Phase III CHRONOS-3 trial of Aliqopa and Rituxan in non-Hodgkin’s Lymphoma published in The Lancet Oncology.- Bayer HealthCare

Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa (copanlisib), from Bayer HealthCare, and Rituxan (rituximab) given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study. In addition to the primary endpoint of PFS, data on the secondary endpoints of ORR and complete response rate (CRR) will also be presented. Best ORR for the combination of Aliqopa and rituximab was 80.8% (95% CI 76, 85) versus 47.7% (95% CI 40, 56) for rituximab and placebo (p<0.0001), with 33.9% and 14.6% of patients achieving cr, respectively. of the relapsed inhl patients included in the trial, 60% had fl, 20.7% marginal zone lymphoma (mzl), 10.9% small lymphocytic lymphoma (sll) and 8.3% lymphoplasmacytoid lymphoma waldenström macroglobulinemia (lpl wm). analysis of the subtypes will be presented at aacr and published in the lancet oncology. all-grade treatment-emergent adverse events (teaes) observed with the aliqopa and rituximab combination that occurred in more than 20% of the patients included hyperglycemia (69.4%) and hypertension (49.2%).chronos-3 is a phase iii randomized, double-blind, placebo-controlled trial with the objective to evaluate whether aliqopa in combination with rituximab is superior to placebo plus rituximab in extending pfs in patients with relapsed inhl following at least one prior rituximab-containing therapy. the data will be presented in a clinical trials plenary session on april 10 at the virtual american association for cancer research (aacr) annual meeting 2021 and simultaneously published in the lancet oncology.see: "copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-hodgkin lymphoma (chronos-3): a double-blind, randomised, placebo-controlled, phase 3 trial." matthew j matasar et al. the lancet oncology april 10, 2021doi:https: doi.org 10.1016 s1470-2045(21)00145-5>