On September 17, 2019, the FDA approved apalutamide (Erleada®, Janssen Biotech, Inc.) in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (CSPC). The approval was based on TITAN (NCT02489318), a Phase III clinical trial led by Kim N. Chi, MD, Vice President of BC Cancer Agency in Vancouver and Professor of Medicine at the University of British Columbia. In this interview with i3 Health, Dr. Chi discusses the significance of the approval and the future of treatment for metastatic CSPC.
Can you comment on the significance of the approval of apalutamide for patients with metastatic CSPC?
Kim N. Chi, MD: This is an important new treatment option for men with metastatic CSPC, which is a lethal stage of prostate cancer. In a broad range of men with metastatic CSPC, apalutamide in combination with ADT significantly improved overall survival and radiographic progression-free survival, with an excellent tolerability profile and maintenance of quality of life.
How does apalutamide in combination with ADT compare with other current treatments for metastatic CSPC, in terms of both efficacy and adverse events?
Dr. Chi: Another treatment option for metastatic CSPC is docetaxel chemotherapy with ADT, as well as abiraterone acetate plus prednisone with ADT. Cross-trial comparison suggests a similar level of improved efficacy associated with these treatments compared with ADT alone. However, apalutamide has a favorable side effect profile, particularly compared with chemotherapy, as well as compared with abiraterone plus prednisone.
How do you see the treatment of metastatic CSPC evolving?
Dr. Chi: In the coming years, ongoing clinical trials will allow us to better understand how triplet therapy—docetaxel plus ADT plus androgen receptor (AR)-targeted therapy—compares with doublet therapy (docetaxel plus ADT). The other evolving area will be the development of better biomarkers to understand which patients need intensified therapy versus which patients do not.
Do you have any words of advice for community oncologists and urologists treating patients with metastatic CSPC?
Dr. Chi: The weight of clinical evidence supports the fact that ADT alone is not sufficient for the treatment of metastatic CSPC. Therefore, the standard of care should be to always consider intensified therapy with the addition of docetaxel, abiraterone, or now a new option, apalutamide.
About Dr. Chi
Kim N. Chi, MD, is a Professor of Medicine at the University of British Columbia, the Chief Medical Officer and Vice President at BC Cancer Agency, and a Senior Research Scientist and Associate Director of Clinical Research at Vancouver Prostate Centre. He also serves as Co-Chair of the Genitourinary Disease Site for the Canadian Cancer Trials Group and the Canadian Uro-Oncology Group. Dr. Chi specializes in the treatment of genitourinary cancers and has led national and international clinical trials focusing on the development of new drugs for the treatment of prostate cancer.
For More Information
Chi KN, Agarwal N, Bjartell A, et al (2019). Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. [Epub ahead of print] DOI:10.1056/NEJMoa19033307
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily represent those of i3 Health.