Bayer’s NUBEQA: Breakthrough in Prostate Cancer with 46% Risk Reduction and Future FDA Expansion Plans

In the Phase III ARANOTE trial, presented at ESMO 2024, NUBEQA (darolutamide) plus ADT showed a 46% reduction in the risk of progression or death. This was compared to placebo plus ADT, with a statistically significant improvement in radiological progression-free survival (HR 0.54; 95% CI 0.41-0.71; P<0.0001). Moreover, NUBEQA plus ADT has demonstrated efficacy in metastatic hormone-sensitive prostate cancer both with and without docetaxel in the ARANOTE and ARASENS trials. Results were consistent with NUBEQA’s established safety profile, with no new safety signals observed. 

Metastatic Hormone-Sensitive Prostate Cancer: 10% of Diagnoses and NUBEQA’s Expanded Efficacy in Combination Therapies

Metastatic hormone-sensitive prostate cancer (mHSPC) spreads beyond the prostate but remains responsive to hormone therapy. In the U.S., mHSPC accounts for about 10% of prostate cancer diagnoses. We typically combine androgen deprivation therapy (ADT) with other treatments to improve outcomes. Patient factors, such as age and comorbidities, influence treatment choices. Therefore, tailoring therapies to individual needs is crucial for optimizing mHSPC care.

NUBEQA (darolutamide) treats non-metastatic castration-resistant prostate cancer and, in combination with docetaxel, metastatic hormone-sensitive prostate cancer. The drug shows promise for mHSPC. It has U.S. approval for use with docetaxel in mHSPC and for non-metastatic castration-resistant prostate cancer (nmCRPC). Furthermore, the ARANOTE and ARASENS trials aim to expand its efficacy understanding, with or without chemotherapy.

ARANOTE Trial: Significant Improvement in rPFS with NUBEQA Plus ADT and Expanded Efficacy in mHSPC

The pivotal Phase III ARANOTE trial assessed the efficacy and safety of NUBEQA plus ADT in mHSPC patients. A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA twice daily or a placebo, both in addition to ADT. The trial demonstrated a statistically significant and clinically meaningful improvement in radiological progression-free survival (rPFS) for NUBEQA plus ADT. “With the positive results from ARANOTE, in addition to the ARASENS data, darolutamide has now demonstrated efficacy and safety data both with and without chemotherapy in mHSPC,” said Fred Saad, Principal Investigator of the ARANOTE trial.

The safety profile of NUBEQA remained consistent with previous studies. Serious adverse events occurred at similar rates between the treatment groups: 23.6% for NUBEQA plus ADT and 23.5% for placebo plus ADT. Discontinuation due to treatment-emergent adverse events was 6.1% in the NUBEQA group, compared to 9% in the placebo group. No new safety signals were observed, underscoring the drug’s established safety profile.

Future Implications: Expanding NUBEQA’s Use in mHSPC and Upcoming FDA Submission

Experts believe ARANOTE findings could broaden NUBEQA’s use in treating mHSPC. “The positive outcomes from the ARANOTE trial provide physicians with additional data that could broaden the use of NUBEQA as a treatment option for more patients with metastatic hormone-sensitive prostate cancer,” said Neal Shore, M.D., Medical Director of Carolina Urologic Research Center. These findings highlight NUBEQA’s potential to benefit mHSPC patients, whether or not they undergo chemotherapy.

Bayer plans to submit ARANOTE data to the U.S. Food and Drug Administration (FDA) to expand NUBEQA’s use in mHSPC. Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division, stated, “Our goal is to expand the option of NUBEQA to as many patients as possible.” The results appeared at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology.

Prostate Cancer Statistics and Treatment Overview: 1.4 Million Diagnosed and 10% Present with Metastatic Disease

Prostate cancer ranks as the second most common cancer in men and the fifth leading cause of cancer death worldwide. In 2020, doctors diagnosed approximately 1.4 million men with prostate cancer, including nearly 300,000 cases in the U.S. Additionally, about 375,000 men died from the disease worldwide.

At diagnosis, most men have localized prostate cancer. Their cancer remains confined to the prostate gland and can be treated with curative surgery or radiotherapy. When the disease relapses and metastasizes, ADT becomes the cornerstone of treatment for this hormone-sensitive condition. Approximately 10% of men will present with mHSPC at first diagnosis. They will begin treatment with hormone therapy, such as ADT, an androgen receptor inhibitor (ARi) plus ADT, or a combination of chemotherapy docetaxel and ADT. Despite these treatments, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

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Author

Bernice Lottering