|The following article features coverage from the European Hematology Association (EHA) 2021 Virtual Congress. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Compared with placebo, adding copanlisib to rituximab appears to improve outcomes in patients with relapsed, indolent non-Hodgkin lymphoma (NHL), according to research presented at the European Hematology Association (EHA) 2021 Virtual Congress.
Patients with relapsed, advanced, and indolent NHL are often treated with rituximab-based therapy combinations, which are considered standard of care in this setting. Copanlisib is a PI3K inhibitor that previously demonstrated strong outcomes in, and was consequently approved for, patients with pretreated, relapsed follicular lymphoma.
The phase 3 CHRONOS-3 study (ClinicalTrials.gov Identifier: NCT02367040) compared the safety and efficacy of rituximab plus copanlisib with rituximab plus placebo in patients with relapsed, indolent NHL. The primary data from the trial were presented.
Enrolled patients (458; median age, 63 years) were randomly assigned 2:1 to the copanlisib group (307 patients) or the placebo group (151 patients). All patients had relapsed, indolent disease, and had not been on treatment and had not had disease progression for at least 12 months after receiving a rituximab-based treatment. The study’s primary endpoint was progression-free survival (PFS).
The majority of patients (60%) had follicular lymphoma, 20.7% had marginal zone lymphoma, 10.9% had small lymphocytic lymphoma, and 8.3% had lymphoplasmacytic lymphoma/Waldenström macroglobulinemia.
The median follow-up was 19.2 months. Copanlisib was associated with a lower risk of both progression and mortality (hazard ratio, 0.52; P < .001), with a median PFS of 21.5 months compared with 13.8 months in the placebo group. These reductions in progression and mortality risk were noted regardless of histology.
The overall response and complete response rates in the copanlisib group were 81% and 34%, respectively, compared with 48% and 15%, respectively, in the placebo group. The median overall survival was not estimable.
The most common grade 3 or worse treatment-related adverse events (AEs) in the copanlisib group were hyperglycemia (56.4%), hypertension (39.7%), and diarrhea (4.9%). More serious AEs were noted in the copanlisib group (47.2%) than in the placebo group (18.5%).
Six (2%) patients had a grade 5 treatment-related AE vs 1 (0.7%) patient in the placebo group.
Disclosure: The presenter declared affiliations with AbbVie, ADC Therapeutics, Bristol Myers Squibb, Celgene, Celltrion, EUSA Pharma, Gilead, Immune Design, Incyte, Janssen, Janssen-Cilag, Kyowa Kirin, Merck, MSD, Portola, Roche, Sandoz, Servier, Takeda, TG Therapeutics, and Verastem.
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Zinzani PL, Capra M, Özcan M, et al. CHRONOS-3: randomized phase III study of copanlisib plus rituximab vs rituximab/placebo in relapsed indolent non-Hodgkin lymphoma. Paper presented at: European Hematology Association 2021 Virtual Congress; June 2021; Abstract S211.