Chronos-3 trial results : Aliqopa, rituximab combo meets primary endpoint of PFS, says Bayer

Chronos-3 trial results : Bayer said that the investigational combination of Aliqopa (copanlisib) and rituximab considerably increased progression-free survival (PFS) in patients having relapsed indolent non-Hodgkin’s Lymphoma (iNHL) in the phase 3 CHRONOS-3 clinical trial.

The late-stage trial, which featured 458 patients, compared the Aliqopa, rituximab combo in comparison to the combination of rituximab and placebo.

The patients involved in the CHRONOS-3 trial had at least one prior rituximab-containing therapy.

After a median follow-up of 19.2 months, patients who were administered the investigational combination had a median PFS of 21.5 months, in comparison to 13.8 months in patients subjected to the rituximab and placebo combo.

Bayer said that no new safety signals were noted for Aliqopa in the combination arm of the CHRONOS-3 clinical trial.

PFS is the primary endpoint of the CHRONOS-3 study.

Chronos-3 trial results : Aliqopa, rituximab combo meets primary endpoint of PFS, says Bayer. Photo courtesy of Bayer AG.

Aliqopa was approved in the US in 2017 for the treatment of relapsed follicular lymphoma (FL) in adult patients who were given at least two prior systemic therapies based on the results of the single-arm, multicenter phase 2 CHRONOS-1 clinical trial. Accelerated approval of the intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor for this indication was given on the basis of overall response rate (ORR) with continued approval to be subject to verification and description of clinical benefit in a confirmatory clinical trial.

Scott Z. Fields – Senior Vice President and Head of Oncology Development at Bayer, commenting on the Chronos-3 trial results, said: “Bayer is committed to putting patients’ needs first and delivering innovative treatment options that address areas of high unmet need, and clinical research is the first step in that process.

“These data highlight the potential of Aliqopa and rituximab as a new strategy for treating these patients and we look forward to advancing regulatory discussions.”