Cancer medicine · 2026
Safety, Tolerability, and Pharmacokinetics of Mirvetuximab Soravtansine in Chinese Patients With Folate Receptor α-Positive Advanced Ovarian Cancer.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Li Yongsheng, Yuan Li, Lou Ge, Cai Hongbing, Li Yuzhi, Li Fenghu, Wang Li, Long Xingtao, Gong Yi, Zhu Chaonan, Li Li, Xu June, Zhou Qi
Аннотация
BACKGROUND: Folate receptor α (FRα) is a glycosylphosphatidylinositol-anchored protein that facilitates folate transport and has emerged as a promising therapeutic target for ovarian cancer, particularly due to its association with tumor progression. This Phase I study investigated the safety, tolerability, pharmacokinetics, and preliminary efficacy of mirvetuximab soravtansine (MIRV), an antibody-drug conjugate targeting folate receptor α (FRα), in Chinese patients with FRα-overexpressed platinum-resistant ovarian cancer.
METHODS: This study enrolled 19 Chinese patients with previously treated FRα-overexpressed ovarian cancer in the dose escalation phase (5 mg/kg, n = 4; 6 mg/kg, n = 3) and dose expansion phase (n = 12). MIRV was administered in escalating doses from 5 to 6 mg/kg (adjusted ideal body weight), following a 3 + 3 dose-escalation design. The trial is registered with chinadrugtrials.org.cn (CTR20211876).
RESULTS: Median treatment exposure were 9.9 weeks for the 5 mg/kg cohort (n = 4) and 13.1 weeks for the 6 mg/kg cohort (n = 15). The most common grade ≥ 3 adverse events were decreased platelet count (21.1%), decreased lymphocyte count (15.8%), and anemia (15.8%). The plasma concentration-time and pharmacokinetic profiles of MIRV and the total antibody were generally comparable after the first and third doses. Pharmacokinetic analysis revealed a median time to maximum concentration (Tmax) of 3.33 h, mean terminal half-life (T1/2) of 118 h, and geometric mean maximum concentration (Cmax) of 137.07 μg/mL. MIRV exposures were comparable to those reported in Caucasian patients. No anti-drug antibodies were detected. Among 15 efficacy-evaluable patients with high-grade serous ovarian cancer, the objective response rate was 26.7%, with partial responses in four patients and stable disease in seven patients.
CONCLUSIONS: MIRV showed anticipated pharmacokinetics, safety, tolerability, and efficacy profiles in Chinese patients with FRα-positive platinum-resistant ovarian cancers, supporting its potential as a targeted therapeutic agent for this patient population.
TRIAL REGISTRATION: The trial is registered with chinadrugtrials.org.cn (CTR20211876).
METHODS: This study enrolled 19 Chinese patients with previously treated FRα-overexpressed ovarian cancer in the dose escalation phase (5 mg/kg, n = 4; 6 mg/kg, n = 3) and dose expansion phase (n = 12). MIRV was administered in escalating doses from 5 to 6 mg/kg (adjusted ideal body weight), following a 3 + 3 dose-escalation design. The trial is registered with chinadrugtrials.org.cn (CTR20211876).
RESULTS: Median treatment exposure were 9.9 weeks for the 5 mg/kg cohort (n = 4) and 13.1 weeks for the 6 mg/kg cohort (n = 15). The most common grade ≥ 3 adverse events were decreased platelet count (21.1%), decreased lymphocyte count (15.8%), and anemia (15.8%). The plasma concentration-time and pharmacokinetic profiles of MIRV and the total antibody were generally comparable after the first and third doses. Pharmacokinetic analysis revealed a median time to maximum concentration (Tmax) of 3.33 h, mean terminal half-life (T1/2) of 118 h, and geometric mean maximum concentration (Cmax) of 137.07 μg/mL. MIRV exposures were comparable to those reported in Caucasian patients. No anti-drug antibodies were detected. Among 15 efficacy-evaluable patients with high-grade serous ovarian cancer, the objective response rate was 26.7%, with partial responses in four patients and stable disease in seven patients.
CONCLUSIONS: MIRV showed anticipated pharmacokinetics, safety, tolerability, and efficacy profiles in Chinese patients with FRα-positive platinum-resistant ovarian cancers, supporting its potential as a targeted therapeutic agent for this patient population.
TRIAL REGISTRATION: The trial is registered with chinadrugtrials.org.cn (CTR20211876).