Newswire (Published: Friday, June 14, 2019, Received: Friday, June 14, 2019, 3:43:40 PM CDT)

Word Count: 783

2019 JUN 14 (NewsRx) -- By a News Reporter-Staff News Editor at NewsRx Drug Daily -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the investigational Phase 3 TITAN study, which showed the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) compared with placebo plus ADT significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic castration-sensitive prostate cancer (mCSPC).1 The study included patients with mCSPC regardless of extent of disease or prior docetaxel treatment history.1 Results were presented in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago ( abstract #5006), and simultaneously published online in The New England Journal of Medicine.The data were selected for the Best of ASCO 2019 Meetings, which highlight cutting-edge science and reflect leading research in oncology.

ERLEADA plus ADT significantly extended OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95 percent CI, 0.51-0.89; P=0.0053).1 ERLEADA plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95 percent CI, 0.39-0.60; P<0.0001).1 The two-year OS rates, after a median follow-up of 22.7 months, were 82 percent for ERLEADA plus ADT compared to 74 percent for placebo plus ADT.1

These data formed the basis of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA for the treatment of patients with mCSPC, which is currently under review through the Real-Time Oncology Review (RTOR) program.

“Patients with metastatic castration-sensitive prostate cancer typically have a poor prognosis, with a median overall survival of less than five years. Despite advances in treatment, there is still a critical need to improve outcomes for these patients,” said Dr. Kim Chi, Medical Oncologist at BC Cancer - Vancouver and principal investigator of the study. “These data suggest that apalutamide prolongs overall survival and delays disease progression in patients with metastatic castration-sensitive prostate cancer.”

In addition to meeting the primary dual endpoints of OS and rPFS, the secondary endpoint of prolonged time to cytotoxic chemotherapy in patients treated with ERLEADA plus ADT was also met, with a 61 percent risk reduction compared with placebo plus ADT (HR=0.39; 95 percent CI, 0.27-0.56; P<0.0001).1 In exploratory endpoints, median time to PSA progression was more favorable following ERLEADA plus ADT, compared with placebo plus ADT, and prostate-specific antigen (PSA) reached undetectable levels in 68 percent of patients in the ERLEADA plus ADT arm and 29 percent of patients in the placebo plus ADT arm.1 Additionally, ERLEADA plus ADT, compared with placebo plus ADT, achieved a 34 percent risk reduction in median time to second progression-free survival (PFS2), defined as time from randomization to either disease progression on first subsequent anticancer therapy or death, whichever occurred first (HR=0.66; 95 percent CI, 0.50-0.87).1 Although time to pain progression was tested, it did not reach statistical significance. Due to a hierarchical statistical design, no formal testing for further secondary endpoints, including median time to chronic opioid use and median time to skeletal-related events, were conducted at this time.1

Adverse events were generally consistent with the known ERLEADA safety profile. The most common Grade 3/4 adverse events (AEs) for ERLEADA plus ADT, versus placebo plus ADT were similar (42 percent vs. 41 percent).1 The most common Grade 3 AEs for ERLEADA plus ADT versus placebo plus ADT were hypertension (8.4 percent vs. 9.1 percent) and skin rash (6.3 percent vs. 0.6 percent).1 Additional reported Grade 3 AEs for ERLEADA plus ADT versus placebo plus ADT were back pain (2.3 percent vs. 2.7 percent), blood alkaline phosphatase increased (0.4 percent vs. 2.5 percent) and anemia (1.7 percent vs. 3.2 percent).1 Treatment discontinuation due to AEs was 8 percent in the ERLEADA arm compared to 5 percent in the placebo arm.1 Rash of any grade was more common among patients treated with ERLEADA plus ADT, versus placebo plus ADT (27 percent vs. 9 percent, respectively).1

“The TITAN study results demonstrate that the addition of ERLEADA to ADT improves clinical outcomes without compromising health-related quality of life for a broad range of patients with metastatic castration-sensitive prostate cancer,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “These data suggest that ADT alone should no longer be considered the standard of care for metastatic castration-sensitive prostate cancer and support Janssen’s investigation of ERLEADA in earlier stages of prostate cancer.”

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