San Francisco, CA (UroToday.com) — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated, longer-term results from the pivotal Phase 3 SPARTAN study following a second interim analysis. Treatment with ERLEADA® (apalutamide) plus androgen deprivation therapy (ADT) resulted in a 25 percent reduction in the risk of death compared with placebo plus ADT in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1
Results from the second interim analysis of the Phase 3 SPARTAN study featured in an oral presentation at ESMO 2019 and simultaneously published in Annals of Oncology
The updated findings showed overall survival (OS) results supported the first interim analysis, despite a crossover of patients receiving placebo to the ERLEADA® treatment group.1 Results were presented in an oral session at the 2019 European Society for Medical Oncology (ESMO) Annual Congress (abstract #843O), and simultaneously published in Annals of Oncology.
At the second interim analysis, a longer median follow-up of 41 months, four-year OS rates were 72.1 percent for patients treated with ERLEADA® and 64.7 percent for patients treated with placebo.1 Overall, a 25 percent reduction in the risk of death was observed for patients receiving ERLEADA® compared with placebo [HR=0.75; 95 percent CI, 0.59-0.96; p=0.0197 (to reach statistical significance, a p-value of p
This interim analysis took place when 67 percent of the required OS events had been observed, compared with the original report when only 24 percent of required OS events had occurred (HR=0.70; 95 percent CI, 0.47-1.04; p=0.07).1 After unblinding the study and prior to the second interim analysis, 76 non-progressing patients in the placebo group (19 percent of all placebo patients) crossed over to open-label ERLEADA®; the OS rates in the placebo group included those patients who were crossed over to ERLEADA® treatment.1 The rates of treatment-emergent adverse events for ERLEADA® at the second interim analysis were consistent with rates previously reported.1 In the SPARTAN study, the most common adverse events (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.2
“Longer-term analyses help to present a more complete picture of a medication’s benefits and potential risks over time. This updated SPARTAN analysis shows an important survival benefit,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School, and co-principal investigator of the SPARTAN study. “These results add to the evidence supporting apalutamide as a standard option for treating patients with non-metastatic castration-resistant prostate cancer who remain at high risk of their cancer spreading.”
Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine.
“While there have been advances in the treatment of prostate cancer over the years, it is still a lethal illness, particularly when patients progress to later stages of metastatic disease,” said Margaret Yu, M.D., Vice President, Prostate Cancer Disease Area Leader, Janssen Research & Development, LLC. “ERLEADA® is now being studied in five Phase 3 randomized controlled trials as part of the largest clinical program of androgen receptor inhibitors. Together, these trials highlight Janssen’s commitment to making prostate cancer a manageable disease.”
About the SPARTAN Study SPARTAN (NCT01946204) was a Phase 3, randomized, registrational, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA® in combination with ADT in men with nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).2 The SPARTAN study enrolled 1,207 patients who were randomized 2:1 to receive either ERLEADA® orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401). Study results were initially reported at the 2018 ASCO Genitourinary Cancers Symposium and published in The New England Journal of Medicine.
Warnings and Precautions include ischemic cardiovascular events, fractures, falls, seizure and embryo-fetal toxicity.2 In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.2
- Smith, M, et al. Apalutamide and Overall Survival in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): Updated Results from the Phase 3 SPARTAN Study. Accessed September 2019.
- ERLEADA® Prescribing Information, September 2019.
Johnson, Janssen. 2019. “Updated Results of the SPARTAN Study Show 25 Percent Reduction in the Risk of Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) Treated with ERLEADA® (apalutamide)”. Prnewswire.com.
Further Related Content:
Abstract: Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer