Nubeqa (darolutamide) increases overall survival in men with mCSPC/HSPC when added to androgen-deprivation treatment (ADT) with docetaxel: ARASENS phase III study

According to the findings of the ARASENS trial (NCT02799602), presented by Bayer at the 2022 ASCO GU, Nubeqa resulted in a 32.5% reduction in the risk of death, with a median follow-up of 43.7 months for darolutamide.  Nubeqa provided a consistent overall survival advantage across predefined subgroups. The median OS in the darolutamide arm was not estimable compared to 48.9 months in the placebo arm. At 48 months, the rates of OS were 62.7% for Nubeqa. The safety profile of the two arms was comparable. In conclusion, findings from the phase III ARASENS study indicated that early treatment with Nubeqa with ADT plus docetaxel increased overall survival much more than ADT and docetaxel alone in patients with metastatic-HSPC.

Analyst Opinion:  Given the encouraging findings of Phase III mCSPC study and Nubeqa’s strong performance in nmCRPC thus far, it is fair to believe that Nubeqa’s potential in males with metastatic HSPC will give a new treatment option. According to DelveInsight, this triplet is projected to join the US market in 2022. Following Astella’s Blockbuster drug, Xtandi and Janssen’s Erleada approval in 2018 for nonmetastatic CRPC (nmCRPC), Bayer’s Nubeqa received an approval for nmCRPC in 2019 in the United States. nmCRPC is the first segment in Prostate cancer that Nubeqa received an approval for, and we expect the drug to generate more than 1billion USD by the year 2030. Nubeqa is expected to face stiff competition with Erleada and Xtandi (in both nmCRPC and mHSPC), where Xtandi is expected to lose patent by the year 2027 leading to entry of generics. Needless to mention, Xtandi has already gained its fair share of benefit by reaching approximately USD 4 billion in sales in the year 2020.

Excitingly, Bayer is now focusing towards metastatic Hormone Sensitive Prostate Cancer (mHSPC), which is a less crowded market when compared to mCRPC.  As per Delveinsight’s forecast for mHSPC forecast, we expect Nubeqa to generate approximately 700 million in the 7 Major Markets (US, EU5 and Japan) by 2030. Infact combining nmCRPC market, we expect Nubeqa to generate more than USD 1500 million in revenue in the 7MM by 2030. Apart from Xtandi and Erleada, Myovant’s Relugolix is another recently approved contender for Nubeqa in mHSPC market.

Following approval of Nubeqa in 2022 in mHSPC patient pool, we expect Novartis’ Radioligand Therapy, along with PARP inhibitors to enter the sparse mHSPC market.