- Bayer will showcase latest data for growth driver NUBEQA® (darolutamide) and targeted radionuclide therapy XOFIGO® (radium Ra 223 dichloride)
- Bayer will also present a late-breaking abstract on the Phase I/II study of BAY 2927088 in patients with HER2-mutant non-small cell lung cancer (NSCLC), and data from VITRAKVI® in patients with tropomyosin receptor kinase (TRK) fusion lung cancer
Abstracts: 5022, 5083, TPS5122, TPS5127, e17040, LBA8598, 8570, 6095, 3105
Reno, Nevada (UroToday.com) -- Bayer will present new data across its oncology portfolio at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, from May 31 – June 4, 2024. The breadth of new data in different tumor types underscores Bayer’s ambition to deliver innovative and effective oncological therapies in areas with the highest unmet medical needs.
Prostate cancer is a key focus for Bayer Oncology, with data to be presented on NUBEQA® (darolutamide) and XOFIGO® (radium Ra 223 dichloride) across multiple stages of the disease. NUBEQA data will include a post hoc analysis from the Phase III ARASENS trial, evaluating post-progression survival with NUBEQA and androgen-deprivation therapy (ADT) plus docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC), which will further support the established efficacy profile of NUBEQA. Additionally a follow-up analysis from the Phase III ARAMIS trial, evaluating the association between prostate-specific antigen (PSA) level and risk of radiological progression with NUBEQA and ADT in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) will also be presented.
An overview of the ongoing investigational Phase III ARASTEP trial in hormone sensitive prostate cancer patients with high-risk biochemical recurrence will also be presented. Additionally, new data from the ongoing Bayer sponsored ALADDIN study, conducted by the Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, investigating the impact of NUBEQA plus ADT and radiation therapy on failure-free survival in patients with newly diagnosed prostate cancer and pelvic lymph nodes metastases 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).
In the field of targeted radionuclide therapies, Bayer will present data from the Phase III REASSURE study, evaluating patient profiles and treatment outcomes in patients with metastatic castration resistant prostate cancer (mCRPC) with XOFIGO in the real-world setting, will be shared. XOFIGO is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease.
Bayer will present a late-breaking abstract on BAY 2927088 in patients with HER2-mutant non-small cell lung cancer (NSCLC) from the Phase I/II SOHO-01 trial. BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor being investigated for patients with NSCLC harboring HER2 activating mutations.
Bayer will highlight long-term efficacy and safety data from the VICTORIA study for VITRAKVI®, including outcomes in patients with tropomyosin receptor kinase (TRK) fusion cancer treated with VITRAKVI in clinical trials (NCT02122913, NCT02576431, NCT02637687). 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.
Details on selected abstracts from Bayer at the 2024 ASCO Annual Meeting are listed below:
Darolutamide
- Abstract title: Association between prostate-specific antigen (PSA) level <0.2 ng/mL and risk of radiological progression in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC): Follow-up analysis of ARAMIS
- Poster: 5022; June 2, 2024. 09:00 AM – 12:00 PM CDT
- Abstract title: Post-progression survival of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide or placebo: Post hoc analysis of ARASENS
- Poster: 5083; June 2, 2024. 09:00 AM – 12:00 PM CDT
- 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
- TiP Poster: TPS5122; June 2, 2024. 09:00 AM – 12:00 PM CDT
- Abstract title: ALADDIN: Evaluation of darolutamide in addition to androgen deprivation therapy and radiation therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases
- TiP Poster: TPS5127; June 2, 2024. 9:00AM CDT
Radium-223 dichloride
- Abstract title: Comparing patient profiles and treatment outcomes with radium-223 (223Ra) in real-world settings: Academic vs. community practice in the US—Insights from the REASSURE study
- ePoster: e17040; Published J Clin Oncol 42, 2024, suppl 16