Orion’s collaboration partner Bayer submits application for third indication of darolutamide in the EU
- Bayer has submitted an application to the European Medicines Agency for the approval of darolutamide in combination with androgen deprivation therapy (ADT) for treating patients with metastatic hormone-sensitive prostate cancer (mHSPC), highlighting its commitment to expanding treatment options.
- The ARANOTE trial, a Phase III study involving over 660 patients, demonstrated that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT, and showed a favorable safety profile.
- Bayer's strategic move to expand darolutamide's indications reflects ongoing efforts in collaboration with Orion Corporation to develop innovative treatments for prostate cancer, with further studies underway to explore additional applications of the drug across different stages of the disease.
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A New Hope for Prostate Cancer Patients
In a significant development for prostate cancer treatment, Bayer has announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. This application seeks approval for darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The move underscores Bayer’s commitment to expanding treatment options for men with this aggressive form of prostate cancer.
Background on Darolutamide
Darolutamide, which is already approved under the brand name Nubeqa™ in over 80 markets around the world, is a novel oral androgen receptor inhibitor (ARi). It has shown promise in treating non-metastatic castration-resistant prostate cancer (nmCRPC), particularly in patients at high risk of developing metastatic disease. Its efficacy in mHSPC has been further validated through the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction in the risk of radiological progression or death by 46% when combined with ADT compared to placebo plus ADT.
The ARANOTE Trial: A Landmark Study
The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of darolutamide in combination with ADT in men with mHSPC. The trial involved over 660 patients, all of whom received either 600mg of darolutamide twice daily or a matching placebo, both in addition to standard ADT. The primary endpoint of this study was radiological progression-free survival (rPFS), which measures the time from randomization to the first documentation of radiological progressive disease or death due to any cause.
Positive Results from ARANOTE
The results of the ARANOTE trial have been nothing short of impressive. Darolutamide plus ADT demonstrated a statistically significant increase in rPFS compared to placebo plus ADT. This indicates that darolutamide not only extends the time before the cancer progresses but also improves survival rates for men with mHSPC. The safety profile of darolutamide was found to be comparable to that of placebo plus ADT, with low incidence rates of treatment-emergent adverse events (TEAEs). The most commonly reported adverse events included anemia, arthralgia, and urinary tract infections, though the incidence of fatigue was lower in the darolutamide arm.
Expanding Treatment Options
The submission of darolutamide for its third indication in the EU is a strategic move by Bayer to broaden the therapeutic armamentarium for prostate cancer patients. Currently, darolutamide is approved for use in combination with ADT for nmCRPC patients at high risk of developing metastatic disease and in combination with ADT and docetaxel for mHSPC patients. This new application aims to provide another viable treatment option for men with mHSPC, who often face limited survival rates once their cancer progresses to a castration-resistant state.
Collaboration and Development
Darolutamide is a product of the joint development efforts between Bayer and Orion Corporation, a Finnish pharmaceutical company. This collaboration has yielded significant advancements in prostate cancer treatment. Orion manufactures the drug products, while Fermion, another subsidiary of Orion, handles the manufacture of the darolutamide API. The partnership between Bayer and Orion has ensured seamless development and commercial production processes, with all milestones met on time and to a high standard.
Future Directions
Beyond its current approvals, darolutamide is being investigated in various stages of prostate cancer. The Phase III ARASTEP trial is evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer. Additionally, the collaborative Phase III DASL-HiCaP trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is assessing darolutamide as an adjuvant treatment for localized prostate cancer with a very high risk of recurrence.
Conclusion
Bayer’s submission of darolutamide for its third indication in the EU marks an important milestone in the fight against prostate cancer. This new application aligns with Bayer’s focus on addressing the unique needs of prostate cancer patients through innovative treatments that extend their lives with minimal disruption to their daily activities. As the pharmaceutical industry continues to evolve, such collaborations and advancements offer new hope for patients and families affected by this prevalent disease.
References
- Bayer’s Press Release on ARANOTE Trial Results
- Orion’s Collaboration Partner Bayer Submits Application for Third Indication of Darolutamide in the EU
- Bayer/Orion’s Darolutamide Combination Shows Promise in Phase 3 Prostate Cancer Trial
- Bayer and Orion Expand Development Program for Darolutamide in Prostate Cancer
- Bayer’s Experiences in Development of API Process for Darolutamide with Fermion
