Copanlisib regimen extends PFS in lymphoma subset
The addition of copanlisib to rituximab extended PFS among patients with relapsed indolent non-Hodgkin lymphoma who received prior rituximab-containing therapy, according to topline data released by the agent’s manufacturer.
Copanlisib (Aliqopa, Bayer), a PI3 kinase inhibitor, received FDA approval in 2017 for treatment of adults with relapsed follicular lymphoma who received at least two prior systemic therapies.
The randomized phase 3 CHRONOS-3 trial included 458 patients with relapsed indolent non-Hodgkin lymphoma who relapsed after at least one prior line of rituximab-containing therapy. Most patients had follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma or lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia.
Researchers assigned patients to rituximab with either copanlisib or placebo.
The double-blind trial met its primary endpoint, as patients assigned the copanlisib regimen achieved significantly longer PFS.
The copanlisib-rituximab combination exhibited a safety profile consistent with previously published data on each agent alone. Researchers observed no new safety signals.
“Indolent forms of non-Hodgkin lymphoma are a heterogenous group of malignancies characterized by a chronic pattern of remissions and recurrences,” Scott Z. Fields, MD, senior vice president and head of oncology development at Bayer, said in a company-issued press release. “For [patients with indolent non-Hodgkin lymphoma] with disease progression who are in need of treatment, there are few approved treatment options. The positive results from CHRONOS-3 demonstrate the potential clinical benefit of copanlisib in combination with rituximab to address the unmet medical need in these patients.”
Complete results of CHRONOS-3 will be presented at a scientific meeting, and Bayer officials intend to discuss the findings with regulatory authorities.