Bayer announced results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant progression-free survival (PFS) benefit for the combination of copanlisib, the only pan class I phosphatidylinositol-3-kinase inhibitor, and rituximab in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL).
The study that enrolled 458 patients showed that patients treated with this combination had a decrease in risk of disease progression or death by 48% compared to patients treated with placebo and rituximab, with a median PFS of 21.5 months versus 13.8 months, Bayer said in its press release.
The company further explained that the strong reduction in risk of progression or death was observed across all prespecified iNHL subtypes including follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia.
Copanlisib is already approved as a monotherapy in the U.S. under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial, Bayer said.
“Copanlisib is the first PI3K inhibitor to demonstrate broad and superior efficacy in combination with rituximab with a manageable safety profile in patients with relapsed iNHL across all pre-specified subtypes compared to rituximab and placebo,” said Dr. Scott Z. Fields, Senior Vice President and Head of Oncology Development at Bayer. “In addition to the superior efficacy observed in CHRONOS-3, treatment-limiting side effects commonly associated with existing oral PI3K inhibitors, such as severe gastrointestinal toxicities and immune-mediated events, are infrequent with the combination of copanlisib and rituximab.”
Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the tenth most common cancer worldwide. It accounts for about 250,000 deaths per year worldwide.