Oncologists and patient group welcome new therapy for advanced prostate cancer

Pharma News: The Therapeutic Goods Administration (TGA) has registered a second indication for Bayer’s androgen receptor inhibitor as a triple combination therapy for advanced prostate cancer.

First registered by the TGA for early-stage prostate cancer in 2020, this new registration for oral Nubeqa (darolutamide) will expand the drug’s use to metastatic hormone-sensitive prostate cancer (mHSPC) in combination with the existing standard of care chemotherapy (docetaxel) and hormone therapy (androgen-deprivation therapy or ADT).

Positive results from the phase 3 ARASENS trial showed Nubeqa combination therapy reduced the risk of death in mHSPC patients by 32.5%. Apart from hitting its overall survival endpoint, Nubeqa charted a statistically significant delay in time to pain progression.

Oncologist Professor Arun Azad, Peter MacCallum Cancer Centre, said the new combination approach will come as great news to men whose prostate cancer has spread.

“Prostate cancer generally has a good chance of survival, as it can be closely monitored, and you can intervene early with treatment options. However, with metastatic disease, once the cancer has spread, things become a lot more challenging. When we find the disease after it has become metastatic, it’s referred to as ‘de-novo’, and represents around 45% of metastatic cases. The de-novo form of mHSPC is aggressive and associated with worse survival rates,” commented Professor Azad.

“This TGA registration of Nubeqa in mHSPC is important, because it offers a large group of men, who previously had very few treatment options, access to an effective new treatment. As soon as metastatic disease is detected, there is no need to delay and we can initiate treatment.”

New subgroup analyses from the pivotal Phase III ARASENS trial presented at the recent ASCO GU Cancers Symposium supports overall survival (OS) benefits of Nubeqa triple therapy in patients with high-volume and high and low-risk metastatic hormone-sensitive prostate cancer (mHSPC). Low-volume disease was also assessed with results suggestive of a survival benefit.

Prostate Cancer Foundation of Australia CEO, Professor Jeff Dunn, welcomed the TGA’s registration.

He stated “Any step forward in this disease area is a huge milestone to be celebrated and we’re grateful to the TGA for registering this treatment.

“Over 200,000 men are currently living with prostate cancer in Australia. This year, it’s estimated that more than 24,000 men will be diagnosed, and every year approximately 3,500 lose their lives to the disease. Prostate cancer has long been categorised as an ‘easy cancer’, that men can live with while doctors ‘watch and wait’. But for some men, it can progress to advanced disease that requires intensive treatment and has a significant impact on quality of life.”

Bayer Pharmaceuticals ANZ General Manager, Ashraf Al-Ouf, commented “Prostate cancer has now overtaken breast cancer as Australia’s most-diagnosed cancer and, particularly in its advanced form, is rapidly emerging as a national health priority, with daily calls for better diagnosis and treatment options.

“We hope that the TGA’s registration of Nubeqa in mHSPC, along with the news of our access program for eligible patients currently suffering from this disease, can become the first steps toward improved outcomes for these men.”

Reimbursement for Nubeqa via the Pharmaceutical Benefits Scheme (PBS) remains the next ambition for Bayer. The company is initiating a patient access program for eligible mHSPC patients while waiting for its submission to be evaluated.

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