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Tuesday - May 11, 2021
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Bayer presents expanded research and new approaches to advance cancer care at 2021 ASCO Annual Meeting

Updated long-term efficacy and safety data of larotrectinib (Vitrakvi™) for patients with TRK fusion cancer from an integrated dataset, sub-analyses for TRK fusion cancer patients with primary central nervous system (CNS) tumors and lung cancer, respectively, as well as updated results from an intra-patient comparison to be featured / In prostate cancer, a key therapeutic area for Bayer, the safety of the Targeted Alpha Therapy radium-223 dichloride (Xofigo™) in combination with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) will be highlighted with data from the ongoing PEACE-III study; additional early-stage results in different tumor types to be presented / Additional research to highlight tolerability of darolutamide (Nubeqa™) from extended follow-up in the Phase III ARAMIS trial in non-metastatic castration-resistant prostate cancer (nmCRPC) as well as data from the ODENZA trial exploring patient preferences between darolutamide and enzalutamide in men with mCRPC / Data across other disease states on Bayer’s growing oncology portfolio with copanlisib, regorafenib and sorafenib will also be presented

Abstracts: 3108, 2002, 9109, 3114, 5079, 5046, 5002, 5036, TPS5093, TPS5091, TPS5493, 7510, 4078, 3560, 3030

Berlin, May 11, 2021 – Bayer will present new oncology data across its approved and investigational treatments at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021. Bayer’s overall presence at the meeting underscores the company’s commitment to ongoing research that maximizes the utility of existing treatments and development of new, innovative therapies to broaden the impact on patients in need.

Updated long-term efficacy and safety findings of Bayer’s precision oncology treatment larotrectinib (Vitrakvi™) for patients with TRK fusion cancer from an integrated dataset, sub-analyses for TRK fusion cancer patients with primary central nervous system (CNS) tumors and lung cancer respectively, as well as updated results from an intra-patient comparison from larotrectinib clinical trials will be shared. These data build upon the existing, robust clinical profile for Vitrakvi in patients with NTRK gene fusions. Vitrakvi, the first-ever treatment to receive a tumor-agnostic indication at the initial new drug application (NDA) in the U.S. and European Union (EU), is approved in more than 40 countries, including most recently in Japan for adult and pediatric patients with TRK fusion cancer. Additional filings in other regions are underway or planned.

New extended follow-up data on tolerability and treatment response from the Phase III ARAMIS trial of darolutamide (Nubeqa™) in non-metastatic castration-resistant prostate cancer (nmCRPC) and an exploration of patient preferences between darolutamide and enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC) will also be presented. The data from the extended follow-up analysis add to the established clinical profile for Nubeqa in patients with nmCRPC, with significant improvements in overall survival (OS) and metastasis-free survival (MFS), and a favorable safety profile over a prolonged treatment period comparable to androgen deprivation therapy (ADT) alone. The product is approved in several markets around the world, including the U.S., EU, Japan and China, for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease. Filings in other regions are underway or planned. The product is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Additional research highlighting Bayer’s radium-223 dichloride (Xofigo™), the first ever approved Targeted Alpha Therapy, will also be showcased as presentations for three ongoing Phase III/IV trials, including an oral presentation from the ongoing PEACE-III study, where Xofigo is being investigated in combination with enzalutamide. Xofigo is approved in more than 50 countries, including the U.S., EU, China and Japan for patients with mCRPC, symptomatic bone metastases and no known visceral metastases.

Subset data from the Phase III trial CHRONOS-3 evaluating copanlisib plus rituximab compared to rituximab and placebo in relapsed follicular lymphoma (FL) or marginal zone lymphoma (MZL) will analyze the potential of the combination therapy across different types of relapsed indolent non-Hodgkin’s Lymphoma (iNHL). Results from CHRONOS-3 recently published in The Lancet Oncology have shown a significant progression-free survival (PFS) benefit in patients with relapsed iNHL across all pre-specified subgroups. Copanlisib, the only pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor, is currently approved in the U.S., Israel and Taiwan under the brand name Aliqopa™ for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Approvals were based on the overall response rate (ORR) 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. The compound has also received a breakthrough therapy designation in the U.S. and China for marginal MZL based on clinical data of MZL patients enrolled in the CHRONOS-1 study. Bayer is in discussions with health authorities worldwide regarding data from CHRONOS-3.

