Chiauranib plus weekly paclitaxel cut the risk of progression or death by 57% vs placebo plus paclitaxel in platinum-resistant or refractory ovarian cancer.
The combination of chiauranib and weekly paclitaxel significantly improved progression-free survival (PFS) compared with placebo plus weekly paclitaxel in patients with platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal cancer, according to data from the phase 3 CHIPRO trial (NCT04921527) presented at the
Per independent review committee (IRC) assessment in the intent-to-treat (ITT) population, the chiauranib plus paclitaxel (CP) group (n = 228) achieved a median PFS of 4.57 months (95% CI, 4.14-5.52) compared with 2.69 months (95% CI, 1.58-2.76) in the placebo plus paclitaxel (PP) group (n = 231; HR, 0.427; 95% CI, 0.34-0.54; P < .001), representing a 57% reduction in the risk of progression or death. Median overall survival (OS) in the ITT population was 12.09 months (95% CI, 10.51-15.18) with the CP regimen vs 12.12 months (95% CI, 10.25-13.31) with PP (HR, 0.932; 95% CI, 0.73-1.20; P = .583), a difference that did not reach statistical significance.
"CHIPRO is the first randomized study with a substantial primary platinum-refractory population, making it highly relevant to real-world practice," Xiaohua Wu, MD, of Fudan University Shanghai Cancer Center in China, said during the presentation.
CHIPRO was a randomized, double-blind, placebo-controlled phase 3 study conducted exclusively in China. Eligible patients had histologically confirmed ovarian, fallopian tube, or primary peritoneal cancer with primary platinum-refractory or platinum-resistant disease and 1 to 5 prior lines of therapy.1,2
Patients were randomly assigned 1:1 to receive chiauranib 50 mg orally once daily plus weekly paclitaxel (60 mg/m² on days 1, 8, and 15 of each 3-week cycle for up to 6 cycles) or placebo plus weekly paclitaxel, followed by maintenance with chiauranib or placebo until disease progression, unacceptable toxicity, withdrawal, or death.1 Stratification factors included the number of prior chemotherapy lines (1 or 2 vs ≥ 3) and platinum-free interval after initial platinum-based therapy (≥ 6 months vs < 6 months).
Coprimary end points were PFS by IRC per RECIST 1.1 criteria and OS. Secondary end points included investigator-assessed PFS, overall response rate (ORR), disease control rate, duration of response (DOR), quality of life, and safety.
At baseline, 45.6% of patients in the CP arm had a platinum-free interval of less than 6 months, 51.3% had received prior PARP inhibitor therapy, and 70.2% had received prior VEGF/VEGFR inhibitor therapy. The data cutoff was July 29, 2025.
Chiauranib is a selective Aurora B kinase inhibitor that also targets CSF1R, PDGFRs, DDR1, VEGFR, and PDGFR. Aurora B inhibition suppresses tumor cell proliferation via G2/M arrest and apoptosis induction, whereas coinhibition of CSF1R/PDGFRs/DDR1 is intended to reprogram the suppressive immune microenvironment, and VEGFR/PDGFR inhibition blocks angiogenesis.
The ORR by IRC in the ITT population was 32.0% (95% CI, 26.01%-38.50%) with the CP regimen vs 14.3% (95% CI, 10.04%-19.47%) with PP (P < .001), including complete response rates of 0.4% in each arm and partial response rates of 31.6% vs 13.9%. By investigator assessment, ORR was 35.5% (95% CI, 29.32%-42.11%) vs 13.4% (95% CI, 9.30%-18.50%; P < .001). Median DOR by IRC was 5.52 months (95% CI, 4.17-6.93) vs 4.14 months (95% CI, 2.69-4.37; P = .093). Tumor reduction of any magnitude was observed in 76.8% of patients in the CP arm vs 42.4% in the PP arm.
The safety profile of chiauranib plus weekly paclitaxel was consistent with the known profiles of each agent, with no new safety signals identified. Treatment-emergent adverse events (TEAEs) of any grade occurred in 100% of patients in the CP arm vs 98.3% in the PP arm. Grade 3 or higher TEAEs were observed in 90.4% vs 54.3% of patients, respectively. TEAEs led to interruption of chiauranib or placebo in 68.4% vs 32.6%, dose reduction in 37.3% vs 12.6%, and discontinuation in 6.1% vs 4.8%; the most common TEAE leading to discontinuation in the CP arm was neutropenia (1.3%). Serious AEs occurred in 32.5% vs 14.3% of patients. Seven patients (3.1%) in the CP arm died due to AEs, with 4 cases (1.8%) considered possibly treatment-related. Hematologic abnormalities—including leukopenia, neutropenia, and anemia—were the most common TEAEs in the CP arm.
