Bayer Demonstrates Commitment to Advancing Oncology by Showcasing New Data From Innovative Science at ESMO Congress 2022

Reno, Nevada (UroToday.com) -- 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 NUBEQA^® (darolutamide) will be presented on quality of life and patient-relevant endpoints in metastatic hormone-sensitive prostate cancer (mHSPC) patients. NUBEQA is an androgen receptor inhibitor (ARi) indicated in the U.S. for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC).¹ Bayer recently received U.S. Food and Drug Administration (FDA) approval for NUBEQA in combination with docetaxel in mHSPC.

Additionally, data from the RALU study with Xofigo^® (radium Ra 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 Xofigo. These data also include 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 Xofigo. Xofigo is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease.²

On the precision oncology front, data from Vitrakvi^® (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. Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Patients should be selected for therapy based on a FDA-approved test. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.³

Other investigational data highlighting Stivarga^® (regorafenib) in recurrent or metastatic solid tumors and in relapsed/refractory metastatic colorectal cancer (mCRC) will also be presented at the congress.

Details on notable presentations from Bayer for the ESMO Congress 2022 are listed below:

Darolutamide

• Abstract title: Quality of life and patient-relevant endpoints with darolutamide in the phase 3 ARASENS study
  • Oral Presentation: 1360MO; September 11

Radium-223 dichloride (Ra-223)

• Abstract title: Lutetium-177-Prostate-Specific Membrane Antigen therapy (¹⁷⁷Lu-PSMA) in Patients (Pts) with Prior Radium-223 (223Ra): Safety and Effectiveness Outcomes
  • E-Poster: 1392P; September 11
• Abstract title: Alkaline Phosphatase (ALP) Decline and Pain Response as Markers for Overall Survival (OS) in Patients (Pts) with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Radium-223 (223Ra) in the REASSURE Study
  • E-Poster: 1394P; September 11

References:

1. NUBEQA^® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022.
2. XOFIGO^® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019.
3. Vitrakvi^® [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; March 2021.