Final Analysis Results From the Phase 3 TITAN Study

Kim N. Chi, MD, presents slides from the 2021 ASCO Genitourinary Cancers Symposium for the final results from the phase 3 TITAN study of apalutamide versus placebo in patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy.

Kim N. Chi, MD, discusses data from the following presentation:

• Final analysis results from TITAN: a phase 3 study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). (Chi, ASCO GU 2021, Abstract 11)
  • The TITAN study (NCT02489318) is an international, randomized, double-blinded, placebo-controlled, phase 3 study.
  • The final analysis of TITAN, after a median follow-up of approximately 4 years, confirmed that APA+ADT consistently improved OS, with a reduced risk of death by 35% (HR, 0.65; 95% CI, 0.53-0.79) compared with PBO+ADT in a broad population of patients with mCSPC.
  • After adjustment for almost 40% of PBO patients who crossed over to receive APA, the risk of death was reduced by 48% (HR, 0.52; 95% CI, 0.42-0.64).
  • APA provided a consistent benefit in other end points, including delayed castration resistance and maintained health-related quality of life, with an acceptable safety profile and no new safety signals.