In the U.S., Bayer has filed for relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL)

In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted

Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational combination of the cancer treatments Aliqopa® (copanlisib) and rituximab. The U.S. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s Lymphoma (iNHL) and is outside of the FDA accelerated approved indication for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted. The submissions are supported by positive results from the Phase III trial CHRONOS-3, which were presented in April at the American Association for Cancer Research (AACR) Annual Meeting 2021, and simultaneously published in The Lancet Oncology.1 Indolent NHL consists of the following subtypes: FL, MZL, small lymphocytic lymphoma (SLL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).

“The U.S. and EU submissions of the novel combination of Aliqopa and rituximab bring us forward in advancing new treatment approaches and addressing unmet needs of patients with different types of relapsed iNHL,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “We are excited about the potential of this investigational combination therapy based on the findings from CHRONOS-3 and we look forward to working with global regulatory authorities.”

The FDA has granted Orphan Drug Designations (ODD) for Aliqopa in chronic lymphocytic leukemia (CLL)/SLL and LPL/WM, and has previously granted an ODD for Aliqopa in FL and MZL. Additionally, Aliqopa was granted Breakthrough Therapy Designation for relapsed MZL in patients who have received at least two prior therapies. Bayer has also previously received an ODD for MZL in the EU.

In 2017, Aliqopa was approved for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies based on the results of a single-arm, multi-center, Phase II clinical trial (CHRONOS-1).2 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending progression-free survival (PFS) in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Histological subtypes included in the trial were FL, SLL, LPL/WM, and MZL. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included (NCT02367040). The study enrolled 458 participants.