Six-year safety and efficacy results from the CHRONOS-1 study of the PI3K inhibitor copanlisib in patients with relapsed or refractory follicular lymphoma

7535Background: Follicular lymphoma (FL) is the most common indolent non-Hodgkin lymphoma (iNHL) subtype, yet treatment options in the relapsed/refractory (r/r) setting are limited. Copanlisib is a pan-Class I phosphatidylinositol 3-kinase (PI3K) inhibitor with predominant PI3K-α and PI3K-δ activity. We report results from the FL subset of a large phase II study (n=141) in iNHL patients (pts) (NCT01660451, part B). Methods: A total of 104 pts with indolent FL (grade 1-3a) relapsed/refractory to ≥2 prior lines of treatment were treated with copanlisib (60 mg IV infusion) administered on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was objective tumor response rate (ORR) per independent radiologic review (Cheson et al., JCO 20:579, 2007). Results: Of the 104 pts treated, 62% were refractory; median prior lines 3 (range 2-8), median time from progression 8 wks (range 1-73 wks). 52% were male, 83% white, median age 62 yrs, and 62% ECOG 0. At the time of primary analysis the ORR was 58.7%, comprisi...