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Table 2 Selected data of copanlisib monotherapy in relapsed or refractory B-cell-lymphoma subtypes in clinical trials

From: A phase II study of the PI3K inhibitor copanlisib in combination with the anti-CD20 monoclonal antibody rituximab for patients with marginal zone lymphoma: treatment rationale and protocol design of the COUP-1 trial

Trial

Subtype of lymphoma (%)

Number of patients

OR (%)

CR (%)

summary of treatment-emergent ≥ grade 3 (%) occurring in ≥10% of the total population

Phase I [18]

FL (66.6), DLBCL (33.3)

9

78%

11%

hyperglycemia (33), hypertension (33),

lung infection (22),

neutropenia (11),

rash (11),

anemia (11)

Phase II [20]

DLBCL (100)

79

19.4

5

hyperglycemia (33), hypertension (31)

Phase II [21]

FL (73),

MZL (16),

SLL 8 (6),

LPL/WM (4),

DLBCL (1)

142

59 (overall cohort),

70 (only MZL)

12 (overall cohort),

9 (only MZL)

hyperglycemia (41), hypertension (24),

lung infection (15),

neutropenia (24)

  1. FL follicular lymphoma, DLBCL diffuse large B-cell lymphoma, MZL marginal zone lymphoma, SLL small lymphocytic lymphoma, LPL lymphoplasmacytic lymphoma, WM Waldenström’s macroglobulinemia, OR overall response, CR complete response