Potential Metastatic Prostate Cancer Therapy Achieves Primary Trial Endpoints

If approved, apalutamide (Erleada) plus androgen deprivation therapy would offer an additional treatment option for patients with metastatic castration-sensitive prostate cancer.

Janssen’s apalutamide (Erleada) met its dual primary endpoints in the phase 3 TITAN study evaluating the drug in metastatic castration-sensitive prostate cancer (mCSPC), according to a press release.

Following a pre-planned analysis, the trial has been unblinded based on a recommendation from an Independent Data Monitoring Committee (IDMC).

The double-blind study includes more than 1050 patients with mCSPC who were randomized to receive either apalutamide plus androgen deprivation therapy (ADT) or placebo plus ADT. Patients were treated until disease progression, the occurrence of unacceptable treatment-related toxicity, or end of treatment.

According to the analysis, apalutamide plus ADT significantly improved radiographic progression-free survival and overall survival, achieving the trial’s primary endpoints. Secondary endpoints included time to chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal related event.

Based on these results, the IDMC recommended that patients in the placebo plus ADT group be given the opportunity to cross over to treatment with apalutamide plus ADT.

Apalutamide, an androgen receptor inhibitor, was first approved for the treatment for non-metastatic CSPC in February 2018, making it the first therapy approved for this disease state. The drug is included as a category 1 recommendation in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Prostate Cancer for this indication, according to Janssen.

“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,” Margaret Yu, MD, vice president of Oncology Clinical Development, Janssen Research and Development, said in a statement. “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.”

Regulatory applications seeking approval for apalutamide plus ADT in this indication are expected this year, according to the press release.

Reference

Janssen Announces ERLEADA (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer [news release]. Johnson & Johnson. https://www.jnj.com/janssen-announces-erleada-apalutamide-phase-3-titan-study-unblinded-as-dual-primary-endpoints-achieved-in-clinical-program-evaluating-treatment-of-patients-with-metastatic-castration-sensitive-prostate-cancer. Accessed January 30, 2019.