Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Janssen Announces Treatment with ERLEADA^® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Final analysis from Phase 3 TITAN study demonstrated apalutamide provided statistically significant overall survival benefit and consistent safety profile in patients with metastatic hormone-sensitive prostate cancer

BEERSE, BELGIUM February 9, 2021 – Janssen Pharmaceutica NV (Janssen) announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of apalutamide plus androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) 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 9:30 PM-10:15 PM CET).

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that apalutamide plus ADT provided statistically significant improvement in OS with a 35 percent reduction in risk of death compared to ADT alone (HR 0.65; p<0.0001).1 This result was almost similar to the OS results in the primary analysis of TITAN despite the subsequent crossover rate of almost 40 percent of the placebo-controlled group to the apalutamide arm.1 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

“Janssen is committed to uncovering new solutions for patients with prostate cancer as until very recently, there has been little advancement in treatment options for people with metastatic hormone-sensitive prostate cancer,”² said Dr Catherine Taylor, Vice-president, Medical Affairs, Therapeutic Area Strategy for Europe, Middle East and Africa, Johnson & Johnson Middle East FZ-LLC. “The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer.”

There was consistent benefit across other endpoints, including improved second progression-free survival (PFS2) (HR 0.62; p<0.0001) and delayed time to castration resistance (HR 0.34; p<0.0001).1 In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained in both groups. Safety of apalutamide was consistent with previously reported studies.1 Observed adverse events included skin rash, fracture, and falls.¹

“The TITAN final analysis is a welcome development for the management of metastatic hormone-sensitive-prostate cancer2 as the data show us that apalutamide with ADT improves long-term clinical benefit and prolonged overall survival, without compromising health-related quality of life for these patients,” said Professor Axel Merseburger, Chairman of the Clinic of Urology, Universitatsklinikum Schleswig-Holstein and investigator of the TITAN study. “The results also demonstrate an established safety profile which is encouraging for the management of patients living with advanced forms of prostate cancer.”

Initial results from the TITAN study presented at the 2019 American Society of Clinical Oncology Annual Meeting (ASCO) and simultaneously published in The New England Journal of Medicine showed the addition of 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 mHSPC.³

To date, published results on apalutamide include data from more than 2,000 patients across Phase 3 clinical studies.3 Apalutamide has shown a statistically significant improvement in OS with a consistent safety profile in both approved indications of mHSPC (TITAN) and non-metastatic castration-resistant prostate cancer or nmCRPC  (SPARTAN).3

*Professor Axel Merseburger is an investigator of the TITAN study and has been compensated for media work.