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.