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Final TITAN trial results favour use of apalutamide

Presented by
Dr Kim Chi, British Columbia Cancer and Vancouver Prostate Centre, Canada
ASCO GU 2021
Phase 3, TITAN
Apalutamide plus androgen deprivation therapy (ADT) in men with metastatic castration-sensitive prostate cancer (mCSPC) demonstrated improved overall survival (OS) and reduced risk of death compared with placebo.

The phase 3, randomised, placebo-controlled, double-blind TITAN trial (NCT02489318) investigated whether the addition of apalutamide to ADT would improve radiographic progression-free survival (rPFS) or OS in men with mCSPC [1]. Of the 1,052 participants, 525 received apalutamide, while 527 received a placebo. Investigators performed their first interim analysis after a median follow-up period of 22.7 months. At that time, both OS and rPFS were significantly better in the apalutamide group (OS, HR=0.67; rPFS, HR=0.48) than in the placebo group.

This analysis coincided with the unblinding of TITAN, giving patients from the placebo arm the opportunity to proceed to the open-label extension phase of the trial. Of the 527 patients in the placebo arm, 208 (39.5%) chose to cross over to receive apalutamide. Dr Kim Chi (British Columbia Cancer and Vancouver Prostate Centre, Canada) presented the TITAN results following the crossover, after nearly 4 years of follow-up.

The crossover group underwent treatment for a median duration of 15.4 months, as compared with a median treatment duration of 39.3 months for the apalutamide group, and 20.2 months for the placebo group as a whole.

Final analyses continue to show superior OS outcomes in the apalutamide group; 48-month survival rates were 65% in the apalutamide group versus 52% in the placebo group. This corresponded to a 35% reduction in the risk of death, which became a 48% reduction of death risk with the inclusion of the crossover patients. Health-related quality of life outcomes did not differ between groups, and the safety profile was consistent with that reported previously. Dr Chi concluded that these final results from TITAN support the use of apalutamide in men with mCSPC.

  1. Chi K. Final analysis results from TITAN: A phase¬†III study of apalutamide versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). Abstract 11, ASCO Genitourinary Cancers Symposium, 11‚Äď13 February 2021.


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