Preliminary efficacy and safety of first-line anlotinib plus carboplatin/paclitaxel induction therapy followed by anlotinib maintenance in advanced ovarian cancer: Results from the ALTER-GO-010 phase II multicenter trial.

Abstract

5576 Background: Several studies have shown that antiangiogenic drugs combined with chemotherapy as first-line treatment, followed by maintenance therapy with antiangiogenic agents, significantly improve outcomes for ovarian cancer patients. Anlotinib, a highly effective multi-target tyrosine kinase inhibitor targeting VEGFRs, FGFRs, PDGFRs, and c-Kit, has been approved for multiple tumor types in China. The ALTER-GO-010 study is a single-arm, multicenter phase II trial designed to assess the efficacy and safety of anlotinib in combination with carboplatin/paclitaxel as first-line induction therapy, followed by anlotinib maintenance, in patients with newly diagnosed advanced ovarian cancer. Methods: Eligible patients with newly diagnosed FIGO stage III–IV primary epithelial ovarian, fallopian tube, or primary peritoneal cancer (ECOG PS 0–1) who have undergone primary or interval debulking surgery will receive 6-8 cycles of chemotherapy (paclitaxel 175 mg/m² + carboplatin AUC 5 every 3 weeks) combined with anlotinib (12 mg orally once daily on days 1–14, 21-day cycle; omitted during the first cycle to prevent delayed wound healing). Following chemotherapy completion, anlotinib will be continued as maintenance monotherapy until disease progression, unacceptable toxicity, or death. Exclusion criteria include prior anti-angiogenic therapy or major surgery within 28 days before anlotinib initiation. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include overall survival, and safety profile. Results: As of the data cutoff date (November 30, 2025), 54 patients had received at least one dose of the study drug and were included in the analysis. The median age was 56 years, 98.11% had high-grade serous carcinoma and 1.89% had endometrioid carcinoma. 96.23% had FIGO stage III and 3.77% had stage IV. The data maturity for PFS analysis was 40.7%. The median PFS was 20.76 months (95% CI: 11.58-29.95). Patients without prior history of neoadjuvant therapy had longer mPFS than those with prior therapy. The median OS was not reached. The most common all-grade treatment emergent adverse events (TEAEs) were white blood cell deceased, anemia, neutrophil count decreased, platelet count decreased and lymphocyte count decreased. Grade ≥3 TEAEs occurred in 75.5% of patients during the chemotherapy phase and 22.7% during maintenance. No treatment-related deaths were reported. Conclusions: The preliminary efficacy and safety data suggest that anlotinib plus carboplatin/paclitaxel induction therapy, followed by anlotinib maintenance, is a promising regimen for newly diagnosed advanced ovarian cancer, with a median PFS of 20.76 months and a favorable safety profile. Clinical trial information: NCT04807166 .