Abiraterone Acetate Plus Prednisone Provided Significant Clinical Benefits in Patients With High-Risk Metastatic Hormone Prostate Cancer

Janssen-Cilag International NV today announced data from the pivotal Phase 3 LATITUDE clinical trial, which showed that Zytiga® plus Prednisone plus combination of androgen deprivation therapy (ADT) compared to ADT plus placebo, survival and radiological progression-free survival in patients with newly diagnosed and high-risk metastatic prostate cancer (mHNPC) (patients who had not previously been treated with ADT). These data were selected as one of four sets of data for inclusion in the Press Program of the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, today between 8 and 9 in the morning. In addition, the results of the data will be presented during the “Plenary Session: Including the Oncology Science Award and Conference”, on Sunday, June 4, at 2:40 – 2:55 pm CDT (Abstract LBA3) . The data have been selected for the “Best of ASCO” meetings that highlight the most cutting edge science and education at the ASCO Annual Meeting and reflect the research and the most important oncology strategies that will directly impact patient care.

The results of the study indicated that treatment with abiraterone acetate plus prednisone in combination with ADT reduced the risk of death by 38% compared with ADT and placebo (hazard ratio [HR] = 0.62, 95% CI, [0.51 to 0.76], p <0.0001). Additional results from the study found that treatment with abiraterone acetate plus prednisone in combination with ADT reduced the risk of disease progression in scans or death by 53% compared to ADT plus placebo in patients with mHNPC (HR = 0 , 47, 95% CI 0.55], P <0.0001). The median rPFS was 33.0 months with ADT in combination with abiraterone acetate plus Prednisone, compared to 14.8 months with ADT and placebo.

“In the LATITUDE study, we found that abiraterone acetate plus prednisone in combination with androgen deprivation therapy demonstrated statistically significant and clinically significant improvements in patients with metastatic prostate cancer at high risk,” said Dr. Karim Fizazi , Principal Investigator of the trial and Head of the Department of Medical Oncology of the Gustave Roussy Institute. “This is important new information as not all patients respond well to the current standard of care. LATITUDE suggests that abiraterone acetate plus Prednisone, in combination with androgen deprivation therapy, may offer a new and much needed option For patients at high risk for newly diagnosed mHNPC. ”

There are approximately 420,000 men diagnosed with prostate cancer in Europe per year.2 About 2% -43% (up to 180,000) have metastatic prostate cancer. Historically, ADT and docetaxel have been the standard of care for patients With metastatic prostate cancer. This is often very effective in reducing or decreasing the growth of prostate cancer that has spread, but is usually less effective over time.

In addition to achieving a significant improvement in both the primary endpoints of OS and rPFS, the LATITUDE study met all secondary endpoints, with statistically significant improvements in abiraterone acetate plus prednisone arm over time: progression Pain, initiation of chemotherapy, prostate-specific antigen (PSA) progression (all p <0.0001) and the following skeletal related event (p = 0.0086).

In general, the safety profile of ADT in combination with abiraterone acetate plus Prednisone was consistent with previous studies in patients with castration-resistant metastatic prostate cancer (mCRPC). The most common and anticipated adverse events were high incidences of mineralocorticoid-related hypertension and hypokalemia in ADT in combination with abiraterone acetate plus Prednisone arm compared to ADT and placebo.

“Prostate cancer is the most common cancer in men in Europe, affecting more than three million patients in the region. When the disease metastasizes and spreads to other parts of the body, it can become very aggressive and difficult To treat, “said Dr. Ivo Winiger-Candolfi, Head of Solid Oncology Tumor Therapy Area, Janssen Europe, Middle East, Africa. “Janssen has played a major role in addressing the challenges of treatment and transformation of the metastatic form of prostate cancer managed in the past seven years. We are very excited to see the positive results from LATITUDE data for abiraterone acetate plus Prednisone in metastatic prostate cancer without hormonal complications.This data has served as the basis for our presentation to the European Medicines Agency (EMA) to extend the use of abiraterone acetate plus Prednisone to include an earlier stage of prostate cancer than its Current indications and remain committed to helping these patients benefit from treatment in the future. “