Patients treated with Nubeqa were less likely to develop disease metastasis or discontinue treatment 6 to 18 months after ARI course start compared to Xtandi or Erleada, according to data presented at ASCO GU.
Patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were treated with Nubeqa (darolutamide) were approximately 15% less likely to develop metastatic disease (cancer in a different spot than the initial tumor) or discontinue treatment due to side effects than patients treated with Xtandi (enzalutamide) or Erleada (apalutamide), according to research presented at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium.
The DEAR study analyzed the three second-generation androgen receptor inhibitors (the current standard of care for nmCRPC) to compare real-world drug utilization and examine side effects, the leading cause of treatment discontinuation for this type of drug. The three drugs included are currently the only androgen receptor inhibitors (ARIs) on the market.
Researchers reviewed patient charts from 66 patients with nmCRPC: 276 were treated with Nubeqa, 280 with Xtandi and 110 with Erleada.
Of patients treated with Nubeqa, 35.9% developed metastatic disease or discontinued treatment, as opposed to 52.1% with Xtandi and 50.9% with Erleada patients. Favorable Nubeqa results began within six months of treatment, with 15.2% of patients developing metastatic disease, compared with 27.9% and 23.6% in the Xtandi and Erleada groups, respectively. At 18 months 31.2%, 45% and 44.5% in the Nubeqa, Xtandi and Erleada groups, respectively, experienced metastasis.
The most common reason for discontinuation was side effects, at 8.3% in the Nubeqa group, 15% in the Xtandi group and 12.7% in the Erleada group. Metastasis occurred in 14.9% Nubeqa, 22.9% Xtandi and 18.2% Erleada patients. Death occurred in 3.3%, 5.4% and 2.7%, respectively. Median time to endpoint (discontinuation or disease metastasis) was 33.4 months for Nubeqa, 20.8 for Xtandi and 18.5 for Erleada.
Median patient age, and prostate-specific androgen, a hormone indicating prostate cancer disease progression, doubling time were similar across all groups at the start of the trial. Eligible patients were diagnosed with nmCRPC, began ARI therapy between August 2019 and March 2022 and had not previously been treated with any novel hormone therapies.
Study authors posit the favorable outcomes in Nubeqa patients may be attributed “to (Nubeqa) being a structurally distinct ARI with low potential for blood–brain barrier penetration,” according to the abstract.
“The real-world evidence study reinforces the favorable safety profile of (Nubeqa) in the ARAMIS study population. It further demonstrates the importance of treatment tolerability and the potential for longer treatment duration with (Nubeqa) compared to (Xtandi) and (Erleada) which may in turn improve treatment outcomes,” presenter Daniel George concluded.
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