NUBEQA Meets Primary Endpoint for Phase III ARANOTE Trial in Men with Prostate Cancer
The androgen receptor inhibitor significantly increased radiological progression-free survival in combination with androgen deprivation therapy compared to placebo.
The Phase III ARANOTE trial (NCT04736199) of Bayer’s NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of radiological progression-free survival (rPFS). Overall, NUBEQA plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.1
ARANOTE is a randomized, double-blind, placebo-controlled study.2 The trial had 669 participants that were randomized to receive 600mg of NUBEQA twice daily or matching placebo in addition to ADT. Secondary endpoints of the study include overall survival, time from randomization to the date of death from any cause, and time from randomization to the date of first castration-resistant event.
According to Bayer, results of the trial were consistent with NUBEQA’s established safety profile with no new signals observed. The organization plans to present more detailed results at a scientific conference. Bayer also has plans to meet with the FDA to explore the next steps for submission for regulatory approval.
“We are excited to share the positive results from this Phase III trial. Following potential regulatory approval, physicians will be able to tailor NUBEQA treatment plans with or without docetaxel based on individual patient’s needs,” Christian Rommel, PhD, head of research and development at Bayer’s pharmaceuticals division said in a press release. “Today’s results build on the established efficacy and tolerability profile of NUBEQA. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications.”
Outside of skin cancer, prostate cancer is the most common cancer in men in the United States. According to the American Cancer Society, about 35,250 are expected to die of prostate cancer in 2024. About 1 in 8 men will be diagnosed with the disease during their lifetime.3
Additionally, NUBEQA is currently indicated in the US for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
The NUBEQA-docetaxel combination for the treatment of mHSPC was approved by the FDA in 2022. The decision was based on results from the pivotal Phase III ARASENS trial (NCT02799602), which showed a significant overall survival benefit with NUBEQA plus ADT and docetaxel compared to ADT and docetaxel.4
The ARASENS trial was randomized, double-blind, placebo-controlled, multicenter study.5 A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and 75 mg/m2 of docetaxel, for 6 cycles.
In addition to meeting its primary endpoint, results of the study showed there was a reduction in the risk of death by 32% for those who were treated with NUBEQA plus docetaxel and ADT compared with ADT and docetaxel.
References
1. Bayer announces positive topline results for NUBEQA® (darolutamide) from Phase III trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). News release. Bayer. July 17, 2024. Accessed July 18, 2024. https://www.businesswire.com/news/home/20240716341886/en/Bayer-announces-positive-topline-results-for-NUBEQA%C2%AE-darolutamide-from-Phase-III-trial-in-men-with-metastatic-hormone-sensitive-prostate-cancer-mHSPC
2. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). ClinicalTrials.gov. Accessed July 18, 2024. https://clinicaltrials.gov/study/NCT04736199
3. Key Statistics for Prostate Cancer. American Cancer Society. January 19, 2024. Accessed July 18, 2024. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
4. U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). News release. Bayer. August 5, 2022. Accessed July 18, 2024. https://www.businesswire.com/news/home/20220805005477/en
5. Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (ARASENS). ClinicalTrials.gov. Accessed July 18, 2024. https://clinicaltrials.gov/study/NCT02799602
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