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Monday - June 21, 2021
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Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU

In the US, Bayer has filed for relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL) / In the EU, Bayer has filed for relapsed marginal zone lymphoma (MZL), a subtype of iNHL, and the filing has been accepted / Filings based on results from Phase III trial CHRONOS-3 showing a significant improvement in the primary endpoint of progression-free survival for the combination of copanlisib and rituximab in patients with relapsed iNHL

Berlin, June 21, 2021 – Bayer today 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 novel combination of the cancer treatments copanlisib and rituximab. The U.S. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL). 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. Bayer has previously received an orphan drug designation (ODD) for MZL in the EU. 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. Indolent NHL consists of the following subtypes, follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).

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

Additionally, the FDA has granted Orphan Drug Designations (ODD) for copanlisib in CLL)/small lymphocytic lymphoma (SLL) and LPL/WM. Copanlisib has been previously granted an ODD in the U.S. for FL and MZL.

Copanlisib, the only pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor, is already approved in the U.S., Israel and Taiwan as a monotherapy under the brand name Aliqopa™ for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. These approvals are based on the results of a single-arm, multi-center, Phase II clinical trial (CHRONOS-1). In China, the filing for this indication was granted priority review. Bayer plans to seek additional filings worldwide based on the data from CHRONOS-3.

About CHRONOS-3
CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether copanlisib 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. 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 whom chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included.

Data from CHRONOS-3 showed a significant improvement in the primary endpoint of PFS with the combination of copanlisib and rituximab given intravenously compared to the combination of rituximab and placebo. The adverse event (AE) profile of the combination was generally consistent with previously published data on the individual components of the combination and no new safety signals were identified.

About non-Hodgkin’s lymphoma
Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the tenth most common cancer worldwide, with about 510,000 new cases diagnosed in 2018. It accounts for about 250,000 deaths per year worldwide.

Indolent NHL consists of multiple subtypes, including follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). While the disease is typically slow growing, it can become more aggressive over time. Despite treatment advances, there remains a need for improved and differentiated treatment options for the relapsed or refractory stage of the disease. After response to initial therapy, response rates and duration of response decline with subsequent lines of therapy, underscoring the need for patients whose disease has already progressed.

About Copanlisib (Aliqopa™)
Developed by Bayer, copanlisib is the only pan class I PI3K inhibitor with inhibitory activity against all four isoforms including the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It is also the only PI3K inhibitor administered intravenously on an intermittent schedule, allowing effective inhibition of the PI3K pathway in tumor cells while limiting toxicity to healthy cells. The PI3K pathway is involved in cell growth, survival and metabolism, and aberrant activation and is occurring across different solid and hematological tumor types, including all subtypes of iNHL. Its dysregulation plays an important role in lymphoma.

Copanlisib is currently approved in the U.S., Israel and Taiwan as a monotherapy under the brand name Aliqopa™ for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Approvals were based on an overall response rate (ORR) of 59%, including 14% of complete responses (CRs) from the open-label, single-arm Phase II CHRONOS-1 (NCT01660451) trial of copanlisib monotherapy in 104 adult patients with follicular B-cell NHL who had relapsed disease following at least two prior systemic therapies (1) Updated data for CHRONOS-1, published in the American Journal of Hematology in 2020, showed an ORR of 59% including 20% of CRs in patients with follicular B-cell NHL. (2) In China, the filing for this indication was granted priority review. The compound has also received a breakthrough therapy designation in the U.S. and China for marginal zone lymphoma (MZL) based on clinical data of MZL patients enrolled in the CHRONOS-1 study.

Bayer plans to seek additional filings worldwide based on the data from CHRONOS-3.

The clinical development program for copanlisib also includes the Phase III study CHRONOS-4, evaluating copanlisib in combination with standard immunochemotherapy in relapsed iNHL. More information about this trial can be found at www.clinicaltrials.gov.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes six marketed products across various indications and several compounds in different stages of clinical development. Bayer focuses its research activities on first-in-class innovations across the following scientific platforms: Precision Molecular Oncology, Targeted Alpha Therapies, and Immuno-Oncology. Across the areas of focus, we have several prostate cancer treatments on the market or in development, with the goal of extending survival while limiting side effects of treatment throughout the different stages of the disease. Another key focus at Bayer is on innovative precision oncology treatments, with an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread, and another TRK inhibitor advancing through the pipeline. The company’s approach to research 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 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 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

(1) ClinicalTrials.gov. Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas. Available online: https://clinicaltrials.gov/ct2/show/NCT01660451. Last Accessed: March 2021.
(2) Dreyling, M.; Santoro, A.; Mollica, L.; Leppa, S.; Follows, G.; Lenz, G.; Kim, W.S.; Nagler, A.; Dimou, M.; Demeter, J.; Ozcan, M.; Kosinova, M.; Bouabdallah, K.; Morschhauser, F.; Stevens, D.A.; Trevarthen, D.; Munoz, J.; Rodrigues, L.; Hiemeyer, F.; Miriyala, A.; Garcia-Vargas, J.; Childs, B.H.; Zinzani, P.L. Am. J. Hematol. 2020, 95, 362-371. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Anna Koch

Oncology
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