Most breast cancer survivors carry the fear of a recurrence. So, I am glad to have the opportunity to share this post by Mark Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma.
Preventing Breast Cancer Recurrence: The First Novel Cancer Immunotherapy in Late-Stage Clinical Trials
An innovative approach is the development of cancer immunotherapies which activate the patients’ own immune system to target tumor cells in a highly specific, less toxic and more convenient approach compared to conventional cancer therapies.
Biopharmaceutical company Galena Biopharma www.galenabiopharma.com is developing an immunotherapy vaccine called NeuVaxT (nelipepimut-S) for early stage, lymph node-positive, breast cancer patients with HER2 IHC 1+/2+ (or low to intermediate HER2 protein expression) to delay or prevent disease recurrence. NeuVax uses the body’s own immune system to activate cytotoxic T-cells – the immune cells that protect the body by searching out and destroying cells that display a specific marker not found on healthy cells.
NeuVax is conveniently given as an intradermal injection once a month for six months, followed by a booster injection once every six months. About 75 percent of breast cancer patients test positive for HER2 (human epidermal growth factor receptor 2). HerceptinR (trastuzumab; Genentech/Roche) targets HER2 breast cancer cells, but is only approved by the U.S. Food and Drug Administration for HER2 positive (IHC 3+) patients which targets 20-30 percent of the more than 230,000 women in the U.S. diagnosed with breast cancer annually.
It’s known that in node positive breast cancer patients, approximately 25 percent will relapse within 3 years. Currently there are no available therapies for the 50-60 percent of women with HER2 IHC 1+/2+ breast cancer after their initial adjuvant treatment, except for hormone therapy where appropriate. These women are simply sent home to ‘watch and wait’ and are observed closely for the next 5 years to determine signs of cancer recurrence.
NeuVax targets these HER2 IHC 1+/2+ breast cancer patients who are not eligible to receive other therapies after their initial treatment. This is the patient population being enrolled in the Phase 3 PRESENT trial (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) using Galena Biopharma’s NeuVax cancer vaccine. www.clinicaltrials.gov/ct2/show/NCT01479244?term=e75 <http://www.clinicaltrials.gov/ct2/show/NCT01479244?term=e75&rank=3> &rank=3.
The basis for the PRESENT trial comes from promising data presented at the 2012 San Antonio Breast Cancer Symposium (SABCS). At SABCS, Galena Biopharma presented the final 60-month Landmark Analysis from its Phase 1/2 studies of NeuVax.
Principal Investigator Elizabeth Mittendorf, M.D., Ph.D., Assistant Professor of Surgical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, presented data showing a 5.6 percent recurrence rate with NeuVax versus a 25.9 percent recurrence rate in the control arm, for those patients who received booster inoculations.
Enrollment for the 700 patient PRESENT trial is ongoing at over 100 clinical sites open throughout the U.S., Canada, Western and Eastern Europe, and Israel.
The PRESENT trial, conducted under an FDA-approved Special Protocol Assessment (SPA), will measure disease-free survival at three years, defined as the recurrence of cancer and will include a 70 patient interim data analysis. Further, based on an earlier trial showing synergy in combination use, a Phase 2B trial is now enrolling 300 patients to test the effectiveness of combining NeuVax and Herceptin to prevent cancer recurrence in HER2 negative patients.
In addition to developing the NeuVax breast cancer vaccine, Galena Biopharma recently acquired AbstralR (fentanyl) Sublingual Tablets for commercialization in the United States for the management of breakthrough cancer pain in opioid tolerant patients. Abstral delivers fast-acting relief and rapid blood stream absorption for breakthrough cancer pain and was approved by the FDA in 2011. It is the transmucosal immediate-release fentanyl (TIRF) product market leader in Europe. Galena expects to launch Abstral in the U.S. by the end of the year.
Breakthrough cancer pain occurs in 40-80 percent of patients who are already receiving chronic, long-acting opioid pain management. These severe flare-up episodes of background pain resulting from cancer disease, treatment or both may occur four or more times per day lasting 30-60 minutes and impairing patients’ quality of life.
For more information about enrolling in the NeuVax breast cancer vaccine trial and convenient clinical site locations, visit the website (www.neuvax.com).
Mark J. Ahn, Ph.D. is President & Chief Executive Officer of Galena Biopharma (Nasdaq: GALE) http://twitter.com/NeuVax http://www.facebook.com/NeuVax Elizabeth Mittendorf, M.D., Ph.D., Assistant Professor of Surgical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, focuses both her clinical and laboratory efforts on the study of breast cancer with a specific interest in breast cancer immunotherapy. http://www.mdanderson.org/
