The findings were unveiled in a presentation entitled “Phase 1 Trial Results of a Folate Receptor Alpha-directed Cancer Vaccine (E39) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence”, at the Society for Immunotherapy of Cancer Conference 2013 on November 7-10, 2013. The conference took place in National Harbor, Maryland.
“New approaches are needed for ovarian and endometrial cancer patients who face a high risk of disease recurrence. The initial results from the Phase 1 trial show that the FBP vaccine may be a potential cancer immunotherapy treatment to prevent recurrence in these high risk patient populations,” concluded Dr. Erika J. Schneble, San Antonio Military Medical Center, San Antonio, TX, who presented the results at the SITC conference.
The purpose of the trial was to determine the therapy’s safety, initial efficacy indicators, optimal dosage, and immunological response. Researchers found the optimal dose was 500 mcg peptide combined with 250 mcg GM-CSF. Only Grade 1 toxicities were found, mostly consisting of injection site reactions, indicating strong patient tolerance. After a median follow-up of six months, two (2) reoccurrences had taken place (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group. However, the trial was not equipped for any efficacy measurements.
FBP is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial, and ovarian cancer patients rendered disease-free after completing standard of care therapy. It is a well-established therapeutical target for breast, ovarian, and endometrial cancers. Over 22,000 patients per year in the U.S. have ovarian cancer, and it is the most lethal gynecologic cancer. Despite ovarian cancer incidence being only around 20% of that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% of that of breast cancer.
Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the U.S. annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course, and the majority of these patients will die of this form of the disease.
“We are encouraged by the initial results of our Phase 1 trial with the FBP vaccine, showing that it is well-tolerated and demonstrated promising immune responses in high risk gynecological cancers,” said Mark J. Ahn, President and Chief Executive Officer of GALE. “As a result, we are moving forward with the Phase 2a component which will be initiated by year end and will include the enrollment of additional patients at the optimal dose as well implementing a booster regimen.”
For more information about GALE and the details of the study itself, visit: www.galenabiopharma.com
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