Janssen’s Erleada combo smashes endpoints in advanced hormone-sensitive prostate cancer

pharmafile | June 3, 2019 | News story | Research and Development, Sales and Marketing ASCO 2019, Cancer, Erleada, Janssen, prostate cancer 

Janssen joined the showing at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago to present new data for its androgen receptor (AR) inhibitor Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC)

The company revealed that use of the combination “significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS)”. In a study of 1,052 participants, which included mHSPC patients regardless of extent of disease or prior docetaxel treatment history, the therapy extended OS by 33% compared to placebo plus ADT, while rPFS was improved by 52%.

Median OS was not reached in either arm, while median rPFS stood at 22.1 months for placebo plus ADT, but was not reached in the Erleada plus ADT group. The Erleada therapy also met its secondary endpoint, prolonging time to cytotoxic chemotherapy by 61% compared to placebo plus ADT.

“The data presented today mark a major scientific evidence milestone in the management of patients with mHSPC,” said Professor Axel S Merseburger, Chairman of the Department of Urology at Campus Lübeck, University Hospital Schleswig-Holstein. “The TITAN data has shown that apalutamide could significantly benefit patients by delaying disease progression and critically, prolong overall survival in a disease where median overall survival is less than five years. It is clinically relevant to see that this trial has demonstrated that apalutamide has the potential to benefit all types of patients with mHSPC and I am incredibly proud to be a part of this study.”

Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, added: “This is the first presentation of the investigational TITAN data. We are encouraged that apalutamide significantly improved overall survival and in a relevant magnitude, underscoring that the efficacy of treatment with ADT alone could offer to patients with mHSPC was, actually, inferior to that provided by apalutamide.”

Matt Fellows

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