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38606411000001106

New Medicines

Nubeqa Metastatic hormone-sensitive prostate cancer (mHSPC) - in combination with androgen deprivation therapy and docetaxel

Information

Nubeqa
Licence extension / variation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
May 22FDA awards Nubeqa priority review status. The FDA is reviewing the application under the Project Orbis initiative, which allows multiple countries to concurrently review submissions. The label expansion would allow Nubeqa to compete with Xtandi and Erleada [11].
Mar 22Filed in EU and US for use in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC)[10].
Feb 22On basis of data from PIII ARASENS trial, Bayer intends to file applications for license extension of darolutamide with US FDA and other regulatory agencies [8].

Category

Androgen receptor antagonist
Prostate cancer (PC) is the most common male cancer in the UK, with more than 35,000 new cases diagnosed annually. In the UK, the incidence of PC is 97 per 100,000 people.
Metastatic hormone-sensitive prostate cancer (mHSPC) - in combination with androgen deprivation therapy and docetaxel
Oral

Further information

Yes

Trial or other data

Feb 22Results of PIII ARASENS trial are published in NEJM. Adding darolutamide to SOC significantly reduced risk of death by 32.5% vs. ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001). At the data cut off date for the primary analysis median treatment duration was 41.0 months for darolutamide plus ADT and docetaxel vs. 16.7 months for ADT plus docetaxel [7,8].
Dec 21 PIII ARASENS trial has met its primary endpoint. Darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms [6]
Dec 20PIII ARASENS study now expected to complete collection of primary outcome data in Jun 21 [5].
Dec 19PIII ARASENS study is no longer recruiting; timescales unchanged [4].
Aug 18PIII ARASENS (NCT02799602) has recruited in a number of UK and US sites. Study completion now expected Aug 2022 [3].
Jun 16PIII ARASENS (NCT02799602) study is to assess efficacy and safety of BAY1841788 (ODM-201) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer. 1,300 adult men will be recruited from sites in Belgium, Italy, Israel & Spain. Primary outcome is overall survival; collection of these data should complete Jan 22 [2].

Nubeqa Metastatic hormone-sensitive prostate cancer (mHSPC) - in combination with androgen deprivation therapy

Information

Nubeqa
Licence extension / variation
Bayer
Bayer

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Androgen receptor antagonist
The age-standardised incidence of prostate cancer in England in 2016 was 173.7 per 100,000 in 2016 [1].
Metastatic hormone-sensitive prostate cancer (mHSPC) - in combination with androgen deprivation therapy
Oral

Nubeqa Localised prostate cancer in men having radiation therapy at very high risk of recurrence - adjuvant therapy with androgen deprivation therapy

Information

Nubeqa
Licence extension / variation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Androgen receptor antagonist
1 in 6 UK males will be diagnosed with prostate cancer (PCa) in their lifetime. In males in the UK, prostate cancer is the most common cancer, with around 52,300 new cases every year. Incidence rates for prostate cancer in the UK are highest in males aged 75-79. Each year around a third (34%) of all new prostate cancer cases in the UK are diagnosed in males aged 75 and over [1].
Localised prostate cancer in men having radiation therapy at very high risk of recurrence - adjuvant therapy with androgen deprivation therapy
Oral