Headquarters of Bayer’s division Pharmaceuticals in Berlin, Germany. Credit: Bayer AG.

Bayer has reported that the Phase III CHRONOS-3 trial of Aliqopa (copanlisib) in combination with rituximab to treat patients with relapsed indolent Non-Hodgkin’s Lymphoma (iNHL) met its primary endpoint of prolonged progression-free survival (PFS).

Aliqopa is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor that can potentially induce tumour cell death by apoptosis and inhibition of proliferation of primary malignant B-cell lines.

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The randomised, double-blind, placebo-controlled CHRONOS-3 trial analysed whether Aliqopa plus rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL.

For the study, Bayer enrolled 458 patients who relapsed after receiving rituximab-contained therapy and either had a treatment-free interval of over 12 months after completion of the last rituximab-containing treatment or are unwilling / not allowed to undergo chemotherapy.

The trial recruited patients with follicular lymphoma (FL), small lymphocytic lymphoma (SLL), lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM), and marginal zone lymphoma (MZL).

Its safety profiles were consistent with previous data on the individual components of the combination, with no new safety signals noted.

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Based on Phase II CHRONOS-1 trial in 142 subjects, Aliqopa received accelerated approval for the treatment of adults with relapsed FL following at least two prior systemic therapies.

Continued approval will depend upon verification and description of clinical benefit in a confirmatory trial.

Bayer senior vice-president and Oncology Development head Dr Scott Fields said: “Indolent forms of Non-Hodgkin’s Lymphoma are a heterogeneous group of malignancies characterised by a chronic pattern of remissions and recurrences.

“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.”

Last month, Bayer reported data from Phase IV REPLACE trial of Adempas (riociguat) showing clinical improvement in adults suffering from pulmonary arterial hypertension (PAH).