17
January
2024
|
14:29 PM
Europe/Amsterdam

Bayer to showcase latest data from prostate cancer portfolio at 2024 ASCO GU Cancers Symposium

Not intended for U.S. and UK Media

Summary

Bayer continues to focus on advancing prostate cancer care, presenting additional data on darolutamide from the ARASENS trial and radium-223 dichloride from the REASSURE trial

Abstracts: 106, 166, 228, 324, TPS243, TPS254

Berlin, January 17, 2024 – Bayer will present new data from across its prostate cancer portfolio at the upcoming American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place in San Francisco, United States, from January 25-27, 2024. These presentations underscore Bayer´s commitment to advance prostate cancer care by developing therapies that delay disease progression and extend survival through different stages of the disease, while maintaining quality of life.

Darolutamide data will include post hoc sensitivity analyses from the Phase III ARASENS trial, evaluating overall survival with darolutamide and androgen-deprivation therapy (ADT) plus docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) accounting for subsequent therapy. A separate analysis from the same trial comparing hospitalization rates and length of hospital stay during and post-docetaxel will also be presented. An overview will be provided for the ongoing Phase III ARASTEP trial that is investigating whether darolutamide plus ADT improves radiological progression-free survival as assessed by prostate-specific membrane antigen positron emission tomography-computed tomography (PSMA PET-CT) versus ADT alone in hormone sensitive prostate cancer patients with high-risk biochemical recurrence, and for the Phase II ARAMON study comparing the effect of darolutamide to enzalutamide monotherapy on serum testosterone levels in patients with castration-sensitive prostate cancer after biochemical recurrence.

Furthermore, a systematic review will assess the consistency of findings from indirect treatment comparisons designed to compare efficacy and safety of treatment alternatives in mHSPC that have not been tested in head-to-head trials. Darolutamide is approved under the brand name Nubeqa™ in more than 85 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also approved for the treatment of patients with mHSPC in over 75 markets including the U.S., Japan, EU, and China.

Bayer will also present new data in the US subset of patients enrolled in the REASSURE observational study evaluating safety outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride following external beam radiation therapy. 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 more than 50 countries.

Details on selected abstracts from Bayer at the 2024 ASCO GU Cancers Symposium are listed below:

Darolutamide

·         Overall survival with darolutamide vs placebo in combination with androgen-deprivation therapy (ADT) and docetaxel: A sensitivity analysis from ARASENS accounting for subsequent therapy

o   Poster: G16; January 25, 2024. 11:30 AM – 1:00 PM PST

·         Rate of hospitalization and length of hospital stay during and post docetaxel for darolutamide in metastatic hormone-sensitive prostate cancer using ARASENS

o   Poster: K16; January 25, 2024. 11:30 AM – 1:00 PM PST

·         Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP) - Trial in Progress

o   Poster: Q15; January 25, 2024. 11:30 AM – 1:00 PM PST

·         ARAMON: a phase 2, randomized, open-label study comparing darolutamide (DARO) vs enzalutamide (ENZA) monotherapy on serum testosterone levels in patients (pts) with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR) - Trial in Progress

o   Poster: Q4; January 25, 2024. 11:30 AM – 1:00 PM PST

·         A systematic review: are the findings of indirect treatment comparisons (ITCs) in metastatic hormone-sensitive prostate cancer (mHSPC) consistent?

o   Poster: N15; January 25, 2024. 11:30 AM – 1:00 PM PST

Radium-223 dichloride

·         Safety outcomes in patients with metastatic castration-resistant prostate cancer treated with radium-223 following external beam radiation therapy: REASSURE US subset

o   Poster: D21; January 25, 2024. 11:30 AM – 1:00 PM PST

About Prostate Cancer 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 new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of prostate cancer patients, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.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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