Bayer shares new oncology data at 2024 ASCO Meeting

Bayer is set to present a significant tranche of new data across its oncology portfolio at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled to be held in Chicago from May 31 to June 4, 2024. The diverse array of data across multiple tumor types underscores Bayer's commitment to delivering innovative and effective cancer therapies, focusing on areas with the highest unmet medical needs.

Prostate cancer remains a central focus for Bayer Oncology. Bayer will present data on NUBEQA® (darolutamide) and XOFIGO® (radium Ra 223 dichloride) across various stages of the disease. The data for NUBEQA will include a post hoc analysis from the Phase III ARASENS trial, which evaluates post-progression survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with NUBEQA and androgen-deprivation therapy (ADT) plus docetaxel. This analysis is expected to bolster the already established efficacy of NUBEQA. Additionally, a follow-up analysis from the Phase III ARAMIS trial will be presented, examining the association between prostate-specific antigen (PSA) levels and the risk of radiological progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with NUBEQA and ADT.

An overview of the Phase III ARASTEP trial, focused on hormone-sensitive prostate cancer patients with high-risk biochemical recurrence, will also be discussed. Furthermore, new data from the ongoing ALADDIN study, which investigates the effects of NUBEQA combined with ADT and radiation therapy on failure-free survival in patients with newly diagnosed prostate cancer and pelvic lymph node metastases, will be presented.

NUBEQA is currently approved in the U.S. in combination with docetaxel for treating adult patients with mHSPC and for treating patients with nmCRPC.

In the realm of targeted radionuclide therapies, Bayer will present findings from the Phase III REASSURE study, which evaluates patient profiles and treatment outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with XOFIGO in real-world settings. XOFIGO is approved for treating patients with mCRPC who have symptomatic bone metastases and no known visceral metastatic disease.

Bayer will also unveil a late-breaking abstract on BAY 2927088 from the Phase I/II SOHO-01 trial in patients with HER2-mutant non-small cell lung cancer (NSCLC). BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor being investigated for efficacy in NSCLC patients with HER2 activating mutations.

Additionally, Bayer will highlight long-term efficacy and safety data from the VICTORIA study for VITRAKVI® (larotrectinib). This includes outcomes in patients with tropomyosin receptor kinase (TRK) fusion cancer treated with VITRAKVI in clinical trials. VITRAKVI is approved for treating adult and pediatric patients with solid tumors that have an NTRK gene fusion, are metastatic, or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. This indication was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval may depend on verification and description of clinical benefit in confirmatory trials.

The abstracts from Bayer at the 2024 ASCO Annual Meeting will include:
- Darolutamide: Poster presentations on the association between PSA levels and radiological progression in nmCRPC patients, post-progression survival in mHSPC patients, and other trials including ARASTEP and ALADDIN.
- Radium-223 dichloride: Insights from the REASSURE study comparing patient profiles and treatment outcomes in real-world settings.
- BAY 2927088: A late-breaking abstract presenting safety and clinical activity in HER2-mutant NSCLC patients.
- Larotrectinib: Multiple abstracts detailing long-term efficacy and safety in patients with TRK fusion lung cancer, TRK fusion thyroid carcinoma, and outcomes compared with non-TRK inhibitor therapies.

Bayer’s oncology portfolio, including NUBEQA, XOFIGO, and VITRAKVI, reflects the company's dedication to advancing cancer treatment through innovation and addressing high unmet medical needs.