NICE recommends Bayer’s NUBEQA®▼(darolutamide), a new treatment option for non-metastatic castration-resistant prostate cancer

NICE recommends Bayer’s NUBEQA^®▼(darolutamide), a new treatment option for non-metastatic castration-resistant prostate cancer

• Positive recommendation based on Phase III ARAMIS trial data in which darolutamide plus androgen deprivation therapy (ADT) showed a statistically significant improvement in metastasis-free survival (MFS), with a median 40.4 months, compared to 18.4 months for placebo plus ADT (HR 0.41, p<0.001)^1,2
• Darolutamide demonstrated a generally manageable safety profile to date²
• Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving darolutamide plus ADT, had a significant improvement in overall survival (OS) compared to placebo plus ADT, with a 31% reduction in risk of death (HR 0.69, 95% Cl 0.53-0.88; p=0.003)³
• nmCRPC is an advanced stage prostate cancer that continues to progress even after hormone therapy.⁴

Reading, 23 October 2020 – Bayer announced today that the National Institute for Health and Care Excellence (NICE) has recommended NUBEQA^® (darolutamide) with androgen deprivation therapy (ADT), within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high-risk of developing metastatic disease (also known as non-metastatic castration-resistant prostate cancer).¹

Darolutamide, an oral, non-steroidal androgen receptor inhibitor (ARi), in combination with androgen deprivation therapy (ADT), is the first treatment NICE has recommended in this indication.

“NICE’s positive recommendation of darolutamide helps to address an unmet need for hormone-relapsed non-metastatic prostate cancer or, as it is known, non-metastatic castration-resistant prostate cancer (nmCRPC) patients,” said Professor Amit Bahl, Consultant Clinical Oncologist, University Hospitals Bristol NHS Foundation Trust. “A new treatment option that significantly delays the development of metastases whilst also prolonging life, with a generally manageable safety profile is imperative for men diagnosed with nmCRPC, as we aim to ensure minimal disruption to their treatment and day-to-day lives. Men with nmCRPC typically have no symptoms so it’s critical that they can be treated early to delay the prostate cancer from spreading.”

NICE’s decision is based on the positive results of the Phase III ARAMIS trial, evaluating the efficacy and safety of darolutamide plus ADT, compared to placebo plus ADT. In the ARAMIS trial, darolutamide plus ADT demonstrated a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median 40.4 months, compared to 18.4 months for placebo plus ADT (HR 0.41, p<0.001).² Darolutamide demonstrated a generally manageable safety profile to date, when compared to ADT alone.² The incidence of adverse events (AEs) after the start of treatment was similar in the two groups; no new safety signals were observed.³ The incidences of most of the AEs of interest, including falls, seizures, hypertension, mental-impairment disorders, and depressed-mood disorders, showed little or no difference between the darolutamide group and the placebo group.³ Importantly, discontinuation of treatment due to AEs was unchanged from the primary analysis, occurring in 9% of patients in both arms of the study.^2,3

The final overall survival (OS) data, a secondary endpoint from the ARAMIS trial, demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death (HR 0.69, 95% CI 0.53-0.88; p=0.003).³ The overall survival rate at three years was 83% (95% Cl 80-86%) in the darolutamide group and 77% (95% Cl 72-81%) in the placebo group.³

All other secondary endpoints from the ARAMIS trial were statistically significant.³ Darolutamide plus ADT significantly delayed the median time to pain progression compared to placebo plus ADT (40.3 months and 25.4 months respectively; HR 0.65 [95% CI 0.53–0.79]; p<0.001]).³ Furthermore, men receiving darolutamide plus ADT had a significant delay in time to first cytotoxic chemotherapy (HR 0.58 [95% CI 0.44-0.76]; p<0.001) and time to first symptomatic skeletal event (HR 0.48; [95% CI 0.29-0.82]; p=0.005) compared to placebo plus ADT.³

In the UK, prostate cancer is the most common cancer in men, with over 48,000 new cases every year, on average.⁵ Prostate cancer that is confined to the prostate region can be treated with hormone therapy, such as ADT.² However, when the cancer continues to progress, even when the amount of testosterone is reduced to very low levels in the body, it is known as nmCRPC.⁴ Given that approximately a third of men with nmCRPC develop metastases within two years,⁴ delaying the development of metastases in nmCRPC patients is a key therapeutic goal.²

“Bayer welcomes NICE’s positive recommendation for darolutamide, ensuring men with nmCRPC who are at high risk of developing metastatic disease have access to therapeutic options that delay disease progression, whilst improving overall survival, when compared to placebo and ADT alone. Bayer is dedicated to research that aims to address the unmet need in the way cancer is treated, with a particular focus on prostate cancer,”said Dr Melissa Rowe, Director of Medical Affairs for Specialty Medicine at Bayer UK.