Results from the second interim analysis of the phase III SPARTAN study featured in an oral presentation at ESMO 2019. Janssen Pharmaceuticals

The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated, longer-term results from the pivotal Phase III 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. 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. 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. 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<0.0121 needed to be observed. the os benefit of erleada was consistent across baseline subgroups such as race prior treatments baseline psa and performance status. 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)." 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.>

The rates of treatment-emergent adverse events for Erleada at the second interim analysis were consistent with rates previously reported. In the SPARTAN study, the most common adverse events ( greater than 10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.

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.

See-"Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer ".- E J Small, F Saad, S Chowdhury, S Oudard, B A Hadaschik,et,al. Annals of Oncology, mdz397, https://doi.org/10.1093/annonc/mdz397 Published: 27 September 2019.