A phase II trial conducted in China, named INOVA, has revealed that the combination of sintilimab and bevacizumab exhibits promising activity in patients suffering from relapsed or persistent ovarian clear cell carcinoma. The study, published in The Lancet Oncology, offers a potential chemotherapy-free option for this challenging cancer type.
Study Details and Key Findings
The multicenter trial enrolled 37 evaluable patients who had previously undergone at least one cycle of platinum-containing chemotherapy. Participants were administered sintilimab at 200 mg and bevacizumab at 15 mg/kg intravenously every three weeks until disease progression. The primary endpoint was the objective response rate as assessed by independent central review.
After a median follow-up of 16.9 months (interquartile range: 7.5–23.4 months), the study reported an objective response rate of 40.5% (95% CI: 24.8%–57.9%), with 14% achieving a complete response. An additional 32% of patients experienced stable disease, resulting in a disease control rate of 73%. The median duration of response was 22.2 months (95% CI: 5.9 months to not reached).
The median progression-free survival was 6.9 months (95% CI: 5.3–8.1 months), while the 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%).
Safety Profile
Among the 41 patients who received at least one dose of the study medication, 7% experienced grade 3 treatment-related adverse events, including proteinuria, myocarditis, and rash. No treatment-related grade 4 or 5 adverse events were reported. Treatment-related serious adverse events occurred in 5% of patients, including one case of immune-related myocarditis and another of hypertension and renal dysfunction.
Expert Commentary
The study investigators concluded that the combination of sintilimab and bevacizumab demonstrated promising antitumor activity and a manageable safety profile in patients with relapsed or persistent ovarian clear cell carcinoma. They advocate for larger, randomized trials to compare this low-toxicity, chemotherapy-free regimen with standard chemotherapy approaches.
