- Continuing its focus on progressing prostate cancer care, Bayer will present additional data on NUBEQA® (darolutamide) from the Phase III ARASENS trial in metastatic hormone-sensitive prostate cancer (mHSPC), and U.S. subset data from the observational REASSURE trial examining XOFIGO® (radium Ra 223 dichloride) after external beam radiation therapy (EBRT) in metastatic castration-resistant prostate cancer (mCRPC)
Abstracts: 166, 228, TPS254, TPS243, 324, 106
Reno, Nevada (UroToday.com) -- Bayer will present new data across its prostate cancer portfolio at the upcoming American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place January 25-27, 2024 in San Francisco, California. These presentations underscore Bayer’s commitment to advance prostate cancer care.
NUBEQA® (darolutamide) data includes post hoc sensitivity analyses from the Phase III ARASENS trial, evaluating overall survival (OS) with NUBEQA and androgen deprivation therapy (ADT) and docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC) patients 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 update will be provided from ARASTEP, the ongoing Phase III trial investigating NUBEQA plus ADT versus ADT alone in hormone-sensitive patients with high-risk biochemical recurrence (BCR), and ARAMON, the ongoing Phase II randomized, open-label investigational study comparing NUBEQA to enzalutamide monotherapy on serum testosterone levels in patients with castration-sensitive prostate cancer (CSPC) after BCR. Furthermore, a systematic review on indirect treatment comparisons in mHSPC will be presented.
NUBEQA is currently indicated in the U.S. in combination with docetaxel for the treatment of adult patients with mHSPC and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1
Bayer will also present new data from the REASSURE observational study evaluating the safety outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with XOFIGO® (radium Ra 223 dichloride) following EBRT in the U.S. subset of patients enrolled.
XOFIGO is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease.2
Details on select abstracts from Bayer at the 2024 ASCO GU Cancers Symposium are listed below:
Darolutamide
- Abstract title: Overall survival with darolutamide vs placebo in combination with androgen-deprivation therapy (ADT) and docetaxel: A sensitivity analysis from ARASENS accounting for subsequent therapy
- Poster: G16; January 25, 11:30AM-1:00PM PST
- Abstract title: Rate of hospitalization and length of hospital stay during and post docetaxel for darolutamide in metastatic hormone-sensitive prostate cancer using ARASENS
- Poster: K16; January 25, 11:30AM-1:00PM PST
- Abstract title: 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
- Poster: Q15; January 25, 11:30AM-1:00PM PST
- Abstract title: 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
- Poster: Q4; January 25, 11:30AM-1:00PM PST
- Abstract title: A systematic review: Are the findings of indirect treatment comparisons (ITCs) in metastatic hormone-sensitive prostate cancer (mHSPC) consistent?
- Poster: N15; January 25, 11:30AM-1:00PM PST
Radium-223 dichloride (Ra-223)
- Abstract title: Safety outcomes in patients with metastatic castration-resistant prostate cancer treated with radium-223 following external beam radiation therapy: REASSURE US subset
- Poster: D21; January 25, 11:30AM-1:00PM PST