Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE: JNJ) announced the results of a landmark real-world, head-to-head study showing that ERLEADA® (apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). Presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal, on October 2 (Abstract #P31), this study of nearly 4,000 patients represents the largest real-world, head-to-head analysis of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC.
The study applied U.S. Food and Drug Administration (FDA) real-world evidence guidance and employed robust methodology, data sources and a large, diverse cohort to ensure validity of its findings. The retrospective study identified mCSPC patients who initiated ERLEADA® or enzalutamide between December 16, 2018 – December 31, 2023, based on patient data in electronic databases. There were 1,800 ERLEADA® and 1,909 enzalutamide initiators who met study criteria.
The analysis demonstrated patients with mCSPC who initiated ERLEADA® as their first ARPI had a statistically significant 23 percent reduction in their risk of death at 24 months compared to patients who initiated on enzalutamide (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62-0.96; P<0.019). The proportion of patients alive at 24 months (87.6 percent) observed in the ERLEADA® cohort in this real-world analysis is consistent with that in the Phase 3 TITAN trial (82.4 percent).1 TITAN demonstrated a statistically significant superior overall survival benefit of ERLEADA® plus androgen deprivation therapy (ADT) compared to ADT alone at the primary analysis after a median 22.7 months of follow-up (HR 0.67; 95% CI, 0.51-0.89; P=0.005) and at the final analysis after a median 44 months of follow-up (HR 0.65; 95% CI, 0.53-0.79; P<0.0001).1,2
“This real-world evidence showed a statistically significant and clinically meaningful improvement in survival with apalutamide over enzalutamide in patients with mCSPC at 24 months,” said Neal Shore, M.D., F.A.C.S., Steering Committee Chair and Medical Director, Carolina Urologic Research Center and study investigator.* “Head-to-head, randomized and controlled Phase 3 studies have been the gold standard for comparing the effectiveness of oncology medicines, however, prospective ARPI comparator trials have not been conducted. This real-world study is provocative as the comprehensive data and rigorous methodology used in this study offers real-world insights on overall survival which can provide prescribers with information to consider when choosing an ARPI.”
“ERLEADA is the only ARPI to demonstrate a survival benefit as early as 22 months, as seen in the TITAN study. Since ERLEADA’s approval, multiple ARPIs have been introduced, but no one has directly compared their effectiveness on a large scale – until now,” said Luca Dezzani, M.D., U.S. Vice President, Medical Affairs, Solid Tumors, Johnson & Johnson Innovative Medicine. “With a decade-plus legacy in prostate cancer, we have pushed the field further with this additional evidence showing an overall survival benefit with ERLEADA, which is a patient-centric option taken as just one pill, once daily.”
Some limitations of this study include potential miscoding or missing information in the data sources; however, the data sources used in this study were deemed fit for purpose to identify the patient population correctly and to assess survival. Lastly, while survival was assessed at 24 months for statistical comparison, longer-term studies are needed to fully evaluate the therapeutic effects of these treatments.
- Chi KN, Agarwal, N, Bjartell, A, et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019;381(1):13-24. doi: 10.1056/NEJMoa1903307
- Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J Clin Oncol. 2021;39(20):2294-2303. doi: 10.1200/JCO.20.03488