high HER2 levels.
The PRESENT trial is currently recruiting patients at its 77 trial sites in North America, Eastern Europe, and the Middle East (thanks to a licensing agreement with Teva). The target enrollment is 700 patients. Each patient will receive four doses of the vaccine therapy once a month for six consecutive months. In addition, booster injections will be given once every six months over the next 30 months. The primary endpoint of the trial is an improvement in disease-free survival (DFS) in the treatment group compared to the control group. Five and ten year DFS and three year overall survival (OS) are secondary endpoints.
The outlook is bright for NeuVax and vaccine immunotherapy treatments in general. According to Dr. Elizabeth Mittendorf, the trial’s principal investigator, Phase II results showed a substantial decrease in recurrence rates: 10% recurrence in vaccinated patients versus 18.3% recurrence in those unvaccinated. In the future, NeuVax may extend beyond breast cancer patients — cancers such as prostate, ovarian, and bladder could take advantage of a HER2-targeting vaccine to prevent tumor growth.