Addition of apalutamide to androgen deprivation therapy prolongs survival in metastatic prostate cancer - Healio

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A randomized phase 3 trial designed to evaluate the addition of apalutamide to androgen deprivation therapy for men with metastatic castration-sensitive prostate cancer has been unblinded at the recommendation of an independent data monitoring committee.

The committee made its recommendation after a preplanned analysis showed the TITAN study met its dual primary endpoints, demonstrating significantly improved radiographic PFS and OS among men assigned apalutamide (Erleada, Janssen) plus ADT compared with those assigned placebo plus ADT.

The committee’s recommendation allows men assigned placebo plus ADT to cross over to treatment with apalutamide plus ADT. Follow-up for OS and long-term safety will continue.

Apalutamide — an androgen receptor inhibitor — is approved for treatment of nonmetastatic castration-resistant prostate cancer.

“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,” Margaret Yu, MD, vice president of oncology clinical development for Janssen Research & Development LLC, said in a company-issued press release.

The double-blind TITAN study included more than 1,050 men newly diagnosed with metastatic disease. Researchers enrolled study participants regardless of prognostic risk, volume of disease, prior treatment with docetaxel or treatment of localized disease.

Investigators randomly assigned men to ADT plus apalutamide or placebo. Men received their assigned regimen until disease progression, unacceptable treatment-related toxicity or conclusion of treatment.

Radiographic PFS and OS served as dual primary endpoints. Secondary endpoints included time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.

Results from the TITAN study will be submitted for presentation at a future medical congress.

Data from TITAN will be included in applications for regulatory approval of apalutamide. Those applications will be submitted later this year, according to the release.



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