Discussing his presentation from the 2023 ASCO Genitourinary Symposium, Neal Shore, MD, FACS, looks at the long-term results of the phase 3 ARAMIS study for patients with nonmetastatic castration-resistant prostate cancer on darolutamide.
Neal Shore, MD, FACS, the US chief medical officer of Surgery and Oncology at GenesisCare and the director and certified principal investigator at the Carolina Urologic Research Center, discusses the long-term results of the phase 3 ARAMIS trial (NCT02200614).
Presented at the 2023 Genitourinary Cancers Symposium, the long-term results of the trial showed that darolutamide (Nubeqa) maintained its safety profile and clinical benefit for patients with nonmetastatic castration-resistant prostate cancer (CRPC). The ARAMIS trial was a double-blind (DB), randomized, multicenter study with an open-label (OL) rollover study (ROS) (NCT04464226) that looked at 954 patients who started darolutamide on randomization. Then, 294 (31%) patients entered the ROS.
By the data cutoff date of January 31, 2023, 30% of patients had received darolutamide for at least 4 years, and 24% were still receiving darolutamide at the time of the presentation. The long-term resultsshowed that incidence of treatment-emergent adverse events (TEAEs) increased slightly over time, but this was expected with a longer observation time, according to the researchers.
In the DB, DB and OL, and DB/OL/ROS periods, 85.7%, 89.8%, and 91.5% of patients experienced any-grade TEAEs, respectively. Moreover, 26.3%, 31.8%, and 35.5% of patients in the DB, DB and OL, and DB/OL/ROS periods, respectively, experienced a grade 3/4 TEAE, and 26.1%, 32.1%, and 38.5% of patients, experienced a serious TEAE, respectively. The researchers did not identify any new safety concerns, and 8.9%, 10.5%, and 12.9% of patients experienced a TEAE leading to treatment discontinuation in the DB, DB and OL, and DB/OL/ROS periods, respectively.
In a primary analysis of the original ARAMIS study, darolutamide significantly improved metastasis-free survival and reduce the risk of death vs placebo, with a permanent discontinuation due to AEs in the darolutamide group (8.9%) and placebo group (8.7%).
Shore discusses how these main findings change the outlook of how this treatment can impact patients with nonmetastatic CRPC.
0:08: The main findings were that the clinical benefit and the favorable safety profile of darolutamide for [patients with] nonmetastatic CRPC has now been maintained for several years. The treatment emergent adverse events, that we have a list of through careful trial definitions, were essentially consistent in terms of any grade, grade 3/4, and even the issues regarding discontinuation that were treatment-related. The data that we presented, [showed that the AEs] slightly increased over time, as what would be expected, but the difference in the increase is very, very small.