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A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia
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| Zeitschriftentitel: | Cancer Science |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , , , , |
| In: | Cancer Science, 111, 2020, 9, S. 3327-3337 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
Wiley
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| Schlagwörter: |
| author_facet |
Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji |
|---|---|
| author |
Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji |
| spellingShingle |
Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji Cancer Science A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia Cancer Research Oncology General Medicine |
| author_sort |
sekiguchi, naohiro |
| spelling |
Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji 1347-9032 1349-7006 Wiley Cancer Research Oncology General Medicine http://dx.doi.org/10.1111/cas.14561 <jats:title>Abstract</jats:title><jats:p>Tirabrutinib is a second‐generation Bruton’s tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment‐naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström’s macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression‐free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the <jats:italic>MYD88<jats:sup>L265P</jats:sup></jats:italic> mutation. MRR and ORR were 88.9% and 96.3%, respectively (Cohort A: MRR, 88.9%; ORR, 94.4%; Cohort B: MRR, 88.9%; ORR, 100%). Median TTMR was 1.87 mo. PFS and OS were not reached with a median follow‐up of 6.5 and 8.3 mo for Cohorts A and B, respectively. The most common adverse events (AEs) were rash (44.4%), neutropenia (25.9%), and leukopenia (22.2%), with most AEs classified as grade 1 or 2. Grade ≥ 3 AEs included neutropenia (11.1%), lymphopenia (11.1%), and leukopenia (7.4%). No grade 5 AEs were noted. All bleeding events were grade 1; none were associated with drug‐related atrial fibrillation or hypertension. Although the follow‐up duration was relatively short, the study met the primary endpoint. Therefore, tirabrutinib monotherapy is considered to be highly effective for both untreated and relapsed/refractory WM with a manageable safety profile. (JapicCTI‐173646).</jats:p> A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia Cancer Science |
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| title |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_unstemmed |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_full |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_fullStr |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_full_unstemmed |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_short |
A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_sort |
a multicenter, open‐label, phase ii study of tirabrutinib (ono/gs‐4059) in patients with waldenström’s macroglobulinemia |
| topic |
Cancer Research Oncology General Medicine |
| url |
http://dx.doi.org/10.1111/cas.14561 |
| publishDate |
2020 |
| physical |
3327-3337 |
| description |
<jats:title>Abstract</jats:title><jats:p>Tirabrutinib is a second‐generation Bruton’s tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment‐naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström’s macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression‐free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the <jats:italic>MYD88<jats:sup>L265P</jats:sup></jats:italic> mutation. MRR and ORR were 88.9% and 96.3%, respectively (Cohort A: MRR, 88.9%; ORR, 94.4%; Cohort B: MRR, 88.9%; ORR, 100%). Median TTMR was 1.87 mo. PFS and OS were not reached with a median follow‐up of 6.5 and 8.3 mo for Cohorts A and B, respectively. The most common adverse events (AEs) were rash (44.4%), neutropenia (25.9%), and leukopenia (22.2%), with most AEs classified as grade 1 or 2. Grade ≥ 3 AEs included neutropenia (11.1%), lymphopenia (11.1%), and leukopenia (7.4%). No grade 5 AEs were noted. All bleeding events were grade 1; none were associated with drug‐related atrial fibrillation or hypertension. Although the follow‐up duration was relatively short, the study met the primary endpoint. Therefore, tirabrutinib monotherapy is considered to be highly effective for both untreated and relapsed/refractory WM with a manageable safety profile. (JapicCTI‐173646).</jats:p> |
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| author | Sekiguchi, Naohiro, Rai, Shinya, Munakata, Wataru, Suzuki, Kenshi, Handa, Hiroshi, Shibayama, Hirohiko, Endo, Tomoyuki, Terui, Yasuhito, Iwaki, Noriko, Fukuhara, Noriko, Tatetsu, Hiro, Iida, Shinsuke, Ishikawa, Takayuki, Shiibashi, Ryota, Izutsu, Koji |
