Janssen Biotech seeks U.S. approval to use a triple combination treatment with Zytiga (abiraterone acetate), prednisone and androgen deprivation therapy (ADT) for men with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).
As such, the Danish pharmaceutical giant submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for that purpose.
Metastatic hormone-naïve prostate cancer (mHNPC) is prostate cancer that has spread to other locations in the body but has not been previously treated with ADT, and is not castration- resistant. Metastatic hormone-sensitive prostate cancer (mHSPC) is prostate cancer that still responds to testosterone suppression therapy.
The application follows promising results from the LATITUDE Phase 3 trial (NCT01715285), testing the triple combo for newly diagnosed, high-risk metastatic prostate cancer.
Researchers outlined the trial’s results during the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The study also appeared in the New England Journal of Medicine. Additional data from the study were presented at the recent European Society for Medical Oncology (ESMO) 2017 Annual Conference in Madrid.
Zytiga inhibits androgen production, while prednisone is an immunosuppressant. It is already approved, in combination with prednisone, to treat metastatic castration-resistant prostate cancer.
The LATITUDE trial, conducted at 235 sites in Canada and 33 countries in Europe, Asia and Latin America, randomized 1,199 men to receive ADT plus Zytiga and prednisone or ADT plus placebo.
The study found that when Zytiga and prednisone were added to ADT treatment, patients’ risk of death fell by 38 percent and their risk of disease progression dropped by 53 percent. Disease progression was delayed by a median of 33 months in men on the triple combo, compared to a median 14.8 months for those on placebo.
The triple combo also decreased pain intensity and fatigue, and slowed health-related quality of life degradation, compared to ADT alone.
“We are excited about the promising results from the LATITUDE study which 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,” Dr. Craig Tendler, vice president of late-stage development and global medical affairs at Janssen’s oncology, hematology and supportive care division, said in a press release. “We look forward to working with the FDA on the review of this application to provide a new therapeutic option for men with newly diagnosed, high-risk metastatic prostate cancer.”