In a Chinese phase II trial (INOVA) reported in The Lancet Oncology, Peng et al found that the combination of sintilimab and bevacizumab showed activity in patients with relapsed or persistent ovarian clear cell carcinoma.
Study Details
In the multicenter trial, 37 evaluable patients with exposure to at least one cycle of platinum-containing chemotherapy were enrolled between April 2021 and July 2023. Patients received sintilimab at 200 mg and bevacizumab at 15 mg/kg intravenously every 3 weeks until disease progression. The primary endpoint was objective response rate on independent central review.
Key Findings
Median follow-up was 16.9 months (interquartile range = 7.5–23.4 months).
Objective responses were observed in 15 of 37 patients (40.5%, 95% confidence interval [CI] = 24.8%–57.9%), with a complete response in 5 (14%). Stable disease was observed in an additional 12 patients (32%), yielding a disease control rate of 73%. Median duration of response was 22.2 months (95% CI = 5.9 months to not reached).
Median progression-free survival was 6.9 months (95% CI = 5.3–8.1 months). Median overall survival was 28.2 months (95% CI = 23.8 months to not reached). The 24-month overall survival rate was 60.4% (95% CI = 42.5%–85.7%). Ten deaths were recorded.
Among 41 patients who received at least one dose of study medication, 3 (7%) had grade 3 treatment-related adverse events (proteinuria, myocarditis, and rash); no treatment-related grade 4 or 5 adverse events were reported. Treatment-related serious adverse events occurred in two patients (5%; immune-related myocarditis in one and hypertension and renal dysfunction in one).
The investigators concluded: “Sintilimab in combination with bevacizumab showed promising antitumor activity and manageable safety in patients with relapsed or persistent ovarian clear cell carcinoma. Larger, randomized trials are warranted to compare this low-toxicity, chemotherapy-free combinatorial regimen with standard chemotherapy.”
Qinglei Gao, MD, of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, is the corresponding author of The Lancet Oncology article.
Disclosure: The study was funded by the National Key Technology Research and Development Program of China, National Natural Science Foundation of China, Innovent Biologics, and others. For full disclosures of all study authors, visit TheLancet.com.
