The addition of darolutamide (Nubeqa) to androgen deprivation remedy (ADT) led to a statistically vital and clinically significant enchancment in radiological progression-free survival (rPFS) vs placebo plus ADT in sufferers with metastatic hormone-sensitive prostate most cancers (mHSPC), assembly the first finish level of the part 3 ARANOTE trial (NCT04736199).1
The security profile of darolutamide within the trial was in step with its established profile, and no new antagonistic results had been reported. A extra complete evaluation of the examine outcomes is anticipated to be introduced at an upcoming medical assembly and mentioned with the FDA concerning submission for regulatory approval.
“We’re excited to share the constructive outcomes from this part 3 trial. Following potential regulatory approval, physicians will have the ability to tailor darolutamide therapy plans with or with out docetaxel based mostly on particular person affected person’s wants,” Christian Rommel, PhD, head of Analysis and Improvement at Bayer’s Prescribed drugs Division, said in a information launch.1 “At present’s outcomes construct on the established efficacy and tolerability profile of darolutamide. We’re trying ahead to future outcomes of our medical growth program investigating the compound throughout a number of prostate most cancers levels and indications.”
Darolutamide is at present indicated by the FDA to be used together with docetaxel for the therapy of sufferers with mHSPC in addition to for sufferers with nonmetastatic castration-resistant prostate most cancers.2
Previous to the learn out of ARANOTE, darolutamide displayed a statistically vital enchancment in total survival (OS) together with docetaxel vs placebo plus docetaxel in sufferers with mHSPC enrolled within the part 3 ARASENS trial (NCT02799602). Outcomes from the trial demonstrated a 32% discount within the danger of dying with the addition of the AR inhibitor vs docetaxel alone (HR, 0.68; 95% CI, 0.57-0.80; P < .0001). Knowledge from this trial served as the premise for the agent’s current indication in mHSPC.
With these outcomes darolutamide now has constructive information from two pivotal part 3 trials with and with out docetaxel in mHSPC.
In ARANOTE, a double-blind, placebo-controlled trial, investigators randomly assigned 669 sufferers to obtain 600 mg of darolutamide by the use of 2, 300-mg tablets twice day by day with meals or matching placebo, plus investigator’s alternative of ADT.3
Eligible sufferers included these with histologically or cytologically confirmed adenocarcinoma of the prostate with proof of metastatic illness, an ECOG efficiency standing of 0 to 2, and ample bone marrow, liver, and renal perform. As well as, sufferers needed to have began ADT with both a luteinizing hormone-releasing hormone agonist or antagonist or orchiectomy with or with no first-generation anti-androgen no earlier than 12 weeks previous to randomization.
The first finish level of the examine is rPFS, outlined because the time from the date of random task to the date of first documentation of radiological progressive illness or dying from any trigger. Secondary finish factors embrace total survival, time from randomization to the date of dying from any trigger, time from randomization to the date of first castration-resistant occasion, time to initiation of subsequent anti-cancer remedy, time to prostate-specific antigen (PSA) development, PSA undetectable charges, time to ache development, and security.
Darolutamide can also be below analysis in a number of different trials together with the part 3 ARASTEP trial (NCT05794906), which is evaluating darolutamide plus ADT vs ADT alone in sufferers who’ve HSPC and high-risk biochemical recurrence with out proof of metastatic illness by typical imaging in addition to the part 3 DASL-HiCaP trial (ANZUP1801; NCT04136353), which is evaluating darolutamide as adjuvant remedy for sufferers with localized prostate most cancers who’ve a really excessive danger of recurrence.1
References
- Bayer broadcasts constructive topline outcomes for NUBEQA (darolutamide) from part III trial in males with metastatic hormone-sensitive prostate most cancers (mHSPC). Information launch. Enterprise Wire. July 17, 2024. Accessed July 17, 2024. https://www.businesswire.com/information/house/20240716341886/en
- Nubeqa. Prescribing info. Bayer; 2024. Accessed July 17, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212099s002lbl.pdf
- Darolutamide along with ADT versus ADT in metastatic hormone-sensitive prostate most cancers (ARANOTE). ClinicalTrials.gov. Up to date July 16, 2024. Accessed July 17, 2024. https://clinicaltrials.gov/examine/NCT04736199
