Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer.

Egils Vjaters, Karim Fizazi, Nicholas D. James, Teuvo Tammela, Nobuaki Matsubara, Frank Priou, Thierry Lesimple, Petri Bono, Vesa V. Kataja, Jorge A. Garcia, Andrew Protheroe, John Aspegren, Heikki Joensuu, Iris Kuss, Silke Thiele, Sabine Fiala-Buskies, Robert Hugh Jones

Research output: Contribution to journalMeeting Abstractpeer-review


90Background: Darolutamide, a structurally distinct and highly potent androgen receptor inhibitor, had a consistently favorable safety and tolerability profile in patients with nonmetastatic castration-resistant prostate cancer in ARAMIS, and discontinuation rates due to adverse events (AEs) remained consistently low after longer follow-up. In previously reported phase 1/2 studies in patients with metastatic castration-resistant prostate cancer (mCRPC), darolutamide was well tolerated for up to 25 months. We report the safety and tolerability of extended treatment with darolutamide in these mCRPC studies. Methods: Data from three phase 1/2 studies (NCT02363855, NCT01317641/NCT01429064, and NCT01784757) in patients with mCRPC were pooled for analysis of long-term safety. Results are summarized descriptively. Results: Of 173 patients with mCRPC evaluable for safety in the 3 studies, 13 patients received > 2 years of darolutamide treatment; median duration of treatment was 38 months (range 24–90). Six patients received > 4 years of darolutamide treatment. Nine of 13 patients with > 2 years of darolutamide therapy initially received 600 mg BID; others received 200 mg (n = 1), 300 mg (n = 1), or 700 mg (n = 2) BID. Median age was 68 years in the > 2-years group, and most patients were white. Patients were enrolled from France (n = 4), Latvia (n = 3), United Kingdom (n = 3), Finland (n = 2), and Japan (n = 1). Most patients had normal renal function (n = 10) and hepatic function (n = 10), 12 patients had Eastern Cooperative Oncology Group performance status of 0, and 9 patients had a Gleason score ≥7. Prior systemic anticancer treatments taken by more than 1 patient were bicalutamide (n = 10); cyproterone (n = 3); and triptorelin and leuprorelin (n = 2 each). No patient received prior chemotherapy. All 13 patients reported AEs, most grade 1 or 2; 6 reported grade 3 AEs. Treatment-related AEs were reported in 5 patients, and all were grade 1 in severity. Serious AEs were reported in 6 patients, and all were judged not related to darolutamide. One patient treated with darolutamide for > 2 years had an AE (new neoplasm; not related to darolutamide) that led to treatment discontinuation. Conclusions: Extended darolutamide treatment > 2 years in this small group of patients with mCRPC was generally well tolerated, with safety and tolerability consistent with that previously reported. Clinical trial information: NCT02363855, NCT01317641/NCT01429064, and NCT01784757.
Original languageEnglish
Pages (from-to)90-90
Number of pages1
JournalJournal of Clinical Oncology
Issue number6 suppl.
Publication statusPublished - 20 Feb 2022
Externally publishedYes
EventASCO (American Society of Clinical Oncology) Genitourinary Cancers Symposium - Moscone West, San Francisco, CA/ and Online, San Francisco, United States
Duration: 17 Feb 202219 Feb 2022

Field of Science*

  • 3.2 Clinical medicine
  • 3.1 Basic medicine

Publication Type*

  • 3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database


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