The overall DFS for the VG (n=29) was 50% versus 44% for the CG (n=22)(p=0.594).
The final endpoint for the trial was disease free survival (DFS) after two years, or 24 months. The most common systemic toxicities were muscle pain, headache, and fatigue. Systemic toxicities for the 1000mcg group did not show any significant difference as compared to the <1000mcg group.
Following administration of vaccine, local and systemic toxicities were mild at the completion of the series with no grade 4 or 5 toxicities, and only 1 patient experienced grade 3 toxicity, with the most common local toxicities being induration at the injection site, erythema, and pruritus. All patients were disease-free at enrollment. Forty patients were enrolled after standard of care treatment of primary disease and 11 patients after treatment of recurrent disease (5 in the VG, 6 in the CG). The trial began as a dose-escalation Phase 1 trial, transitioning to a Phase 2a comparing expanded dose cohorts with a total of 51 patients enrolled, n=29 in the HLA-A2 positive vaccine group (VG) and n=22 in the HLA-A2 negative control group (CG). George Peoples whose work on our immunotherapy vaccines targeting FBP have set the stage for potential future trials to prevent ovarian cancer recurrence.”
On behalf of the entire Galena team, we would like to thank Dr.
The results of the trial also reiterate our focus on treating patients with primary disease after their initial standard of care treatment where we believe GALE-301 may provide the most benefit. “The data also showed a meaningful correlation between delayed type hypersensitivity reactions and clinical outcomes indicating that the vaccine is able to generate an immune response. “This final data from our early stage clinical trial demonstrates that GALE-301 is well tolerated and we were able to obtain statistically significant disease free survival in a small number of patients treated with the optimal dose,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. The presentation was entitled, “ Analysis of a Phase I/IIa Trial Assessing E39+GM-CSF, a Folate Binding Protein Vaccine, to Prevent Recurrence in Ovarian and Endometrial Cancer Patients.” GALE-301 is a cancer immunotherapy consisting of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in ovarian and endometrial cancer patients in the adjuvant setting. Larry Maxwell at the Annual Meeting on Women’s Cancer 2017 hosted by the Society of Gynecologic Oncology.
The data was given during an oral presentation by Dr. (NASDAQ:GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, today announced the final analysis from the Company’s GALE-301 (E39) investigator-sponsored Phase 1/2a clinical trial. SAN RAMON, Calif., Ma(GLOBE NEWSWIRE) - Galena Biopharma, Inc.