医学
套细胞淋巴瘤
伊布替尼
内科学
威尼斯人
中性粒细胞减少症
不利影响
肿瘤溶解综合征
发热性中性粒细胞减少症
临床终点
肿瘤科
临床研究阶段
进行性疾病
胃肠病学
淋巴瘤
外科
临床试验
化疗
白血病
慢性淋巴细胞白血病
作者
Hideki Goto,Satoshi Ito,Masahiro Kizaki,Masaki Yamaguchi,Noriko Fukuhara,Kôji Katô,Toko Saito,Yasuhito Terui,Sumiko Okubo,Tomomi Soshin,Jiewei Zeng,Hideyuki Honda,Mohamed Badawi,Jeremy A. Ross,Koji Izutsu
标识
DOI:10.1007/s10147-023-02443-6
摘要
Abstract Background Despite high response rates to initial therapy, most patients with mantle cell lymphoma (MCL) experience relapsed or refractory (R/R) disease. Here, we report the efficacy, safety, and pharmacokinetics of the Phase 2, single-arm M20-075 study (NCT04477486) of ibrutinib and venetoclax combination therapy in Japanese patients with R/R MCL. Methods Patients received 560 mg ibrutinib and 400 mg venetoclax (after a 5-week ramp-up from 20 mg) once daily for up to 104 weeks. Primary endpoint was complete response (CR) rate by independent review committee (IRC). Secondary endpoints included overall response rate (ORR), duration of response (DOR), undetectable minimal residual disease (uMRD) rate, progression-free survival (PFS), overall survival (OS), safety including dose-limiting toxicity (DLT) assessment in the first six patients, and pharmacokinetic parameters. Full analysis set (FAS) comprised all treated patients. Per protocol set (PPS) excluded treated patients with non-evaluable disease at baseline by IRC. Results Thirteen patients were treated (FAS n = 13; PPS, n = 12). Median age was 71 years, patients had a median of two prior treatments. After a median follow-up of 9.6 months, IRC-assessed CR rate and ORR were both 83% (PPS). All six MRD-evaluable patients had uMRD. Median DOR, PFS, and OS were unreached. The most common Grade ≥ 3 treatment-emergent adverse event (TEAE) was neutropenia (23%); 1 patient discontinued due to squamous cell carcinoma of the lung. No DLTs, tumor lysis syndrome, or deaths related to TEAEs were observed. Conclusion Ibrutinib plus venetoclax exhibited high response rates and a well-tolerated safety profile in Japanese patients with R/R MCL.
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