دورية أكاديمية
Results from a phase 1b/2 study of ibrutinib combination therapy in advanced urothelial carcinoma
| العنوان: | Results from a phase 1b/2 study of ibrutinib combination therapy in advanced urothelial carcinoma |
|---|---|
| المؤلفون: | Mar, Nataliya, Zakharia, Yousef, Falcon, Alejandro, Morales-Barrera, Rafael, Mellado, Begona, Duran, Ignacio, Oh, Do-Youn, Williamson, Stephen K., Gajate, Pablo, Arkenau, Hendrik-Tobias, Jones, Robert J., Teo, Min Yuen, Turan, Tolga, McLaughlin, Robert T., Peltier, Hillary M., Chong, Elizabeth, Atluri, Harisha, Dean, James P., Castellano, Daniel |
| بيانات النشر: | MDPI |
| سنة النشر: | 2023 |
| المجموعة: | University of Glasgow: Enlighten - Publications |
| الوصف: | Ibrutinib is a first-in-class Bruton’s tyrosine kinase inhibitor approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. We evaluated the safety and efficacy of ibrutinib, alone or combined with standard-of-care regimens, in adults with advanced urothelial carcinoma (UC). Once-daily ibrutinib was administered orally at 840 mg (single-agent or with paclitaxel) or at 560 mg (with pembrolizumab). Phase 1b determined the recommended phase 2 dose (RP2D) of ibrutinib, and phase 2 assessed progression-free survival (PFS), overall response rate (ORR), and safety. Thirty-five, eighteen, and fifty-nine patients received ibrutinib, ibrutinib plus pembrolizumab, and ibrutinib plus paclitaxel at the RP2D, respectively. Safety profiles were consistent with those of the individual agents. The best-confirmed ORRs were 7% (two partial responses) with single-agent ibrutinib and 36% (five partial responses) with ibrutinib plus pembrolizumab. Median PFS was 4.1 months (range, 1.0–37.4+) with ibrutinib plus paclitaxel. The best-confirmed ORR was 26% (two complete responses). In previously treated patients with UC, ORR was higher with ibrutinib plus pembrolizumab than with either agent alone (historical data in the intent-to-treat population). ORR with ibrutinib plus paclitaxel was greater than historical values for single-agent paclitaxel or ibrutinib. These data warrant further evaluation of ibrutinib combinations in UC. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| العلاقة: | https://eprints.gla.ac.uk/300169/1/300169.pdfTest; Mar, N. et al. (2023) Results from a phase 1b/2 study of ibrutinib combination therapy in advanced urothelial carcinoma. Cancers , 15(11), 2978. (doi:10.3390/cancers15112978 ) (PMID:37296940) (PMCID:PMC10251876) |
| الإتاحة: | https://doi.org/10.3390/cancers15112978Test https://eprints.gla.ac.uk/300169Test/ https://eprints.gla.ac.uk/300169/1/300169.pdfTest |
| حقوق: | cc_by_4 |
| رقم الانضمام: | edsbas.67EC9C61 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |