Bayer to Present New Prostate Cancer Data and Continued Oncology Portfolio Research at ESMO 2024

Reno, Nevada (UroToday.com) -- Bayer will present new oncology data, including a late-breaking, comprehensive analysis from the Phase III ARANOTE trial investigating NUBEQA^® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain, from September 13-17, 2024.

NUBEQA is indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).¹

Late-breaking results from the European Organisation for Research and Treatment of Cancer’s (EORTC) Phase III PEACE-III study of the first-and-only-approved targeted alpha emitting radiopharmaceutical, XOFIGO^® (radium-223 dichloride), in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC), of which Bayer is a key sponsor, will be presented during a Presidential Symposium.

XOFIGO injection is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.²

Bayer will also highlight an updated analysis from the SCOUT (pediatric participants) and NAVIGATE (adult and pediatric participants) studies evaluating the efficacy and safety of VITRAKVI^® (larotrectinib) in patients with TRK fusion cancer.

VITRAKVI is approved for the treatment of adult and pediatric patients with solid tumors that have an 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 an 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

Trial in Progress (TiP) data from SOHO-2, a Phase III trial evaluating the effect of oral BAY 2927088 compared with standard of care as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations, will also be presented. Late-breaking results from the Phase I/II SOHO-01 trial will be presented during a Presidential Symposium at the 2024 World Conference on Lung Cancer (WCLC 2024), taking place September 7-10, in San Diego. BAY 2927088 is an oral, reversible, small molecule tyrosine kinase inhibitor under investigational development as a potential new targeted therapy for patients with NSCLC harboring HER2-activating mutations.

Details on abstracts follow:

NUBEQA (darolutamide)

• Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARANOTE trial
  • Abstract: LBA68; September 16, 2024; 10:15 a.m. CEST/4:15 a.m. EDT

XOFIGO (Radium-223 dichloride)

• A randomized multicenter open-label phase III trial comparing enzalutamide vs. a combination of radium-223 (223Ra) and enzalutamide in asymptomatic or mildly symptomatic patients with castration-resistant prostate cancer and bone metastases. First results of EORTC-1333/PEACE III
  • Abstract: LBA1; Presidential Symposium 1; September 14, 2024; 4:30 p.m. CEST/10:30 a.m. EDT

• Lutetium-177–prostate-specific membrane antigen (177Lu-PSMA) therapy in patients with prior radium‑223 (223Ra)
  • Abstract: 1629P; September 15, 2024

• Open-label, multi-centre randomised trial of radium-223-docetaxel versus docetaxel-Radium 223 sequence in metastatic castration resistant prostate cancer (mCRPC) with prospective biomarker evaluation for patient selection (RAPSON study)
  • Abstract: LBA71; September 16, 2024; 10:50 a.m. CEST/4:50 a.m. EDT

VITRAKVI (larotrectinib)

• Efficacy and safety of larotrectinib as first-line treatment for patients with TRK fusion cancer: an updated analysis
  • Abstract: 628P; September 14, 2024

• Long-term efficacy and safety of larotrectinib in non-primary central nervous system (CNS) TRK fusion cancer
  • Abstract: 627P; September 14, 2024

BAY 2927088

• A randomized phase III trial evaluating oral BAY 2927088, compared with standard of care, as first-line treatment of locally advanced or metastatic NSCLC harboring HER2-activating mutations (SOHO-02)
  • Abstract: 1395TiP; September 14, 2024

STIVARGA (regorafenib)

• EREMISS Trial: A double-blind placebo (PBO)-controlled randomized trial assessing efficacy/safety of regorafenib (REGO) as maintenance therapy after 1st line doxorubicin-based chemotherapy in advanced soft-tissue sarcoma (ASTS) patients (pts)
  • Abstract: 1718O; September 16, 2024; 2:45 p.m. CEST/8:45 a.m. EDT
    
    
• Regomune study: A phase II study of regorafenib + avelumab in solid tumors. Results of the radioiodine-refractory differentiated thyroid cancer (RR-DTC)
  • Abstract: 1925MO; September 13, 2024; 4:00 p.m. CEST/10:00 a.m. EDT
    
    
• Artificial Intelligence (AI) based prognostication from baseline computed tomography (CT) scans in a phase 3 advanced non-small cell lung cancer (aNSCLC) trial
  • Abstract: 222P; Sunday, September 15, 2024

Source: BUSINESS WIRE. (2024). Bayer to Present New Prostate Cancer Data and Continued Oncology Portfolio Research at ESMO 2024 [Press release]. https://www.businesswire.com/news/home/20240905157527/en/Bayer-to-Present-New-Prostate-Cancer-Data-and-Continued-Oncology-Portfolio-Research-at-ESMO-2024.