“The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, ZYTIGA® in combination with prednisone reduced the risk of death by 38 percent compared to placebos.”
“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.
“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”
“The first head-to-head comparison of docetaxel and abiraterone acetate for high-risk prostate cancer patients starting long-term hormone therapy found benefit with both treatments when added to androgen deprivation therapy (ADT). Treatment decisions may come down to specific toxicities, which differ between the treatments.
“The large STAMPEDE trial previously found that both docetaxel and abiraterone improved outcomes when compared with placebo. “Right now, oncologists and urologists want to know which combination is preferable, which is why we conducted this analysis,” said study author Matthew Sydes, MSc, a statistician at University College London.”
“Patients with high risk prostate cancer starting long-term hormone therapy may benefit from two new treatments, according to late-breaking results from the STAMPEDE trial presented at the ESMO 2017 Congress in Madrid.
“Long-term hormone therapy alone has been the standard of care for patients with high risk locally advanced or metastatic prostate cancer since the 1940s.”
“A late-stage trial found that continuing treatment with Pfizer Inc’s cancer drug Xtandi in addition to a regimen of Zytiga and a steroid worked no better than the two other drugs alone in patients with advanced prostate cancer whose disease had worsened, the company said on Wednesday.
“Zytiga, or abiraterone acetate, is sold by Johnson & Johnson.”
“Neoadjuvant enzalutamide (ENZA) and abiraterone acetate (AA) plus 5 mg prednisone daily can be given safely for 6 months in men with localized high-risk prostate cancer prior to prostatectomy, a neoadjuvant study showed.
“However, the findings did not favor adding ENZA to augment AA plus leuprolide acetate (LHRHa) efficacy in localized high-risk prostate cancer, Eleni Efstathiou, MD, PhD, of the University of Texas MD Anderson Cancer Center, in Houston, said during a presentation at the American Society of Clinical Oncology.
“Pathologic downstaging (≤ pT2N0) occurred in 30% of patients treated with the combination therapy (AA+ENZA+ LHRHa) versus 52% of patients who received AA plus LHRHa alone (P=0.07), the study showed. Despite universal PSA depletion (≤ 0.1), a wide range of viable tumor was observed (volume 0-8.64 cc, cellularity 0-90%, and a tumor epithelial volume [TEV] 0-5.58 cc). TEV and stage were aligned.”
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“Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared with placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.
“Data presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated that in the COU-AA-302 trial, Zytiga (abiraterone acetate) increased OS to 53.6 months versus the 41.8 months achieved by patients treated with prednisone alone. This benefit was shown to be 4.4 greater than that previously reported for the combo in the final analysis of the COU-AA-302 trial in 2014.
“The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in group 1 were in an earlier, less advanced and less symptomatic stage of the disease, while those in group 2 were in a later, more advanced and more symptomatic stage of the disease.”
“Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).
“The designation, which will accelerate the development and review of the first-in-class oral PARP inhibitor, is based on data from the phase II TOPARP-A trial that demonstrated that olaparib monotherapy had an overall response rate (ORR) of nearly 90% in a biomarker-defined subgroup of patients who had DNA-repair defects.“
University of Colorado Cancer Center | Dec 3, 2015
“In 1048 prostate cancer patients previously treated with docetaxel and 996 metastatic, castration-resistant patients, treatment with the androgen-lowering drug abiraterone acetate (Zytiga) led to longer overall disease control, even when a very high Gleason score indicated especially aggressive cancer.Results recently published in the Annals of Oncology show that for patients with Gleason score greater than 8, post-docetaxel treatment with abiraterone extended progression-free survival from 5.5 months to 6.4 months, and pre-chemotherapy abiraterone treatment extended progression-free survival from 8.2 months to 16.5 months.”