Copanlisib: Ph II CHRONOS-1 data

Bayer said the open-label, international Phase II CHRONOS-1 trial in 142 patients with relapsed or refractory indolent B cell NHL who received ≥2 prior therapies showed that 60 mg IV copanlisib on days 1, 8 and 15 of each 28-day cycle met the primary endpoint of achieving a prespecified ORR of 40%. Specifically, copanlisib led to an ORR of 59.2%, including 17 complete responses (CRs) and 67 partial responses (PRs), plus 42 cases of stable disease (SD). The median duration of response was 22.6 months and median PFS was 11.2 months. In patients with follicular lymphoma (n=104), copanlisib led to an ORR of 58.7%, including 15 CRs and 46 PRs, plus 35 cases of SD. The median duration of response was 12.2 months and median PFS was 11.2 months. The most common treatment-related adverse events reported were transient hyperglycemia and hypertension. Data were presented at the American Association for Cancer Research meeting in Washington, D.C...