2019 ASCO-SITC Symposium: IL-12 Plasmid Plus Neoadjuvant Chemotherapy in Ovarian Cancer
Posted: Wednesday, March 6, 2019
The addition of GEN-1, an interleukin-12 (IL-12) plasmid formulated with polyethyleneglycol-polyethyleneimine-cholesterol lipopolymer, to taxane and carboplatinum appeared to be safe and active among patients with epithelial ovarian cancer receiving neoadjuvant therapy, according to a study presented at the 2019 American Society of Clinical Oncology–Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium in San Francisco (Abstract 2). Premal H. Thaker, MD, MS, of Washington University at St. Louis, and colleagues noted that although dose-limiting toxicity was not reached in this study, dose-escalation and safety profiles are being evaluated in an ongoing phase I/II study.
The study authors enrolled 18 patients with newly diagnosed epithelial ovarian cancer who had never received prior therapies. Of them, 12 received all 8 treatments with no dose-limiting toxicities, and 14 patients underwent interval debulking surgery.
GEN-1 appeared to be active and well tolerated among patients receiving neoadjuvant therapy. Prior to interval debulking surgery, the authors observed complete responses among 2 patients, partial responses in 10 patients, and stable disease in 2 patients. Of the 14 patients who underwent interval debulking surgery, residual disease was reported as R0 in 9 patients, R1 in 3 patients, and R2 in 2 patients. Pathologic response after interval debulking surgery was classified as complete pathologic response (n = 1), macroscopic (n = 7), and microscopic (n = 6).
The most common treatment-related toxicities were grade 1 nausea, abdominal pain, and fatigue. A single patient presented with grade 2 fevers associated with GEN-1 treatment but responded to acetaminophen and fluids.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.