In addition to a combined — or objective — response rate of 59 percent, another indicator of copanlisib’s effectiveness was a median duration of response of 98 weeks, or almost two years, according to its developer, Bayer.
Data on the CHRONOS-1 trial, which covered relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) patients, was presented this week at the American Association for Cancer Research (AACR) 2017 Annual Meeting,in Washington.
“NHL is the tenth most common cancer worldwide and one of the most common cancers in the U.S. Despite treatment advances, most indolent NHL patients relapse after, or are refractory to, current therapies,” Robert LaCaze, executive vice president of Bayer, said in a press release. “The positive results from CHRONOS-1 are an important milestone and reflect the potential clinical utility of copanlisib in addressing the unmet medical need in patients with malignant lymphoma.”
CHRONOS-1 (NCT01660451) is a two-part, open-label, single-arm trial assessing the safety and effectiveness of copanlisib, a PI3K inhibitor, in 142 patients with relapsed or refractory iNHL. One hundred four of the patients had follicular lymphoma and had received at least two previous lines of therapy.
At the time researchers analyzed the trial results, 46 patients were still receiving copanlisib. The median length of treatment was 22 weeks.
Almost 59 percent of relapsed or refractory follicular lymphoma patients achieved either a full or partial response to copanlisib, with 14.4 percent having complete responses. The median duration of response was 52 weeks.
Most treatment-related adverse events were not severe and were temporary.
“Based on the National Comprehensive Cancer Network (NCCN) guidelines, inhibition of the PI3K pathway has been shown to be a promising therapeutic pathway in treating indolent lymphomas, like follicular lymphoma,” said Martin Dreyling, a professor at the University of Munich Hospital in Grosshadern.
The findings have prompted Bayer to seek accelerated U.S. Food and Drug Administration approval of copanlisib for relapsed or refractory follicular lymphoma patients with at least two previous lines of treatment.
The drug has already received orphan drug and fast track designations. They will make it easier for Bayer to continue developing it, and accelerate regulators’ review of it.