The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the use of apalutamide.
The CHMP’s positive opinion is based on data from the pivotal SPARTAN Phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT).
The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001).
The median MFS was improved by over two years (40.5 months vs 16.2 months) in patients with nmCRPC whose PSA is rapidly rising.
This study was published in The New England Journal of Medicine.
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent).
Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm.
Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).
“Data from the SPARTAN study showed that apalutamide significantly improves metastasis free survival for patients with castration-resistant prostate cancer,” said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St Thomas' Hospitals. “Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases. At that point their prognosis worsens dramatically. Delaying the spread of cancer is therefore critical for patients living with prostate cancer.”
“We are pleased with the CHMP’s decision to recommend approval of apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer,” said Dr. Ivo Winiger-Candolfi M.D., Janssen Oncology Solid Tumor Therapy Area Lead, Europe, Middle East and Africa, Cilag GmbH International. “We know that each prostate cancer patient journey is unique and today’s positive CHMP opinion brings us one step closer to offering patients an effective treatment option that delays the spread of their disease.”