Copanlisib in non-Hodgkin's lymphoma and solid tumors: An efficacy and safety analysis

Introduction: Copanlisib is an intravenous pan-class I PI3K inhibitor with predominant activity against the α and δ isoforms. We conducted this review to assess the efficacy and safety of copanlisib in patients with relapsed or refractory nonHodgkin’s lymphoma (NHL) and other solid tumors. Methods: A systematic search of the electronic database (PubMed, Cochrane, Clinicaltrials.gov, Google scholar, and China National Knowledge Infrastructure) was conducted for relevant studies. Any clinical trial with clear outcome measures on the efficacy or safety of copanlisib in NHL or other solid tumors were eligible for inclusion. The objective response rate (ORR) and the complete response (CR) rate were used to assess the efficacy. Incidence of all grade and grade 3–4 treatmentemergent adverse events (TEAE) were calculated to evaluate the safety profile. Results: We analyzed seven single-arm prospective clinical trials. The pooled ORR was 39.1% (95% CI: 21.0–60.7%) for NHL cohort. The pooled CR rate for NHL was 10.9% (95% CI: 6.9–16.8%). Indolent NHL had a higher rate of response than aggressive NHL (ORR 56.9% vs. 22.8%; CR rate 15.8% vs. 7.6%). The pooled incidence rate of grade 3–4 TEAE was 73.9% (95% CI: 66.4–80.3%). Most common grade 3–4 TEAE were: hyperglycemia (31.4%), hypertension (29.8%), neutropenia (18.3%), anemia (7.4%), and pneumonia (6.8%). Conclusions: Copanlisib is effective in the treatment of relapsed or refractory NHL, with a higher rate of response in indolent NHL than aggressive NHL. Hyperglycemia and hypertension were the most common adverse events.