FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer

The FDA has approved darolutamide (Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).¹

Approval was based on the findings from the phase 3 ARASENS trial (NCT02799602), in which darolutamide plus docetaxel improved median overall survival (OS) when compared with docetaxel alone.

Results showed that the median OS with darolutamide/docetaxel was not yet reached (95% CI, NR-NR) vs 48.9 months (95% CI, 44.4-NR) with docetaxel alone (HR 0.68; 95% CI, 0.57-0.80; P <.0001). Additionally, treatment with darolutamide and docetaxel significantly delayed time-to-pain progression (HR 0.79; 95% CI, 0.66-0.95; 1-sided P =.006).

In the randomized, multicenter, double-blind, placebo-controlled ARASENS clinical trial, a total of 1306 patients with mHSPC were enrolled. Patients were randomly assigned to receive oral darolutamide at 600 mg twice daily in combination with intravenous docetaxel at 75 mg/m2 every 3 weeks for up to 6 cycles or docetaxel alone. Those enrolled were given gonadotropin-releasing hormone analog concurrently or underwent a bilateral orchiectomy.

The primary end point of the trial was OS with time-to-pain progression serving as an additional efficacy measure.

The median age for patients enrolled was 67 years (range, 41-89) with 17% of patients 75 years of age or older. Fifty-two percent of patients were White, 36% were Asian, 4% were Black or African American, and 7% were Hispanic/Latino. Additionally, 3% of patients had M1a disease, 83% had M1b, and 14% had M1c.

In regard to safety, the most common adverse events reported were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase, increased alanine transaminase, and hypocalcemia.

The recommended dose of darolutamide for mHSPC is 600 mg consisting of 2 300 mg tablets taken orally, twice a day until unacceptable toxicity or disease progression. Additionally, docetaxel is recommended to be administered intravenously at 75 mg/m2 every 3 weeks for up to 6 cycles. The first dose of docetaxel should be administered within 6 weeks after the start of darolutamide treatment.

Reference:

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. News release. FDA. August 5, 2022. Accessed August 5, 2022. https://bit.ly/3vM1dAH