Janssen Announces Treatment with Apalutamide Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer

Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease

San Francisco, CA (UroToday.com) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.1 Results will be featured in an oral presentation at the American Society of Clinical Oncology's Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #11; Rapid Abstract Session: Prostate Cancer, February 11, 3:30 PM-4:15 PM EST).

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001).1 The results were similar to the primary analysis of TITAN despite the subsequent crossover rate of almost 40 percent of the placebo-controlled group to the ERLEADA® arm. The improvement in OS increased to a 48 percent reduction in risk of death after adjusting for patients who crossed over (HR 0.52; p<0.0001).1

"The TITAN final analysis further confirms that treatment with apalutamide can prolong overall survival and offer a clear long-term clinical benefit and established safety profile for patients with metastatic prostate cancer who are starting androgen deprivation therapy," said Dr. Kim Chi, Medical Oncologist at BC Cancer - Vancouver and principal investigator of the TITAN study. "Based on these data, ADT alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease."
There was consistent benefit across other endpoints, including improved second progression-free survival (PFS2) (HR 0.62; p<0.0001) and delayed castration resistance (HR 0.34; p<0.0001). In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA®. Safety and tolerability of ERLEADA® was consistent with previously reported studies.1

"The TITAN final analysis data confirm the long-term clinical benefit and consistent safety profile of ERLEADA® plus ADT without a compromise in health-related quality of life," said Mary Guckert, RN, MSN, Vice President, Development Leader, Prostate Cancer, Janssen Research & Development, LLC. "The results show the consistency and durability of ERLEADA® across advanced prostate cancer and underscore how ERLEADA® can fulfill a critical need."

Initial results from the TITAN study presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine showed the addition of ERLEADA® (apalutamide) to ADT compared to placebo plus ADT significantly improved the dual primary endpoints of OS and radiographic progression-free survival (rPFS) in patients with mCSPC.2 

To date, published results on ERLEADA® include data from more than 2,000 patients across Phase 3 clinical studies. ERLEADA® has shown a statistically significant improvement in OS with a consistent safety profile in both approved indications of mCSPC (TITAN) and non-metastatic castration-resistant prostate cancer or nmCRPC (SPARTAN).2 ERLEADA® is currently approved in more than 74 countries, and labels are being updated globally to reflect these data from the TITAN final analysis.


  1. Chi, K. Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide (APA) vs Placebo (PBO) in Patients (pts) With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Receiving Androgen Deprivation Therapy (ADT). ASCO GU 2021 Oral Presentation.
  2. ERLEADA®Prescribing Information, September 17, 2019.

Source: Janssen. 2021. Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer.