Janssen Announces ERLEADA® (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer

Phase 3 Study Unblinded Following Recommendation of Independent Data Monitoring Committee

SPRING HOUSE, PA, USA I January 30, 2019 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the unblinding of the Phase 3 TITAN study evaluating ERLEADA® (apalutamide) plus androgen deprivation therapy (ADT) in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The decision resulted from an Independent Data Monitoring Committee (IDMC) recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). Based on these results, the IDMC recommended that patients in the placebo plus ADT group be given the opportunity to cross over to treatment with ERLEADA plus ADT. Patients will continue to be followed for OS and long-term safety as part of the TITAN study.

"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," said Margaret Yu, M.D., Vice President, Oncology Clinical Development, Janssen Research & Development, LLC. "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."

Results from the TITAN study will be submitted for presentation at an upcoming medical congress. Applications seeking regulatory approval of ERLEADA supported by data from the Phase 3 TITAN study are planned for 2019. 

About Metastatic Castration-Sensitive Prostate Cancer
Metastatic prostate cancer is cancer that has spread to another part of the body.1 Metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT.1 Patients with newly-diagnosed metastatic disease tend to have a poorer prognosis, resulting in a need for new treatment options.2,3

About the TITAN Study
TITAN is a Phase 3 randomized, placebo-controlled, double-blind study in men who were newly diagnosed with metastatic disease, regardless of prognostic risk, volume of disease, prior treatment with docetaxel or treatment of localized disease. More than 1,050 patients with mCSPC were randomized to receive either ERLEADA plus ADT, or placebo plus ADT. Participants were treated until disease progression or the occurrence of unacceptable treatment related toxicity, or end of treatment. The dual primary endpoints of the study are rPFS and OS.4 Secondary endpoints of the study include time to chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal related event.4 For additional study information, visit ClinicalTrials.gov.

About ERLEADA
ERLEADA® (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It became the first treatment to receive FDA approval for this disease state on February 14, 2018.5 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic (M0) CRPC with a category 1 recommendation (especially for those with a PSA doubling time ≤10 months)*.6 Additionally, the American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) were updated to include apalutamide (ERLEADA) with continued ADT as a treatment option that clinicians should offer to patients with asymptomatic nmCRPC. It is included as one of the options clinicians should offer to patients with nmCRPC who are at high-risk for developing metastatic disease (Standard; Evidence Level Grade A)**.7

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 12, 2018. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

**Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.

**Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. 

1 American Society of Clinical Oncology. Prostate Cancer: Treatment Options. http://www.cancer.net/cancer-types/prostate-cancer/treatment-options. Accessed January 2019.
2 Cancer.org. Survival rates for prostate cancer. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed January 2019.
3 Fizazi K., et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. New England Journal of Medicine. June 2017. 
4 ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Available at: https://clinicaltrials.gov/ct2/show/NCT02489318
5 ERLEADA Prescribing Information, February 2018.
6 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 12, 2018. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
7 American Urological Association. Castration-Resistant Prostate Cancer Guidelines. http://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2018). Accessed January 2019.

SOURCE: Janssen

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