A US Independent Data Monitoring Committee has recommended that patients in the placebo group of Johnson & Johnson subsidiary Janssen’s Phase III TITAN trial of Erleada (apalutamide) plus androgen deprivation therapy (ADT) indicated for metastatic castration-sensitive prostate cancer (mCSPC) could switch to the drug group.
This recommendation was based upon data showing Erleada plus ADT met both its co-primary endpoints – improving radiographic progression-free survival (rPFS) and overall survival (OS).
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The TITAN trial, which is a multi-centred, randomised study with 1,050 participants, will continue to monitor OS and long-term safety of the drug plus ADT in mCSPC patients. Janssen expects to file for regulatory approval for this indication later in 2019.
Janssen research and development vice-president of oncology clinical development Margaret Yu said: “The TITAN study was designed to evaluate the efficacy and safety of ERLEADA in combination with androgen deprivation therapy in patients with newly-diagnosed metastatic castration-sensitive prostate cancer, regardless of the extent of their disease.
“We look to continue to build upon our understanding of Erleada for patients with metastatic prostate cancer as there remains a significant unmet need for additional treatment options.”
Erleada, which is an androgen, or male hormone, receptor, was approved in February 2018 for non-metastatic castration-resistant prostate cancer (nmCRPC), making it the first US Food and Drug Administration (FDA) approved therapy for this indication.
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By GlobalDataThis approval was based upon Janssen’s Phase III SPARTAN study and followed an earlier FDA priority review designation. The company’s global head of research and development Mathai Mammen said: “We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer.”
The European Medicines Agency Committee for Medicinal Products for Human Use adopted a positive opinion of Erleada for nmCRPC in November 2018. The drug is awaiting approval by the European Commission.
