18 Oct ZYTIGA May Benefit Newly Diagnosed High-Risk Metastatic Prostate Cancer
MedicalResearch.com Interview with:
Craig Tendler, M.D.
Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care
Janssen Research & Development, LLC.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Janssen announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of ZYTIGA in combination with prednisone and androgen deprivation therapy (ADT) to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).
This submission is based on the pivotal Phase 3 LATITUDE trial results presented earlier this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting, which found that in patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHNPC), abiraterone acetate with prednisone in combination with androgen deprivation therapy (ADT) demonstrated a significant improvement in median overall survival (OS) and in radiographic progression-free survival (rPFS). Additional data, which were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference, demonstrated clinically meaningful and statistically significant improvements in patient reported outcomes (PRO) in patients with high-risk mHNPC who received ZYTIGA in combination with prednisone and ADT compared to placebo plus ADT alone.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The promising results from the LATITUDE study suggest that ZYTIGA can benefit men with newly diagnosed, high-risk metastatic prostate cancer, rather than waiting for them to become resistant to conventional hormonal treatments.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In addition to this potential new indication for ZYTIGA, Janssen is investigating apalutamide and niraparib, two promising late-stage compounds which hopefully can build on Zytiga’s success and improve outcomes for patients with either localized or advanced prostate cancer.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Expand the indication of ZYTIGA® in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.