HealthDay News — Copanlisib plus rituximab (C+R) reduces disease progression or death in patients with relapsed indolent non-Hodgkin lymphoma (iNHL), according to a study presented during Week 1 of the annual meeting of the American Association for Cancer Research, held virtually from April 10 to 15.
Matthew J. Matasar, MD, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported primary data from the phase III study of C+R vs placebo (P)+R in patients with relapsed iNHL. Overall, 307 and 151 patients were randomly assigned to C+R and P+R, respectively.
The researchers found that during a median follow-up of 19.2 months, the primary study end point of progression-free survival was 21.5 vs 13.8 months in the C+R and P+R groups, respectively, with a significant reduction in the risk for disease progression/death for C+R vs P+R (hazard ratio, 0.52). Reductions were seen across histology subtypes. Objective response rates (ORRs) were 80.8 and 47.7% for C+R and P+R, respectively, while complete response rates (CRRs) were 33.9 and 14.6 percent, respectively. Across all iNHL subtypes, the ORRs and CRRs were higher with C+R treatment. Hyperglycemia, hypertension, and diarrhea were the most common treatment-emergent adverse events for patients receiving C+R (69.4, 49.2, and 33.6%, respectively). Rates of serious adverse events were higher with C+R vs P+R (47.2 vs 18.5%).
“The CHRONOS-3 trial met its primary end point of progression-free survival, with improved outcomes seen in several subtypes of indolent lymphoma included in the study,” Matasar said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Bayer AG, which manufactures copanlisib and funded the trial.