Adding Janssen‘s androgen receptor inhibitor Erleada (apalutamide) to first-line androgen deprivation therapy (ADT) significantly extended survival and delayed disease progression or death in metastatic castration-sensitive prostate cancer patients included in a Phase 3 trial — meeting the study’s two primary objectives.
Based on the findings, an independent data monitoring committee has recommended that the TITAN trial be unblinded — so both patients and physicians know who is getting which treatment — and that patients on only ADT be given the chance to cross over to the active treatment.
“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 at Janssen research and development, said in a press release.
Metastasis is a major cause of complications and death among men with prostate cancer. Once prostate cancer spreads, patients tend to have a poor prognosis, even if their cancer still responds to hormone therapy — termed castration-sensitive prostate cancer (CSPC).
Erleada is an oral agent that prevents the binding of testosterone to the androgen receptor, blocking signals that prostate cancer cells require to grow and proliferate. It is already approved in the U.S. and Europe for preventing metastasis in men with castration-resistant prostate cancer.
The Phase 3 TITAN trial (NCT02489318) was designed to investigate if adding Erleada to standard ADT could improve the outcomes of metastatic CSPC patients — particularly in extending their overall survival and the time they live without disease worsening — compared with ADT alone.
Secondary measures included time to chemotherapy, time to worsening of pain, time to opioid use, and time to skeletal-related event, including fractures, bone metastasis, or spinal cord compression.
TITAN includes more than 1,050 patients, regardless of their prognostic risk, prior treatment with Taxotere (docetaxel), or treatment for localized disease (before the cancer had spread). Patients were randomly allocated to once-daily, oral Erleada plus ADT, or a placebo plus ADT.
Treatment is continued until patients experienced disease progression or unacceptable toxicity.
While the trial’s main goals have been achieved, final results from TITAN have not yet been disclosed. Researchers will continue to follow patients in the trial for overall survival and long-term safety results. They hope to present the data at an upcoming medical meeting and to submit the findings for regulatory approval of Erleada this year.
“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,” Yu said.