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 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 [(14)C] Darolutamide Compared with
[(14)C] 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 ×
10(9)/L, the platelet count greater than or equal to 100 × 10(9)/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 × 10(9)/L
and the platelet count greater than or equal to 50 × 10(9)/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
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