دورية أكاديمية
Phase II study of novel orally PI3Kα/δ inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma
| العنوان: | Phase II study of novel orally PI3Kα/δ inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma |
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| المؤلفون: | Huaqing Wang, Jifeng Feng, Yanyan Liu, Zhengzi Qian, Da Gao, Xuehong Ran, Hui Zhou, Lihong Liu, Binghua Wang, Meiyun Fang, Hebing Zhou, Zhenqian Huang, Shi Tao, Zhuowen Chen, Liping Su, Hang Su, Yu Yang, Xiaobao Xie, Huijing Wu, Ping Sun, Guoyu Hu, Aibin Liang, Zhiming Li |
| المصدر: | Signal Transduction and Targeted Therapy, Vol 9, Iss 1, Pp 1-9 (2024) |
| بيانات النشر: | Nature Publishing Group, 2024. |
| سنة النشر: | 2024 |
| المجموعة: | LCC:Medicine LCC:Biology (General) |
| مصطلحات موضوعية: | Medicine, Biology (General), QH301-705.5 |
| الوصف: | Abstract This registration study assessed clinical outcomes of TQ-B3525, the dual phosphatidylinositol-3-kinase (PI3K) α/δ inhibitor, in relapsed and/or refractory follicular lymphoma (R/R FL). This phase II study (ClinicalTrials.gov NCT04324879. Registered March 27, 2020) comprised run-in stage and stage 2. R/R FL patients after ≥2 lines therapies received oral 20 mg TQ-B3525 once daily in a 28-day cycle until intolerable toxicity or disease progression. Primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR). Based on results (ORR, 88.0%; duration of response [DOR], 11.8 months; progression-free survival [PFS], 12.0 months) in 25 patients at run-in stage, second stage study was initiated and included 82 patients for efficacy/safety analysis. Patients received prior-line (median, 3) therapies, with 56.1% refractory to previous last therapies; 73.2% experienced POD24 at baseline. At stage 2, ORR was 86.6% (71/82; 95% CI, 77.3–93.1%), with 28 (34.2%) complete responses. Disease control rate was 95.1% due to 7 (8.5%) stable diseases. Median time to response was 1.8 months. Among 71 responders, median DOR was not reached; 18-month DOR rate was 51.6%. with median follow-up of 13.3 months, median PFS was 18.5 (95% CI, 10.2-not estimable) months. Median overall survival (OS) was not reached by cutoff date; 24-month OS rate was estimated as 86.1%. Response rates and survival data were consistent across all subgroups. Grade 3 or higher treatment-related adverse events were observed in 63 (76.8%) cases, with neutropenia (22.0%), hyperglycemia (19.5%), and diarrhea (13.4%) being common. TQ-B3525 showed favorable efficacy and safety for R/R FL patients after ≥2 lines prior therapies. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2059-3635 |
| العلاقة: | https://doaj.org/toc/2059-3635Test |
| DOI: | 10.1038/s41392-024-01798-0 |
| الوصول الحر: | https://doaj.org/article/b34bb7a2f1604af6b6438be5bc6ad089Test |
| رقم الانضمام: | edsdoj.b34bb7a2f1604af6b6438be5bc6ad089 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 20593635 |
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| DOI: | 10.1038/s41392-024-01798-0 |