Abstract 762P
Background
Optimal tumor reduction surgery is crucial for for advanced ovarian cancer (OC) prognosis. Neoadjuvant chemotherapy can increase surgery chances for OC, but the benefit to patients (pts) is limited. PARP inhibitors combined with anti-angiogenic drugs have significant benefits in the first-line maintenance and recurrence treatment of OC. This study aims to evaluate the efficacy and safety of Pamiparib combined with Surufatinib neoadjuvant therapy (NAT) for advanced unresectable OC in the entire population.
Methods
This is a single-center, single-arm, phase II study following Simon's two-stage design. 20 pts with newly diagnosed unresectable (Fagotti score ≥ 8 or upper abdominal CT score ≥ 3) FIGO III-IV OC were recruited. Enrolled pts will receive NAT with Pamiparib (40 mg bid q3w for 3 cycles) combined with Surufatinib (250mg bid q3w for 2 cycles), followed by interval debulking surgery (IDS) and4 cycles of platinum-containing chemotherapy. The primary endpoint is complete resection rate (R0), and secondary endpoints include objective response rate (ORR), pathologic complete response(pCR) rate, progression-free survival, overall survival, and safety.
Results
As of Aug 30, 2023, of the 20 enrolled pts, 16 had completed genetic testing, and 14 were homologous recombination deficiency (HRD) positive, with 9 cases of BRCA1/2 mutations. By Aug 30, 2023, 17 pts completed NAT and IDS with an ORR of 100%. 15 pts achieved R0 surgery (88.24%), and 2 pts achieved R1. All 20 pts were evaluable by GCIG CA125 criteria, and CA125 response was all observed (100%). Grade 3 or 4 treatment-related adverse events that occurred are neutropenia, thrombocytopenia, anemia, and hepatic dysfunction.
Conclusions
Pamiparib combined with Surufatinib as a new neoadjuvant "chemotherapy-free" regimen showed extremely high R0 and ORR rates with manageable toxicity profiles. Currently, the experiment is still ongoing and further analysis and reporting of more data will be conducted.
Clinical trial identification
NCT05652283, Release date: 6 December 2022.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
BeiGene, Ltd. and HUTCHMED (China) Limited.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
800P - Response to chemotherapy following PARP inhibition in UK ovarian cancer (OC) patients
Presenter: Sarah Howlett
Session: Poster session 11
802P - Real-world data of olaparib maintenance therapy in patients with BRCA-mutated platinum-sensitive relapsed ovarian cancer: Final results of the C-PATROL study
Presenter: Frederik Marmé
Session: Poster session 11
803P - Pre-treatment systemic inflammatory markers predict survival in endometrial cancer cases: A Japanese gynaecologic oncology group 2043 exploratory data analysis
Presenter: Shin Nishio
Session: Poster session 11
805P - Tumor-informed ctDNA detection as a predictive marker for postoperative residual disease in epithelial ovarian cancer: A feasibility study
Presenter: Christoph Grimm
Session: Poster session 11
806P - Pilot ambulatory malignant bowel obstruction (MBO) electronic monitoring program in patients with gynecologic cancers
Presenter: Ainhoa Madariaga Urrutia
Session: Poster session 11
807P - Predicting surgical outcomes in patients with advanced ovarian cancer through MRI based preoperative evaluation
Presenter: Shujuan Liu
Session: Poster session 11
808P - Cell-free human papillomavirus (HPV) DNA is a sensitive biomarker for monitoring treatment response and for detecting relapse in locally advanced cervical cancer
Presenter: Lars Sivars
Session: Poster session 11
809P - Mental and socioeconomic burden in endometrial and cervical cancer patients: A Swedish population-based study of survivorship
Presenter: jiangrong wang
Session: Poster session 11
810P - The influence of preoperative conization (pc) to patient’s (pts) outcome and tumor biology of cervical cancer (CC)
Presenter: Dimitra Trantaki
Session: Poster session 11
811P - Epidemiological landscape of cervical cancer in Latin America: EVITA LATAM (LACOG 0820)
Presenter: Graziela Zibetti Dal Molin
Session: Poster session 11