Bayer today announces that the Scottish Medicines Consortium (SMC) has published advice on two Bayer cancer drugs, recommending both for use in NHSScotland: NUBEQA®▼ (darolutamide) + ADT in combination with docetaxel as a treatment option for patients with metastatic hormone-sensitive prostate cancer (mHSPC)1 and STIVARGA® (regorafenib) as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies (these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)4.
Darolutamide plus androgen deprivation therapy (ADT) + docetaxel in mHSPC
Today’s Advice from the SMC allows eligible patients with mHSPC in Scotland to receive this medication in combination with ADT and docetaxel. It follows the publication of the NICE guidance on darolutamide + ADT in combination with docetaxel for mHSPC patients in England and Wales in June 2023.7 Darolutamide received the accelerated regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for mHSPC patients in November 2022.2 Subsequently, Bayer announced an early access commercial agreement between Bayer and NHS England3, which allowed early access for a few hundred eligible patients with mHSPC to receive the medication in England8 ahead of the publication of the NICE guidance, making darolutamide + ADT in combination with docetaxel the first triple combination treatment made available by the NHS in England for patients with mHSPC2,3.
In Scotland, prostate cancer is the most common cancer in males with around 3,394 new cases diagnosed in 20209, it is estimated that almost a third (29%) of these were diagnosed at a late stage when the disease had metastasised.9
Professor Rob Jones, University of Glasgow, said: “Probably the most important discovery in the treatment of advanced prostate cancer in recent years is that patients gain most benefit from anti-cancer medicines if they receive them early after the diagnosis. This decision means that Scottish patients can now benefit from a wider choice of early treatment options after diagnosis with advanced prostate cancer. I’d also like to pay tribute to the patients in Scotland and elsewhere who took part in the clinical trial which demonstrated the benefits of this treatment.”
The Advice given by the SMC followed a submission assessed under the orphan medicine process and is based on the results from 1,305 patients who participated in the ARASENS clinical trial.10 This randomised, Phase III, multi-centre, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety profile of oral darolutamide + ADT in combination with docetaxel in patients with mHSPC. Results showed that the combination treatment led to a statistically significant 32.5% reduced risk of death (HR=0.68, HR 95% CI[0.57; 0.80; p<0.0001]).10,11Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months).10,11
Chiara De Biase, Director of Support & Influencing at Prostate Cancer UK, said: “I’m extremely pleased that men in Scotland can now benefit from this first-of-its-kind combination treatment which we know can give a man with advanced prostate cancer a longer life. This innovative triple therapy will not only help the men who need it now, but also paves the way to future combination treatments that have the potential to be even more effective.
“We'll continue to engage with healthcare professionals and researchers to help establish which men most benefit from this approach, so that every man gets the most effective treatment tailored to his disease. We face huge regional health inequalities in the UK. For example, 1 in 3 men diagnosed in Scotland have advanced prostate cancer at diagnosis, compared to 1 in 8 men in London. Today’s decision will contribute to closing that unfair gap, as men across the whole of the UK can finally benefit from this advancement in treatment options.”
“The Advice by the SMC now opens the doors to patients in Scotland who may be eligible to benefit from this innovative treatment, following the early access we agreed with NHS England at the end of 2022,” said Antonio Payano, CEO Bayer UK & Ireland, adding: “We are resolutely committed to investigating the potential of darolutamide in prostate cancer to help make it available to as many eligible patients as possible.”
Darolutamide was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. It is currently approved for the treatment of patients with mHSPC in combination with ADT and docetaxel and for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.2 It is also being investigated in further studies across various stages of prostate cancer.