Bayer is advancing in the fight against cancer showcasing new study data at ESMO Congress 2022

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Summary

In prostate cancer, a key therapeutic area for Bayer, new patient-relevant data from the ARASENS Phase III study in metastatic hormone-sensitive prostate cancer (mHSPC) will be showcased, as well as data from the RALU study comprising real-world evidence with radium-223 dichloride as a prior treatment to 177Lu-PSMA for patients with metastatic castration-resistant prostate cancer (mCRPC) / On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors (also known as TRK fusion cancers) / New data evaluating regorafenib in various cancers will also be featured

Presentations: 1360MO, 1392P, 1394P, 464P, 463P, 1209P, 400P

Berlin, August 30, 2022 – Bayer will present key scientific research in oncology at the upcoming ESMO Congress 2022 from September 9-13, 2022. Data will highlight Bayer’s commitment to advancing unmet needs in prostate cancer, providing expertise in precision medicine, and working on immunotherapy combinations, including company-sponsored and collaborative research studies.

New Phase III ARASENS trial data for darolutamide will be presented on quality of life and patient-relevant endpoints in those living with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is an androgen receptor inhibitor (ARi) approved under the brand name Nubeqa™ in more than 70 countries around the world, including the U.S., European Union (EU), Japan, and China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Bayer recently received U.S. Food and Drug Administration (FDA) approval for darolutamide in combination with docetaxel in mHSPC and submitted applications for darolutamide in combination with docetaxel in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labor, and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE). Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Additionally, data from the RALU study with radium-223 dichloride will be presented, which includes safety and effectiveness outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving lutetium-177-prostate-specific membrane antigen (¹⁷⁷Lu-PSMA) after radium-223 dichloride. This data not only focuses on the treatment sequence of radium-223 dichloride followed by ¹⁷⁷Lu-PSMA, but also includes data on the feasibility of adding docetaxel in the treatment pathway. Data from the REASSURE study will also be featured, showing the value of the biomarker alkaline phosphatase (ALP) for assessing treatment response with radium-223 dichloride. Radium-223 dichloride, approved under the brand name Xofigo™, is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.

On the precision oncology front, data from larotrectinib clinical trials in pediatric and adult patients with NTRK gene fusion-positive solid tumors will be presented, including an expanded intra-patient comparison dataset in TRK fusion cancer, and efficacy and safety data in a pooled analysis of patients with TRK fusion cancer with an extended follow-up. Larotrectinib, the first treatment to receive a tumor-agnostic indication in the EU is approved under the brand name Vitrakvi™ in more than 45 countries, including the U.S. and most recently in China for pediatric and adult patients with NTRK fusion-positive advanced or recurrent solid tumors. Additional filings in other regions are underway or planned.

Other investigational data highlighting regorafenib, approved under the brand name Stivarga™, in recurrent or metastatic solid tumors and in relapsed/refractory metastatic colorectal cancer (mCRC) will also be presented at the congress.

Details on notable presentations from Bayer for the ESMO Congress 2022 are listed below:

Darolutamide

· Quality of life and patient-relevant endpoints with darolutamide in the phase 3 ARASENS study

o Oral Presentation: 1360MO; September 11

Radium-223 dichloride (Ra-223)

· Lutetium-177-Prostate-Specific Membrane Antigen therapy (¹⁷⁷Lu-PSMA) in Patients (Pts) with Prior Radium-223 (223Ra): Safety and Effectiveness Outcomes

o E-Poster: 1392P; September 11

· Alkaline Phosphatase (ALP) Decline and Pain Response as Markers for Overall Survival (OS) in Patients (Pts) with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Radium-223 (223Ra) in the REASSURE Study

o E-Poster: 1394P; September 11

Larotrectinib

· Intra-Patient (Pt) Comparison From Larotrectinib (Laro) Clinical Trials in Tropomyosin Receptor Kinase (TRK) Fusion Cancer - an Expanded Dataset

o E-Poster: 464P; September 12

· Efficacy and Safety of Larotrectinib in a Pooled Analysis of Patients (Pts) With Tropomyosin Receptor Kinase (TRK) Fusion Cancer With an Extended Follow-Up

o E-Poster: 463P; September 12

Regorafenib

· A phase II study of regorafenib in combination with nivolumab in patients with recurrent or metastatic solid tumors: Results from the esophageal squamous cell carcinoma (ESCC) cohort

o E-Poster: 1209P; September 12

· Impact of regorafenib dose optimization on comparative outcomes in the treatment of relapsed/refractory metastatic colorectal cancer (mCRC)

o E-Poster: 400P; September 11

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. 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 the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/

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