German chemical and lifesciences firm Bayer has reported positive results from the Phase II CHRONOS-1 clinical trial of copanlisib for the treatment of indolent non-Hodgkin's lymphoma (iNHL) patients.
Copanlisib is an investigational intravenous pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor, which has predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.
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The company noted that the primary endpoint of a pre-specified objective response rate (ORR) was met in the trial.
The open-label, single-arm Phase II trial investigated the efficacy and safety of the product in 142 patients with relapsed or refractory iNHL, including follicular lymphoma (FL) who received a minimum of two prior therapies.
Bayer oncology strategic business unit executive vice-president and head Robert LaCaze said: "NHL is the tenth most common cancer worldwide and one of the most common cancers in the US.
"Despite treatment advances, most indolent NHL patients relapse after, or are refractory to, current therapies.
"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."
While the trial's primary endpoint was objective tumour response rate, the secondary endpoints included duration of response, overall survival, progression-free survival, quality of life and safety.
The US Food and Drug Administration (FDA) has granted fast-track designation for copanlisib in relapsed or refractory FL, as well as orphan drug designation (ODD) to treat FL.
The product has also obtained ODD for the treatment of patients with splenic, nodal, and extranodal subtypes of marginal zone lymphoma (MZL).
