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Darolutamide Shows Promise In Phase III ARANOTE Trial For Treating Prostate Cancer
Darolutamide combined with ADT significantly extends progression-free survival in men with metastatic hormone-sensitive prostate cancer, compared to standard treatment. This finding could lead to expanded treatment options, thereby improving outcomes and enhancing the quality of life for patients.
The ARANOTE Phase III trial demonstrated that Nubeqa (darolutamide), combined with androgen deprivation therapy (ADT), can significantly improve radiological progression-free survival (rPFS) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The trial's safety data reaffirm darolutamide's established tolerability profile.
These promising results pave the way for Bayer to seek global regulatory approval, potentially expanding treatment options for advanced prostate cancer patients and marking a significant advancement in personalized cancer therapy.
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Expanding Treatment OptionsDarolutamide is already a well-established treatment under the brand name Nubeqa™ for non-metastatic castration-resistant prostate cancer (nmCRPC). The new findings could expand its use, providing a vital treatment avenue for patients diagnosed with mHSPC, with or without the addition of the chemotherapy drug docetaxel.
Dr. Christian Rommel, Head of Research and Development at Bayer's Pharmaceuticals Division, expressed optimism about the implications of the trial's results. "Following potential regulatory approval, physicians can tailor treatment plans with or without docetaxel based on individual patient´s needs. Today's results build on the established efficacy and tolerability profile for Nubeqa™. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications," he stated.
The ARANOTE TrialThe ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. A total of 669 patients were randomized to receive 600 mg of darolutamide twice daily or a matching placebo in addition to ADT. Safety analyses indicated that the side effects of darolutamide combined with ADT are comparable to those of the placebo group, confirming darolutamide's safety profile as previously observed in other major studies, such as the ARAMIS and ARASENS trials.
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Future ImplicationsThe detailed results of the ARANOTE trial are expected to be presented at a forthcoming scientific congress. Bayer plans to submit these findings to health authorities globally, aiming to extend the indication of darolutamide for broader use in prostate cancer treatment.
The Broader Impact of mHSPCProstate cancer remains a major health challenge globally, being the second most common cancer in men and a leading cause of cancer-related death. The diagnosis of mHSPC, where the cancer has spread beyond the prostate gland, presents significant treatment challenges. Up to 10% of men are diagnosed with mHSPC at the initial diagnosis, often necessitating intensive treatment regimes including ADT and chemotherapy.
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Bayer Plans Filings For Prostate Cancer Drug Darolutamide
Bayer is planning regulatory filings of darolutamide in prostate cancer following phase III trial results showing it helped prevent the disease from spreading, in a niche where Pfizer and Johnson & Johnson have already gained a foothold.
The German pharma developed darolutamide in partnership with Finland's Orion Corporation, with the latter due a series of payments when the drug is filed in major markets.
The ARAMIS trial tested darolutamide in men with non-metastatic castration resistant prostate cancer (nmCRPC), to see if the drug could stop the disease from metastasising.
Pfizer's Xtandi (enzalutamide) has been approved as a way of preventing the disease from spreading after the FDA expanded its label earlier this year, and J&J's newer drug Erleada (apalutamide) was also approved in this indication earlier this year.
Results from ARAMIS showed darolutamide significantly extended metastasis-free survival (MFS) compared to placebo.
The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.
ARAMIS is a randomised, multi-centre, double-blind, placebo-controlled trial in more than 1,500 patients with nmCRPC treated with androgen deprivation therapy as standard of care and who are at risk of developing metastatic disease.
The primary endpoint of this trial is metastasis-free survival (MFS) defined as time between randomisation and evidence of metastasis or death from any cause.
The secondary objectives of this trial are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression and characterisation of the safety and tolerability of darolutamide.
Scott Fields, head of oncology development at Bayer's pharmaceutical division, said: "Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options that delay the time to metastases with a manageable safety profile.
"We are encouraged by the results of the ARAMIS trial and look forward to presenting the full data at an upcoming scientific meeting."
Bayer plans to discuss the data from the ARAMIS trial with regulators, and the FDA has granted it a Fast Track designation, potentially setting up a faster six-month data review.
Under the terms of a deal announced in 2014 Orion is eligible to receive payments of 45 million euros, 20 million euros and 8 million euros upon the first commercial sale in the US, EU and Japan, respectively
Orion will also receive tiered royalties on the product sales, which will be approximately 20%, including production revenue. With sales increase, royalties may increase slightly. Orion may receive one-off payments from Bayer if certain sales targets are met.
Orion and Bayer have an ongoing phase 3 clinical trial (ARASENS) which evaluates the safety and efficacy of darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Expected to be completed in 2022, there are no separate milestone payments related to the ARASENS trial.
Bayer/Orion's Darolutamide Combination Shows Promise In Phase 3 Prostate Cancer Trial
Bayer and Orion's darolutamide has demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to new late-stage results shared by the companies.
The phase 3 ARANOTE trial randomised more than 660 patients to receive 600mg of darolutamide twice daily or matching placebo, both in addition to androgen deprivation therapy (ADT).
The study met its primary endpoint, with the darolutamide combination significantly increasing radiological progression-free survival compared to placebo plus ADT.
The darolutamide combination also had a safety profile comparable to that of placebo plus ADT.
Prostate cancer is the second most common cancer in men, with an estimated 1.4 million cases diagnosed globally in 2020.
ADTs are often used as part of a combination treatment for patients with mHSPC, a stage of the disease in which the cancer has spread outside of the prostate to other parts of the body. However, most of those with mHSPC eventually progress to castration-resistant prostate cancer, at which point survival is limited.
Darolutamide, jointly developed by Bayer and Orion, is an oral androgen receptor inhibitor that works to impede the receptor function and the growth of prostate cancer cells.
The drug already holds approvals, under the brand name Nubeqa, to treat non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease, and in combination with ADT and docetaxel for those with mHSPC.
Commenting on the latest results for the therapy, Outi Vaarala, senior vice president of innovative medicines and research and development at Orion, said: "The results of the ARANOTE trial reconfirm that darolutamide… is a viable treatment option for patients with mHSPC.
"In these patients, darolutamide has now shown efficacy with and without docetaxel, and thus, pending regulatory approval, can provide choices for the personalised treatment regime."
Bayer is now set to present detailed results from the study at an undisclosed scientific congress and will submit the data to global health authorities to support expanded use of darolutamide in mHSPC.
Beyond mHSPC, darolutamide is currently being evaluated across other stages of prostate cancer, including hormone-sensitive high-risk biochemical recurrence disease.
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