The first results from the Phase III TITAN study presented on Friday showed that Johnson & Johnson's Erleada (apalutamide) significantly improved overall survival (OS), with a 33-percent reduction in the risk of death, versus placebo in patients with metastatic castration-sensitive prostate cancer (mCSPC). The data were detailed at the American Society of Clinical Oncology (ASCO) annual meeting.
In January, Johnson & Johnson announced that the trial met its primary endpoints, with the Independent Data Monitoring Committee recommending that based on the findings, patients in the placebo arm be allowed to cross over to the Erleada arm. The company subsequently submitted an application to the FDA seeking expanded approval of the androgen receptor inhibitor to include the treatment of patients with mCSPC, with the agency reviewing the filing under its Real-Time Oncology Review programme.
In the TITAN study, 1052 patients with mCSPC were randomly assigned to treatment with Erleada or placebo, both in combination with androgen deprivation therapy (ADT). The primary endpoints of the study were radiographic progression-free survival (rPFS) and OS, while secondary goals include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.
Results presented at ASCO showed that the two-year OS rates, after a median follow-up of 22.7 months, were 82 percent for Erleada compared to 74 percent for placebo, while median OS has not been reached in either arm of the study. In addition, Erleada significantly improved rPFS, with a 52-percent reduction in risk of death or radiographic progression, with the benefit seen across all subgroups. Johnson & Johnson added that median rPFS has not been reached in the Erleada arm, while it is 22.1 months in the placebo group.
Further results showed that the secondary endpoint of prolonged time to cytotoxic chemotherapy was also met, with a 61-percent risk reduction for Erleada compared to placebo. Additionally, median time to PSA progression was "more favourable" following treatment with Erleada, while PSA reached undetectable levels in 68 percent of those in the Erleada arma, versus 29 percent in the placebo group. However, Johnson & Johnson noted that time to pain progression did not reach statistical significance.
Craig Tendler, vice president of clinical development and global medical affairs, oncology, at Johnson & Johnson's Janssen Research & Development unit, said "these data suggest that ADT alone should no longer be considered the standard of care for metastatic castration-sensitive prostate cancer and support…investigation of Erleada in earlier stages of prostate cancer."
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