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New Indication: Darolutamide Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)

New Indication: Darolutamide Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)
Study:
  • Randomized , phase 2 trial
  • Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane
  • Darolutamide (n=92)
Efficacy:
  • 12 weeks rPFS: 64.7 vs 52.2%, p=0.127
  • Median rPFS: 5.5 vs 4.5 mos , HR:0.54, p=0.017
  • Median EFS: 5.4 vs. 2.9 mos, HR:0.46, p=0.001
  • PSA 50% RR:22 vs. 4%, p=0.010
  • Median OS: 24 vs. 21.3 mos,HR:0.62, p=0.181
Safety:
  • Any grade AEs: fatigue (9 vs.13%), nausea (7 vs. 4%), pruritus (4 vs. 0%)
  • Grade≥3 AEs: peripheral edema (2 vs. 0%)

J Clin Oncol 2023; 10 FEB

Gillessen S. et al. ¨ Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)¨

https://doi.org/10.1200/JCO.22.01726

Reviewed by Elvin CHALABİYEV, MD on FEB 24, 2023

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