Bayer and Orion Corporation today announced the upcoming expansion of the global clinical development program for darolutamide (Nubeqa), an oral androgen receptor inhibitor for patients with prostate cancer

Bayer and Orion Corporation today announced the upcoming expansion of the global clinical development program for darolutamide (Nubeqa), an oral androgen receptor inhibitor for patients with prostate cancer, a new phase 3 study, ARANOTE, expected to end in the first quarter of 2021 Will begin recruiting, will investigate darolutamide plus androgen deprivation therapy (ADT) versus ADT and placebo for metastatic hormone-sensitive prostate cancer

Darolutamide was approved by the FDA in 2019 for patients with non-metastatic castration-resistant prostate cancer, based on results from the ARAMIS study (NCT02200614), a double-blind, placebo-controlled, multicenter study of 1509 patients who were randomized 2: 1 to receive either Oral darolutamide (600 mg) twice a day or a placebo All patients received a gonadotropin-releasing hormone (GnRH) analog at the same time or had a bilateral orchiectomy prior to the study

The primary endpoint in the ARAMIS study was metastasis-free survival (MFS), which researchers defined as the time from randomization to distant metastasis or death for any reason within 33 weeks of a patient’s last evaluable scan from the study results , first published in the New England Journal of Medicine, showed a mean MFS of 404 months in the darolutamide cohort (95% CI, 343-not reached) vs 184 months (95% CI, 155-223) in the placebo group / p>

Permanent withdrawal due to adverse events was the same in darolutamide and placebo groups (9%) Adverse reactions observed more frequently in the darolutamide cohort than in the placebo group were fatigue (16% versus 11%), pain in the extremities (6% versus 3%) and rash (3% versus 1%)

Overall survival (OS), a secondary endpoint in the study, was improved in the experimental group.The darolutamide cohort had a 31% reduction in risk of death compared to the placebo group – a statistically significant result despite 31% of the patients in the ADT plus placebo group went into the darolutamide group

The ARANOTE study will be a randomized, double-blind, placebo-controlled phase 3 study of darolutamide plus ADT versus placebo and ADT in patients with metastatic hormone-sensitive prostate cancer. The main endpoint will be radiographic progression-free survival, defined as time from the Randomized to date of first documented radiologically progressive disease or death from any cause. The expected enrollment is approximately 555 men Enrollment is expected to begin at the end of the first quarter of 2021

“Nubeqa has already shown in men with non-metastatic castration-resistant prostate cancer that it increases metastasis-free survival and overall survival,” said Scott Z. Fields, MD, senior vice president and head of oncology development for Bayer’s Pharmaceutical Division, said in a statement, “Given the encouraging results we’ve seen with Nubeqa to date, it is important that we also understand the potential of Nubeqa in other stages of prostate cancer evaluate who may offer a new treatment option for men with metastatic hormone-sensitive prostate cancer ”

The FDA approves darolutamide for non-metastatic castration-resistant prostate cancer FDA 20 July 2019 Accessed 8 February 2021 https: // wwwFDAgovernment / drugs / resources-information-approved-drugs / FDA-approved-darolutamide-non-metastatic-castration-resistant-prostate-cancer

Orion

World News – FI – Bayer, Orion announce expansion of Nubeqa development program

Source: https://www.ajmc.com/view/bayer-orion-announce-expansion-of-nubeqa-development-program