Erleada reduced the risk of death by more than 20% compared with other treatments in metastatic castration-sensitive prostate cancer.
Among patients with metastatic castration-sensitive prostate cancer, treatment with Erleada (apalutamide) showed consistent 24-month overall survival between real-world use and the phase 3 TITAN trial.
These findings were presented at the 50th Annual Oncology Nursing Society Congress. Data reported showed that at 24 months after treatment initiation, patients with metastatic castration-sensitive prostate cancer who were not previously treated with androgen receptor pathway inhibitors (ARPIs) and received Erleada showed a 23% reduction in the risk of death compared with patients treated with Xtandi (enzalutamide); this overall survival result was also consistent when using all available follow-up. Patients treated with Erleada after 24 months post-index had a 26% reduction in the risk of death versus patients treated with Zytiga (acetate); this overall survival result was also consistent when using all available follow-up.
“All three agents have demonstrated statistically significant reductions in disease progression and death as compared with androgen deprivation therapy [ADT] alone in patients with metastatic castration-sensitive prostate cancer in phase 3 trials,” said Kelly Hastings, senior medical science liaison at Johnson & Johnson Innovative Medicine, in a poster presentation of the findings. “However, there are currently no head-to-head studies comparing the survival outcomes [or disease progression] between Erleada and either of the two agents in ARPI-naive patients with metastatic castration-sensitive prostate cancer.”
Androgen receptor pathway inhibitors (ARPI): drugs that block the effects of male hormones on prostate cancer cells, helping slow cancer growth.
Median overall survival (OS): the midpoint survival time where half of patients live longer and half live shorter.
Radiographic progression: worsening of cancer visible on imaging tests like X-rays or CT scans.
In September 2019, the United States Food and Drug Administration (FDA) approved Erleada for the treatment of patients with metastatic castration-sensitive prostate cancer, which was based on data from the phase 3 TITAN trial. Results from the final analysis revealed that Erleada plus ADT led to a 35% reduction in the risk of death compared with placebo plus ADT, with a median overall survival that was not reached versus 52.2 months, respectively.
In December 2019, the FDA approved Xtandi for the treatment of patients with metastatic castration-sensitive prostate cancer, which was based on findings from the phase 3 ARCHES trial. Of note, Xtandi plus ADT significantly reduced the risk of radiographic progression or death versus placebo plus ADT. Moreover, the FDA approved Zytiga with prednisone for high-risk metastatic castration-sensitive prostate cancer in February 2018 based on findings from the phase 3 LATITUDE trial. In the final overall survival analysis of the study, the median OS was significantly longer in the Zytiga cohort at 53.3 months versus 36.5 months in the placebo cohort.
In the Erleada versus Xtandi analysis, the median follow-up period was 20.1 months in those who initiated Erleada and Xtandi, respectively. Of note, the median duration of continuous ARPI use, with a 90-day gap between treatments to define discontinuation, was 6.9 months in the Erleada cohort and 6.4 months in the Xtandi cohort.
Based on the Erleada versus Zytiga analysis, the median follow-up period was 19.5 months in patients who initiated Erleada and 19 months in those who initiated Zytiga. Specifically, the median duration of continuous ARPI use, including the 90-day gap in treatments to define discontinuation, was 6.6 months versus 8.9 months in those who initiated Erleada or Zytiga, respectively.
Limitations of this real-world study included the potential for selection and information bias because of miscoding or misclassification in clinical records or claims data, a sole database reflection of a community urology perspective, missing deaths from KRD despite high capture rates of 90% or greater, residual differences post-IPTW associated with a high-risk indication for Zytiga, and the confinement that the regression analysis could only adjust for measured covariates with the potential of remaining confounding variables.
“In phase 3 trials, overall survival was assessed at prespecified time points. In these real-world studies, overall survival was assessed [for] 24 months for evaluation of statistical comparison. Longer follow-up may better estimate the full clinical benefit of Erleada,” the poster authors concluded.
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