| author_facet | Sekiguchi, Naohiro, Rai, Shinya, Munakata, Wataru, Suzuki, Kenshi, Handa, Hiroshi, Shibayama, Hirohiko, Endo, Tomoyuki, Terui, Yasuhito, Iwaki, Noriko, Fukuhara, Noriko, Tatetsu, Hiro, Iida, Shinsuke, Ishikawa, Takayuki, Shiibashi, Ryota, Izutsu, Koji, Sekiguchi, Naohiro, Rai, Shinya, Munakata, Wataru, Suzuki, Kenshi, Handa, Hiroshi, Shibayama, Hirohiko, Endo, Tomoyuki, Terui, Yasuhito, Iwaki, Noriko, Fukuhara, Noriko, Tatetsu, Hiro, Iida, Shinsuke, Ishikawa, Takayuki, Shiibashi, Ryota, Izutsu, Koji |
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| description | <jats:title>Abstract</jats:title><jats:p>Tirabrutinib is a second‐generation Bruton’s tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment‐naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström’s macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression‐free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the <jats:italic>MYD88<jats:sup>L265P</jats:sup></jats:italic> mutation. MRR and ORR were 88.9% and 96.3%, respectively (Cohort A: MRR, 88.9%; ORR, 94.4%; Cohort B: MRR, 88.9%; ORR, 100%). Median TTMR was 1.87 mo. PFS and OS were not reached with a median follow‐up of 6.5 and 8.3 mo for Cohorts A and B, respectively. The most common adverse events (AEs) were rash (44.4%), neutropenia (25.9%), and leukopenia (22.2%), with most AEs classified as grade 1 or 2. Grade ≥ 3 AEs included neutropenia (11.1%), lymphopenia (11.1%), and leukopenia (7.4%). No grade 5 AEs were noted. All bleeding events were grade 1; none were associated with drug‐related atrial fibrillation or hypertension. Although the follow‐up duration was relatively short, the study met the primary endpoint. Therefore, tirabrutinib monotherapy is considered to be highly effective for both untreated and relapsed/refractory WM with a manageable safety profile. (JapicCTI‐173646).</jats:p> |
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| spelling | Sekiguchi, Naohiro Rai, Shinya Munakata, Wataru Suzuki, Kenshi Handa, Hiroshi Shibayama, Hirohiko Endo, Tomoyuki Terui, Yasuhito Iwaki, Noriko Fukuhara, Noriko Tatetsu, Hiro Iida, Shinsuke Ishikawa, Takayuki Shiibashi, Ryota Izutsu, Koji 1347-9032 1349-7006 Wiley Cancer Research Oncology General Medicine http://dx.doi.org/10.1111/cas.14561 <jats:title>Abstract</jats:title><jats:p>Tirabrutinib is a second‐generation Bruton’s tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment‐naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström’s macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression‐free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the <jats:italic>MYD88<jats:sup>L265P</jats:sup></jats:italic> mutation. MRR and ORR were 88.9% and 96.3%, respectively (Cohort A: MRR, 88.9%; ORR, 94.4%; Cohort B: MRR, 88.9%; ORR, 100%). Median TTMR was 1.87 mo. PFS and OS were not reached with a median follow‐up of 6.5 and 8.3 mo for Cohorts A and B, respectively. The most common adverse events (AEs) were rash (44.4%), neutropenia (25.9%), and leukopenia (22.2%), with most AEs classified as grade 1 or 2. Grade ≥ 3 AEs included neutropenia (11.1%), lymphopenia (11.1%), and leukopenia (7.4%). No grade 5 AEs were noted. All bleeding events were grade 1; none were associated with drug‐related atrial fibrillation or hypertension. Although the follow‐up duration was relatively short, the study met the primary endpoint. Therefore, tirabrutinib monotherapy is considered to be highly effective for both untreated and relapsed/refractory WM with a manageable safety profile. (JapicCTI‐173646).</jats:p> A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia Cancer Science |
| spellingShingle | Sekiguchi, Naohiro, Rai, Shinya, Munakata, Wataru, Suzuki, Kenshi, Handa, Hiroshi, Shibayama, Hirohiko, Endo, Tomoyuki, Terui, Yasuhito, Iwaki, Noriko, Fukuhara, Noriko, Tatetsu, Hiro, Iida, Shinsuke, Ishikawa, Takayuki, Shiibashi, Ryota, Izutsu, Koji, Cancer Science, A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia, Cancer Research, Oncology, General Medicine |
| title | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_full | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_fullStr | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_full_unstemmed | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_short | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| title_sort | a multicenter, open‐label, phase ii study of tirabrutinib (ono/gs‐4059) in patients with waldenström’s macroglobulinemia |
| title_unstemmed | A multicenter, open‐label, phase II study of tirabrutinib (ONO/GS‐4059) in patients with Waldenström’s macroglobulinemia |
| topic | Cancer Research, Oncology, General Medicine |
| url | http://dx.doi.org/10.1111/cas.14561 |