- Johnson & Johnson’s (NYSE: JNJ) unit Janssen Pharmaceutical has announced results from Phase 3 ACIS study, evaluating the efficacy and safety of Erleada (apalutamide) and Zytiga (abiraterone) plus prednisone (treatment arm) compared to placebo and Zytiga plus prednisone (control arm) in prostate cancer patients with chemotherapy-naïve disease who received androgen deprivation therapy. JNJ will present the results at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium.
- The study met the primary endpoint of radiographic progression-free survival (rPFS) with a 31% reduction in radiographic progression or death risk. Primary efficacy analysis showed median rPFS was extended by six months in patients treated in the treatment combination arm compared with patients in the control arm (22.6 vs. 16.6 months; hazard ratio 0.69 ).
- Updated analysis at a median follow-up of 54.8 months showed a 30 percent reduction in the risk of radiographic progression or death in the treatment arm than the control arm (median time to rPFS 24 vs. 16.6 months: HR 0.70).
- No statistically significant difference was demonstrated for overall survival, time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms.
- Erleada is FDA approved treatment for non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
- Zytiga in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
- Price Action: JNJ shares closed 0.3% higher at $164.92 on Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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