For Immediate Release

Bayer to Feature Prostate Cancer Research at ASCO GU 2018 Symposium

WHIPPANY, N.J., Feb. 7, 2018 /PRNewswire/ -- Bayer announced today that research on Xofigo® (radium Ra 223 dichloride) injection and darolutamide, the company's investigational oral androgen receptor (AR) antagonist, in prostate cancer will be presented at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 8-10 in San Francisco.

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. (PRNewsfoto/Bayer Corporation)

Bayer will present data from the first interim analysis of REASSURE, a real-world, observational study to assess the safety of radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC) in the U.S. In addition, efficacy and safety data from an international, open-label study in mCRPC patients who were re-treated with radium-223 will be presented. Bayer will also present on darolutamide, including the ARASENS pivotal trial in men with metastatic hormone-sensitive prostate cancer (mHSPC).

"We look forward to presenting analyses on the long-term efficacy and safety of radium-223 and data on our investigational compound darolutamide at this year's ASCO GU Symposium," said Scott Fields, MD, Bayer's senior vice president and head of Pharmaceutical Development, Oncology. "We are committed to the prostate cancer community and to Bayer's critical mission of serving those patients with the greatest unmet needs."

Notable radium-223 and darolutamide studies to be presented at the ASCO GU 2018 Symposium include the following:

Radium-223 Dichloride (radium-223)

  • Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up
    • Abstract 178, BOARD H18, Poster Session A: Prostate Cancer and Trials in Progress
    • Date: Thursday, February 8: 11:30 AM-1:00 PM and 5:15 PM-6:15 PM
    • Location: Level 1, West Hall
  • First interim results of the Radium-223 (Ra-223) reassure observational study in metastatic castration-resistant prostate cancer (mCRPC): Safety and baseline (BL) characteristics of U.S. patients (Pts) by prior/concomitant treatment (Tx)
    • Abstract 233, BOARD L9, Poster Session A: Prostate Cancer and Trials in Progress
    • Date: Thursday, February 8: 11:30 AM-1:00 PM and 5:15 PM-6:15 PM
    • Location: Level 1, West Hall

Darolutamide

  • ARASENS: A phase 3 trial of darolutamide in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer (mHSPC)
    • Abstract TPS383, BOARD P1, Poster Session A: Prostate Cancer and Trials in Progress
    • Date: Thursday, February 8: 11:30 AM-1:00 PM and 5:15 PM-6:15 PM
    • Location: Level 1, West Hall
  • Blood Brain Barrier Penetration of [14C] Darolutamide Compared with [14C] Enzalutamide in Rats Using Whole Body Autoradiography
    • Abstract 345, BOARD D14, Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers and Trials in Progress
    • Date: Friday, February 9: 12:15 PM-1:45 PM and 6:00 PM-7:00 PM
    • Location: Level 1, West Hall

General Castration-resistant Prostate Cancer (CRPC)

  • Survival outcomes of pre-metastatic castration-resistant prostate cancer and the burden of developing metastasis: A systematic literature review
    • Abstract 293, BOARD B4, Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers and Trials in Progress
    • Date: Friday, February 9: 12:15 PM-1:45 PM and 6:00 PM-7:00 PM
    • Location: Level 1, West Hall

About Xofigo® (radium Ra 223 dichloride) Injection  
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.1

Important Safety Information for Xofigo® (radium Ra 223 dichloride) Injection

  • Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.
  • Bone Marrow Suppression: In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression – notably thrombocytopenia, neutropenia, pancytopenia, and leucopenia – has been reported in patients treated with Xofigo.
    Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.
  • Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than or equal to 1.5 × 109/L, the platelet count greater than or equal to 100 × 109/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 109/L and the platelet count greater than or equal to 50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.
  • Concomitant Use with Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.
  • Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.
  • Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia.
  • Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo.
  • Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium -223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow up for patients on the trial.
  • Subsequent Treatment with Cytotoxic Chemotherapy: In the randomized clinical trial, 16% patients in the Xofigo group and 18% patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy.
  • Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).

For full Prescribing Information visit http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf.

About Darolutamide 
Darolutamide is an investigational oral androgen receptor (AR) antagonist that is thought to block the growth of cancer cells by binding to the AR and inhibiting the receptor function. In preclinical studies, darolutamide and its main circulating metabolite were also active in known AR mutations, such as W742L and F877L.

Darolutamide is currently in Phase III clinical trials for the treatment of patients with castration-resistant prostate cancer (CRPC). It is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

About Oncology at Bayer 
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes four oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life 
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

© 2018 Bayer
BAYER, the Bayer Cross, and Xofigo are registered trademarks of Bayer.

Media Contact:
Rose Talarico, Tel. +1 862.404.5302 
E-Mail: rose.talarico@bayer.com

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.

1. XOFIGO® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, February 2018.

Abstracts: 178, 233, TPS383, 345, 293

Intended for U.S. Media Only

PP-600-US-3380

SOURCE Bayer