https://orcid.org/0000-0003-4094-2097
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Abstract
A consensus regarding subsequent therapeutic strategies for patients with platinum- and poly (ADP-ribose) polymerase inhibitor (PARPi)-resistant ovarian cancer is lacking. These patients typically receive non-platinum-based chemotherapy; however, survival outcomes remain poor. Compared with chemotherapy alone, combination therapy with novel target agents can provide additional benefits to these patients. Oregovomab, an investigational murine monoclonal antibody against CA-125, has shown promising efficacy in a phase II study in patients with recurrent ovarian cancer. Herein, we described the rationale and design of OPERA/KGOG 3065/APGOT-OV6, a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi/platinum-resistant ovarian cancer. The primary end point was the objective response rate, according to RECIST 1.1.
Clinical Trial Registration: NCT05407584 (ClinicalTrials.gov)
Plain language summary
OPERA/KGOG 3065/APGOT-OV6 is a promising phase II studies that test new drug (oregovomab) on the patients with poly (ADP-ribose) polymerase inhibitor (PARPi)/platinum-resistant epithelial ovarian cancer. PARPis have changed the treatment landscape of ovarian cancer in a relatively short time. PARPi/platinum-resistant epithelial ovarian cancer refer to a subtype of recurrent epithelial cancer of ovarian, tubal or peritoneal origin who experienced disease progression despite treatment with a PARPi or platinum-based chemotherapy drugs. Although various new drugs have been tested to improve the treatment response in resistant patients, a consensus regarding the international standard of treatment is yet to be established, despite the poor survival outcomes of these patients. OPERA/KGOG 3065/APGOT-OV6 has been designed to add oregovomab, a murine monoclonal antibody to cancer antigen-125 (CA-125), to non-platinum chemotherapy (pegylated liposomal doxorubicin or paclitaxel) for patients with ovarian cancer determined as PARPi/platinum-resistant and ineligible for bevacizumab treatment. The results of this study will aid in developing effective treatment strategies for patients with PARPi/platinum-resistant ovarian cancer.
TWEETABLE ABSTRACT
OPERA/KGOG 3065/APGOT-OV6: a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with poly (ADP-ribose) polymerase inhibitor/platinum-resistant ovarian cancer.
Subsequent therapeutic strategies for patients with platinum- and poly (ADP-ribose) polymerase inhibitor (PARPi)-resistant ovarian cancer are to be established.
Oregovomab, a murine monoclonal antibody specifically targeting cancer antigen (CA)-125, has shown promising efficacy in patients with recurrent ovarian cancer, achieving a median progression-free interval of 11 weeks and median overall survival of 70.4 weeks.
The efficacy of oregovomab in combination with non-platinum chemotherapy for patients with PARPi/platinum-resistant epithelial ovarian cancer (EOC) remains unexplored.
The OPERA/KGOG 3065/APGOT-OV6 is designed to investigate the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi-resistant EOC unsuitable for platinum-based therapy.
The findings of this trial will afford novel insights into the antitumor efficacy and safety profile of oregovomab plus non-platinum chemotherapy in patients with PARPi-resistant EOC.
Acknowledgments
The authors would like to thank the patients and their families, as well as the investigators, for their kind assistance with this research
Author contributions
J-Y Lee is the principal investigator. The study was designed by J-Y Lee. J-Y Lee and J Park acquired the funding. HW Cho, MC Lim, CH Choi and J-Y Lee recruited study participants and aided in data collection. J Park wrote original draft. All other authors contributed to the writing and review of the manuscript. The corresponding author had final responsibility for the decision to submit for publication on behalf of the collaborative authors’ group. All authors were not precluded from accessing data in the study, and they accept responsibility to submit for publication. All authors have read and approved the final manuscript.
Financial disclosure
This study was an investigator-initiated trial funded by CanariaBio. CanariaBio supported the study with providing the investigational products (Oregovomab) and part of funding. This work was also supported by grants from the National Research Foundation of the Republic of Korea (NRF-2021R1A2C1093502 to J Park). J-Y Lee received grants and personal fees from Canariabio, Beigene, Bergenbio, Clovis Oncology, Immunogen, Janssen, Merck, MSD, Novartis, Roche, Seagen, Synthon and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Writing disclosure
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that the protocol has been approved by each participating institutional review board (IRB) before initiating patient accrual at each institution: IRB of Yonsei University (No. 4-2022-0430), IRB of Korea University Guro Hospital (No. 2023GR0068), IRB of National Cancer Center (No. NCC2023-0162) and IRB of Samsung Medical Center (No. 2022-04-006). The study will be performed in accordance with the ethical principles of the Declaration of Helsinki and conducted in adherence to the study protocol, applicable Good Clinical Practices and applicable laws and country-specific regulations in which the study is being conducted. Written informed consent will be obtained from all patients before any study-related procedures are conducted.
Data availability statement
The raw clinical and imaging data are protected by patient privacy laws. The datasets generated and/or analyzed during the study are available from the corresponding author, J-Y Lee, on request, and de-identified clinical data and experimental data are available on request sharing, which will require the approval of the institutional ethical committees. De-identified data will then be transferred to the investigator via secure file transfer.