Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for copanlisib (Aliqopa™) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin's Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin's Lymphoma in the U.S. The Breakthrough Therapy Designation was based on data from the MZL subgroup of the pivotal Phase II trial CHRONOS-1 that led to accelerated approval of copanlisib in the U.S. for the treatment of adult patients with relapsed follicular lymphoma (FL, the most common histological subtype of iNHL) who have received at least two prior systemic therapies. Copanlisib is a pan-class intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The compound is currently not approved by the European Medicines Agency (EMA) or other authorities outside of the U.S.

"The clinical evidence suggests that copanlisib may address an unmet medical need by providing physicians and MZL patients with a therapy in a relapsed setting where there are no approved treatments," said Dr. Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer's Pharmaceutical Division. "We will continue working closely with the FDA in order to bring copanlisib to these underserved patients as soon as possible."

The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of drug candidates that treat serious or life-threatening diseases or conditions, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

Bayer is conducting two additional Phase III studies - CHRONOS-3 and CHRONOS-4 - to evaluate the efficacy and safety of copanlisib in combination with other therapies in iNHL (including MZL) patients who have relapsed following one or more prior therapies.

Clinical evidence for copanlisib in MZL

In the Phase II study 16439 part B (CHRONOS-1), copanlisib was investigated in iNHL patients including 23 patients with relapsed or refractory MZL, who have received at least two prior therapies. An 18 month follow-up analysis of CHRONOS-1 showed an ORR in the full set analysis (FAS) population of 60.6% and in the MZL histology an ORR of 78.3% (n=23). The overall safety of copanlisib confirmed the expected tolerability and manageable safety profile.

About marginal zone lymphoma (MZL)

MZL is an indolent form of non-Hodgkin's Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin’s Lymphoma in the U.S. Typically chemotherapy and/or immunotherapy are often chosen for the treatment of MZL. While initial therapies are often successful, there continues to be an unmet need for relapsed (advanced) MZL.

About copanlisib (Aliqopa) injection

Copanlisib is a pan-PI3K inhibitor with predominant activity against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B-cells, developed by Bayer. Copanlisib is approved in the U.S. for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

The U.S. FDA approved copanlisib under the brand name Aliqopa™, in September 2017 for the treatment of adult patients with relapsed follicular lymphoma (FL) 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. Copanlisib has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Copanlisib 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 broad clinical development program for copanlisib also includes ongoing Phase III studies in indolent NHL (iNHL) patients who have relapsed or are refractory to prior therapies. The CHRONOS-3 Phase III study is evaluating copanlisib in combination with rituximab in relapsed iNHL and the CHRONOS-4 Phase III study is evaluating copanlisib in combination with standard immunochemotherapy in relapsed iNHL. More information about these trials can be found at www.clinicaltrials.gov.

Copanlisib is currently not approved outside of the U.S.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes five marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

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 benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros.

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