Gynecologic oncology · 2025
Low-dose lenvatinib plus toripalimab for patients with platinum-resistant recurrent ovarian cancer: preliminary results from a multicenter, phase II trial (NCT06241105).
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Su Hao, Shang Xiao, Liu Hongruo, Tian Mingle, Yu Yang, Xu Yanhua, Jiang Kui, Feng Fengzhi
Аннотация
OBJECTIVE: Platinum-resistant ovarian cancer (PROC) remains a therapeutic challenge. While immune checkpoint inhibitor plus lenvatinib demonstrates potential efficacy in ovarian cancer, the standard 20 mg lenvatinib dosage causes significant adverse events leading to treatment disruption. We present preliminary results of a multicenter, single-arm phase II trial evaluating low-dose lenvatinib plus toripalimab for recurrent PROC.
METHODS: Patients with recurrent PROC received low-dose lenvatinib (8 or 12 mg daily) and toripalimab (240 mg, every three weeks). Primary endpoint was progression-free survival (PFS). Second endpoints included objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), and safety.
RESULTS: Thirty-three patients were enrolled at preliminary analysis. 91 % were platinum-resistant, and 9 % were platinum-refractory, with a median of 3 prior therapy lines (range 1-12). Median (95 % CI) PFS and OS were 5.0 months (3.8-6.2) and 13.3 months (12.4-14.2), respectively. Patients with CA125 decrease ≥50 % after the first cycle had longer PFS (7.9 vs 3.7 months). The ORR was 27 % (95 % CI 13 %-46 %) and DCR was 54 % (95 % CI 36 %-72 %). Median DOR was 4.4 months (range 2.1- ≥ 17.4). Treatment-related adverse events occurred in 97 % of patients (39 % grade 3; no grade 4-5). Four (12 %) patients required lenvatinib dose reduction, with treatment interruption and discontinuation rates of 42 % and 12 %, respectively. Patients who underwent platinum rechallenge following progression on trial treatment appeared to regain platinum sensitivity.
CONCLUSIONS: Low-dose lenvatinib plus toripalimab demonstrated encouraging efficacy and tolerability in patients with heavily pretreated, recurrent PROC. Completed accrual is needed to confirm these results.
METHODS: Patients with recurrent PROC received low-dose lenvatinib (8 or 12 mg daily) and toripalimab (240 mg, every three weeks). Primary endpoint was progression-free survival (PFS). Second endpoints included objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), and safety.
RESULTS: Thirty-three patients were enrolled at preliminary analysis. 91 % were platinum-resistant, and 9 % were platinum-refractory, with a median of 3 prior therapy lines (range 1-12). Median (95 % CI) PFS and OS were 5.0 months (3.8-6.2) and 13.3 months (12.4-14.2), respectively. Patients with CA125 decrease ≥50 % after the first cycle had longer PFS (7.9 vs 3.7 months). The ORR was 27 % (95 % CI 13 %-46 %) and DCR was 54 % (95 % CI 36 %-72 %). Median DOR was 4.4 months (range 2.1- ≥ 17.4). Treatment-related adverse events occurred in 97 % of patients (39 % grade 3; no grade 4-5). Four (12 %) patients required lenvatinib dose reduction, with treatment interruption and discontinuation rates of 42 % and 12 %, respectively. Patients who underwent platinum rechallenge following progression on trial treatment appeared to regain platinum sensitivity.
CONCLUSIONS: Low-dose lenvatinib plus toripalimab demonstrated encouraging efficacy and tolerability in patients with heavily pretreated, recurrent PROC. Completed accrual is needed to confirm these results.