A new murine monoclonal antibody B43.12 is under investigation in combination with paclitaxel and carboplatin as a treatment option for patients with advanced epithelial ovarian cancer.
Oregovomab (Ovarex) in combination with paclitaxel and carboplatin for patients with advanced epithelial ovarian cancer is being tested in the phase 3 FLORA-5 trial (NCT04498117). Oregovomab is an investigational monoclonal antibody with promising phase 2 data. Oregovomab and the FLORA-5 trial were highlighted during the 2022 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in March.
“Oregovomab is an investigational monoclonal antibody that has been studied in clinical trials for patients with ovarian cancer whose tumor cells express the tumor-associated antigen CA-125 (MUC16),” the investigators noted in a poster presentation during the meeting. “Oregovomab is a novel immunotherapy that enhances the immune response to CA-125.”
The phase 3 double-blind, placebo-controlled, multicenter study has been designed to compare the safety and efficacy of oregovomab plus chemotherapy with placebo plus chemotherapy. Patients will be randomly assigned 1:1 to receive either 2 mg of intravenous oregovomab or placebo, along with 6 standard cycles of paclitaxel/carboplatin.
Additionally, investigators will seek to confirm the clinical benefit observed in a randomized phase 2 study (NCT01616303), which demonstrated that adding oregovomab to paclitaxel and carboplatin resulted in clinically significant improvements in progression-free survival (PFS) and overall survival (OS).
Investigators noted that the trial will also seek to evaluate the role of oregovomab as a neoadjuvant chemotherapy option.