Discussion
hypertension, NHL
HYPERGLYCEMIA, HYPERTENSION, NHL
This phase Ib/II study demonstrated that the recommended dose of copanlisib is 60 mg in Japanese patients with relapsed/refractory indolent NHL, and that the safety and tolerability of copanlisib, as well as the antitumor activity, in this population are similar to those reported in the CHRONOS-1 study [In our study, copanlisib was associated with an ORR of 68.0% and median duration of response of almost 1 year (330 days or 10.8 months), compared with an ORR of 60.6% and median duration of response of 14.1 months in CHRONOS-1 [Hyperglycemia and hypertension were common AEs with copanlisib in our study, consistent with previous data for copanlisib monotherapy [Of the five patients with hypertension who were able to continue copanlisib for more than 1 year, three patients developed hypertension within the first month of treatment (grade 3, Our study has some limitations which need to be acknowledged. As a phase Ib/II study, a small number of patients were enrolled. Almost all of these patients had FL, so the results should be confirmed in larger studies in patients with other types of indolent NHL.In conclusion, this study indicates that copanlisib, at a recommended dose of 60 mg, has an acceptable safety and tolerability profile, and showed promising antitumor activity in Japanese patients with relapsed/refractory indolent NHL.