Safety and antitumor activity of copanlisib in Japanese patients with relapsed/refractory indolent non-Hodgkin lymphoma: a phase Ib/II study

Noriko Fukuhara, Dai Maruyama, Kiyohiko Hatake, Hirokazu Nagai, Shinichi Makita, Kenjiro Kamezaki, Toshiki Uchida, Shigeru Kusumoto, Junya Kuroda, Chisako Iriyama, Masamitsu Yanada, Norifumi Tsukamoto, Youko Suehiro, Hironobu Minami, Jose Garcia-Vargas, Barrett H. Childs, Masanobu Yasuda, Shigeo Masuda, Toshiaki Tsujino, Yui TeraoKensei Tobinai

Research output: Contribution to journalArticlepeer-review

Abstract

The safety, efficacy, and pharmacokinetics of copanlisib were evaluated in this phase Ib/II study in Japanese patients with relapsed/refractory indolent non-Hodgkin lymphoma (NHL). The primary endpoint was safety at the recommended dose; efficacy endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival. In phase Ib, patients received copanlisib 45 mg intravenously on days 1, 8, and 15 of a 28-day cycle, and when tolerated, consecutive patients received copanlisib 60 mg. As no dose-limiting toxicities occurred at the 45 mg (n = 3) or 60 mg (n = 7) dose in phase Ib, the recommended dose for Japanese patients was determined to be 60 mg, and this dose was used in phase II (n = 15). Although all patients experienced at least one treatment-emergent adverse event (TEAE), with hyperglycemia being the most common AE, no AE-related deaths were reported. The ORR was 68.0% (17/25 patients), median PFS was 302 (95% CI 231–484) days, and the duration of response was 330 (range 65–659) days. The pharmacokinetic properties of copanlisib were similar between Japanese and non-Japanese patients. Overall, copanlisib 60 mg had an acceptable safety profile and showed promising antitumor activity in Japanese patients with relapsed/refractory indolent NHL.

Original languageEnglish
JournalInternational Journal of Hematology
DOIs
Publication statusAccepted/In press - 2022
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Hematology

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