Research & Development
Bayer Submits Regulatory Applications for Oncology Treatment Investigational Combination of Aliqopa (copanlisib) and Rituximab in the US and EU
21 June 2021 - - US-based Bayer has submitted a supplemental new drug application to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency seeking approval of the investigational combination of the cancer treatments Aliqopa (copanlisib) and rituximab, the company said.

The US submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin's Lymphoma and is outside of the FDA accelerated approved indication for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma, 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 annual meeting 2021, and simultaneously published in The Lancet Oncology.

Indolent NHL consists of the following subtypes: FL, MZL, small lymphocytic lymphoma and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).

The FDA has granted Orphan Drug Designations for Aliqopa in chronic lymphocytic leukemia /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).

Accelerated approval was granted for this indication based on overall response rate. 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 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.

Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is an inhibitor of phosphatidylinositol-3-kinase with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells.

Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.

Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

The clinical development program for Aliqopa also includes the Phase III study CHRONOS-4, evaluating Aliqopa in combination with standard immunochemotherapy in relapsed iNHL.


Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world.

In fiscal 2020, the Group employed around 100,000 people and had sales of EUR 41.4bn.

R and D expenses before special items amounted to EUR 4.9bn.
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