Phase 2 study of copanlisib for tumors with PIK3CA mutations

PIK3CA is the most commonly mutated oncogene with alterations observed across multiple tumor types including breast, ovarian, and colon. NCI-MATCH is a tumor-agnostic platform trial that enrolls patients to targeted therapies on the basis of matching genomic alterations. Arm Z1F of the study evaluated the α and δ PI3K inhibitor copanlisib for tumors with PIK3CA mutations. Sixty-eight percent of patients had three or more lines of prior therapy. The study met its primary end point with an ORR of 16% (p=0.0341 against a null rate of 5%). The authors conclude that copanlisib had clinical activity in select tumors with PIK3CA mutation in the refractory setting.