Promising Data on Drug Nubeqa Could Mean Better Targeted Treatments for Men With Advanced Prostate Cancer

This new study showed that this combination significantly increased the time patients lived without their cancer getting worse, compared to patients who received a placebo plus ADT. This measure is known as radiological progression-free survival (rPFS).

The safety results of the trial were consistent with what is already known about Nubeqa, meaning no new safety concerns were found.

More detailed results from the study will be shared at an upcoming meeting for cancer research professionals.

How Does Nubeqa Help?

“Nubeqa, or darolutamide, is the fourth in a list of novel hormonal agents — or second generation androgen receptor directed therapies that we now have in the market,” says Dr. David Wise, medical oncologist, cancer researcher and director of urologic medical oncology at NYU Langone Perlmutter Cancer Center.

“It really was developed in a very specific way,” Dr. Wise explains to SurvivorNet. “And the most recent approval, which has really led to its incorporation into the standard of care for many men, is its incorporation into the triplet therapy paradigm for men who are diagnosed with metastatic hormone sensitive prostate cancer.”

This medication belongs to a class of drugs known as anti-androgens or anti-testosterone. It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

Currently, Nubeqa is approved by the U.S. Food and Drug Administration (FDA) to treat mHSPC, but only in combination with docetaxel chemotherapy.

“At the time of initial diagnosis, if a man has more than four bone metastases with one outside the spine or pelvic area or with metastasis in the lung or liver, and the oncologist believes that these men need chemotherapy and hormonal suppression, we now have data that these men should not be treated with just those two medications, or that doublet,” Dr. Wise says.

“The chemo hormonal therapy doublet should not be the standard anymore. It should always be a triplet of chemotherapy plus hormonal suppression plus Nubeqa.”

Based on these new results, Bayer plans to seek approval for using Nubeqa with ADT alone, without additional chemotherapy. This could allow doctors to tailor treatment plans based on individual patient needs.

What’s the Data Show?

The ARANOTE trial is a randomized, double-blind, placebo-controlled phase III study. A phase III clinical trial tests the effectiveness and safety of a new treatment on a large group of people to confirm its benefits and monitor side effects. This type of trial is considered a “high evidence” study.

The ARANOTE was designed to assess the efficacy and safety of Nubeqa plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

In the study 669 patients were randomized to receive 600mg of Nubeqa twice daily or matching placebo in addition to ADT.

The study demonstrated that:

• The combination of Nubeqa and ADT significantly prolonged the period during which patients lived without their cancer worsening, compared to those who received a placebo plus ADT (this outcome is referred to as radiological progression-free survival or rPFS)
• Safety results were in line with the known safety profile of Nubeqa, with no new safety issues identified

The study is estimated to be completed in September of 2025, according to its listing on clinicaltrials.gov.

What to Know About Taking Nubeqa

This medication is taken by mouth and with food, as directed by your doctor. It’s usually taken twice a day.

The below instructions should be followed:

• Swallow the tablet whole
• Do no chew, crush or split the pills
• Follow the prescription directions
• Do not increase or decrease your dose

What are the Side Effects?

“Across the board, the bane of chemotherapy is fatigue,” Dr. Neal Shore, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, told SurvivorNet in a previous conversation. “Nubeqa, which is otherwise well-tolerated, is no exception.”

As Dr. Shore points out: “Fatigue is often compounded by the patient’s advanced age.”

Other common side effects include:

• Arm, leg, hand or foot pain
• Rash
• A decrease in white blood cell count (neutropenia)
• Changes in liver function
• A rise in blood pressure
• A lowered ability to fight infections

It’s important to get in touch with your doctor right away if you experience any of the following side effects:

• Severe ongoing nausea or diarrhea
• Painful or difficult urination
• Blood in your urine
• Severe headache, blurred vision, pounding in your neck or ears
• Slowed heart rate, weak pulse, fainting, slow breathing
• Signs of blood clot in the lung which can be experienced by chest pain, sudden cough, wheezing, rapid breathing
• Signs of a lung infection which can be experienced with fever, chills, cough with mucus, chest pain, shortness of breath

Get emergency help right away if you experience signs of an allergic reaction to Nubeqa, which includes:

• Hives
• Difficulty breathing
• Swelling of your face, lips, tongue or throat

Questions to Ask Your Doctor

Here are some questions you may consider asking your doctor to help understand your situation and whether this drug may make sense for you:

• Am I eligible to take Nubeqa alone or with another drug?
• What side effects can I expect and how will we manage them?
• Am I more, or less, likely to respond to this treatment?
• What part of my treatment is covered by insurance and how much can I expect to pay out of pocket?
• Are there any clinical trials I should consider?

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