- Bayer will present late-breaking data from its oncology portfolio, including results from the Phase III ARANOTE trial on darolutamide in metastatic hormone-sensitive prostate cancer (mHSPC) and from the PEACE-III study on radium-223 dichloride in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC).
- New data on larotrectinib for TRK fusion cancer and updates on BAY 2927088 for HER2-positive non-small cell lung cancer (NSCLC) will be showcased, reflecting Bayer’s commitment to advancing treatments for difficult-to-treat cancers.
- Darolutamide and radium-223 dichloride will be key highlights in Bayer’s ongoing efforts to improve treatment options for patients with prostate cancer, offering personalized approaches to extend survival and delay disease progression.
- Bayer’s oncology data, with approvals in over 80 countries for some therapies, demonstrates the company’s global reach in delivering life-extending cancer treatments.
Oncology remains a critical focus for Bayer as the company prepares to present late-breaking data from its diverse oncology portfolio at the European Society for Medical Oncology (ESMO) Congress in September 2024. Bayer’s commitment to advancing treatments for difficult-to-treat cancers will be showcased through key presentations, particularly in the fields of prostate cancer, lung cancer, and TRK fusion-positive cancers. These new data and updates underscore Bayer’s dedication to bringing innovative therapies to patients worldwide, tailored to individual disease presentations.
At the forefront of Bayer’s presentations is the ARANOTE trial, a Phase III study investigating the combination of darolutamide and androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, already approved under the brand name Nubeqa® in over 80 markets, including the U.S., Japan, the EU, and China, is designed to extend survival and delay disease progression in mHSPC. The ARANOTE trial aims to provide further evidence of its efficacy in this patient population, potentially offering new insights into how darolutamide can be combined with existing therapies to improve patient outcomes. The results of this trial will be presented in an oral session, marking an important milestone in the development of darolutamide as a key treatment option for prostate cancer.
Oncology Breakthrough: Bayer to Present PEACE-III Study Results on Radium-223 and Enzalutamide Combination for mCRPC at ESMO 2024
Additionally, Bayer will reveal late-breaking data from the PEACE-III study, which explores the use of radium-223 dichloride in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). This study, supported by Bayer, evaluates the benefits of adding radium-223 dichloride—a targeted alpha therapy that has already been approved in more than 50 countries under the brand name Xofigo®—to enzalutamide treatment. The trial focuses on patients with asymptomatic or mildly symptomatic mCRPC and aims to determine whether this combination can further delay disease progression and improve survival.
The findings will be presented during the “Presidential Symposium I: Practice-changing trials” at the ESMO congress. In addition to prostate cancer, Bayer will also present new data on larotrectinib, marketed as Vitrakvi®, which has been approved in more than 45 countries for pediatric and adult patients with TRK fusion-positive solid tumors. Updated analyses from the SCOUT and NAVIGATE studies will be discussed, evaluating the efficacy and safety of larotrectinib as a first-line treatment for patients with TRK fusion cancers.
TRK fusion cancers are rare but aggressive, and larotrectinib has shown promise in providing targeted therapy to these patients, offering a more personalized approach to treatment. The data presented at ESMO will further highlight its role in treating these cancers in both adult and pediatric populations. Moreover, Bayer’s focus on non-small cell lung cancer (NSCLC) will be evident through its presentation on the study design of the SOHO-02 trial, which evaluates the effects of BAY 2927088, an oral small molecule tyrosine kinase inhibitor (TKI) under development as a potential new therapy for patients with HER2-positive NSCLC.

Oncology Focus: Bayer Highlights Innovative Therapies for Prostate Cancer at ESMO 2024, Strengthening Evidence for Darolutamide and Radium-223
This trial aims to determine whether BAY 2927088 can provide a new first-line treatment option for patients with HER2-activating mutations, offering another precision medicine approach to cancer care. The SOHO-02 trial builds on the findings of the earlier SOHO-01 study and represents Bayer’s broader effort to address lung cancers driven by specific genetic mutations.
Overall, Bayer’s presentations at ESMO 2024 reflect the company’s growing commitment to developing therapies for some of the most challenging cancers. Prostate cancer remains a primary area of focus, with Bayer’s efforts to improve treatment outcomes through innovative therapies like darolutamide and radium-223 dichloride. Both therapies have already achieved approval in numerous markets, and the new data from ARANOTE and PEACE-III will contribute to the growing body of evidence supporting their use in extending survival and improving the quality of life for prostate cancer patients.
In conclusion, Bayer’s oncology portfolio continues to expand, with promising results from trials across different types of cancer. The company’s presentations at ESMO 2024 highlight the success of targeted therapies like darolutamide, radium-223 dichloride, larotrectinib, and BAY 2927088 in addressing the needs of patients with difficult-to-treat cancers. By focusing on innovative, precision-based approaches, Bayer is providing new hope for patients and healthcare providers, aiming to deliver better treatment outcomes and improve the quality of life for cancer patients worldwide.
Resource: Bayer, September 5, 2024
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