Data from regorafenib and sorafenib will explore new treatment approaches in several difficult-to-treat tumors, potentially expanding the use of these treatments in broader patient populations. Regorafenib is approved under the brand name Stivarga™ in more than 100 countries for certain types of colorectal cancer, gastrointestinal stromal tumors and liver cancer, as well as sorafenib, which is approved under the brand name Nexavar™ for certain types of kidney, thyroid and liver cancer.

Notable presentations from Bayer projects for the 2021 ASCO Annual Meeting are listed below:

Larotrectinib

Long-term efficacy and safety of larotrectinib in an integrated dataset of patients with TRK fusion cancer
o Abstract 3108; June 4, 9:00am EDT
Efficacy and safety of larotrectinib in adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion-positive primary central nervous system tumors
o Abstract 2002; June 7, 8:00am EDT
Long-term efficacy and safety of larotrectinib in patients with TRK fusion lung cancer
o Abstract 9109; June 4, 9:00am EDT
Intra-patient comparison from larotrectinib clinical trials in TRK fusion cancer: An expanded dataset
o Abstract 3114; June 4, 9:00am EDT

Darolutamide

Darolutamide (DARO) tolerability from extended follow up and treatment response in the Phase 3 ARAMIS trial
o Abstract 5079; June 4, 9:00am EDT
ODENZA: A French prospective, randomized, open-label, multicenter, cross-over phase II trial of preference between darolutamide and enzalutamide in men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (CRPC) – Investigator-Initiated Research (IIR)
o Abstract 5046; June 4, 9:00am EDT

Radium-223 dichloride (Ra-223)

Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACEIII trial combining Ra223 with enzalutamide versus enzalutamide alone: An updated safety analysis – Investigator-Initiated Research (IIR)
o Abstract 5002; June 8, 8:00am EDT
Biomarker analysis of phase (Ph) IB trial of radium-223 (Rad) and niraparib (Nira) in patients (Pts) with metastatic castrate-resistant prostate cancer (mCRPC)(NiraRad) – Investigator-Initiated Research (IIR)
o Abstract 5036; June 4, 9:00am EDT
Radium-223 (Ra-223) versus novel antihormone therapy (NAH) for progressive metastatic castration-resistant prostate cancer (mCRPC) after 1 line of NAH: RADIANT, an international phase 4, randomized, open-label study (Trial in Progress, TiP)
o Abstract TPS5093; June 4, 9:00am EDT
A phase III trial of docetaxel versus docetaxel and radium-223 (Ra-223) in patients with metastatic castration-resistant prostate cancer (mCRPC): DORA (TiP) – Investigator-Initiated Research (IIR)
o Abstract TPS5091; June 4, 9:00am EDT
A randomized trial of radium-223 dichloride and cabozantinib in patients (pts) with advanced renal cell carcinoma (RCC) with bone metastases (RADICAL/Alliance A031801) (TiP) – Investigator-Initiated Research (IIR)
o Abstract TPS4593; June 4, 9:00am EDT

Copanlisib

Copanlisib + rituximab versus rituximab + placebo in patients with relapsed follicular (FL) or marginal zone lymphoma (MZL): Subset analysis from the phase III CHRONOS-3 trial
o Abstract 7510; June 4, 9:00am EDT

Regorafenib

Updated results of a phase 1b study of regorafenib (REG) 80 mg/day or 120 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC)
o Abstract 4078; June 4, 9:00am EDT
Single-arm, phase 2 study of regorafenib plus nivolumab in patients with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC)
o Abstract 3560; June 4, 9:00am EDT

Sorafenib

Genetic predictor of severe sorafenib-induced diarrhea and hand-foot syndrome (HFS)
o Abstract 3030; June 4, 9:00am EDT

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.

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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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Malena Johannes

Oncology
Phone +49 30 468-14079

Anna Koch

Oncology
Phone +49 30 468-15942
Phone +49 214 30-72704