“The Food and Drug Administration granted Xtandi (enzalutamide) a priority review to a supplemental new drug application for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to the companies developing the drug, Pfizer and Astellas.
“The sNDA is based on data from the phase 3 PROSPER trial in which the combination of Xtandi and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71 percent compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone.”
“Fifteen years ago, Michael Jung was already an eminent scientist when his wife asked him a question that would change his career, and extend the lives of many men with a particularly lethal form of prostate cancer.
” ‘When I turned 55—I’m now 70—my wife, Alice, said to me, “What do you want to do for the rest of your life, more of the same?” ‘ recalled Jung, a UCLA distinguished professor of chemistry and biochemistry. ‘I said that didn’t sound like such a bad idea until you put it that way.’ ”
“In two separate trials presented at the 2018 Genitourinary Cancers Symposium, apalutamide and enzalutamide (Xtandi), respectively, reduced the risk of metastasis and prolonged metastasis-free survival in men with high-risk nonmetastatic castrate-resistant prostate cancer. In the SPARTAN trial, apalutamide reduced the risk of developing metastasis and death by 72% compared with placebo, and in the PROSPER trial,enzalutamide reduced the risk of metastasis or death by 71% compared with placebo. In both studies, men were treated with ongoing androgen-deprivation therapy.”
“Use of Xtandi in early stage prostate cancer on top of standard hormone therapy reduced the risk of disease spreading or death by 71 percent compared with hormone therapy alone, study results that could lead to significantly increased sales of the Pfizer Inc and Astellas Pharma Inc medicine.
“The data from a highly anticipated study released on Monday showed that it took 36.6 months for the disease to spread to other parts of the body in patients who received Xtandi plus androgen deprivation therapy (ADT), a measure known as median metastasis-free survival. That compared with 14.7 months for ADT alone, a highly statistically significant difference of nearly two years.”
“Enzalutamide (Xtandi) demonstrated early signs of efficacy in patients with androgen receptor (AR)-positive triple-negative breast cancer (TNBC), according to findings from the phase II MDV3100-11 study published in the Journal of Clinical Oncology.
“A total of 118 patients were enrolled in the single-arm, 2-stage trial, and 78 were evaluable for response. At 16 weeks, the clinical benefit rate (CBR) was 25% (95% CI, 17-33) in the intent-to-treat (ITT) population and 33% (95% CI, 23-45) in the evaluable subgroup. The median progression-free survival (PFS) was 2.9 months (95% CI, 1.9-3.7) in the ITT population and 3.3 months (95% CI, 1.9-4.1) in the evaluable subgroup. Median overall survival (OS) was 12.7 months (95% CI, 8.5 – not yet reached) in the ITT population and 17.6 months (95% CI, 11.6 – not yet reached) in the evaluable subgroup.”
“In patients with hormone receptor (HR)-positive advanced breast cancer and no prior endocrine therapy who were positive for a gene signature-based biomarker indicating androgen receptor (AR)-signaling, the addition of enzalutamide (Xtandi) to exemestane was found to significantly improve progression-free survival (PFS) from 4 months to 16.5 months.
“Moreover, the phase II trial showed no effect of enzalutamide on PFS in the overall cohort of patients nor in the biomarker-positive population who received prior endocrine therapy, said Denise Yardley, MD, at the 2017 San Antonio Breast Cancer Symposium.”
“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).”
“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.”
“Patients with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases (liver and lung) fare better with the androgen receptor inhibitor enzalutamide than placebo, according to a new analysis from the phase III AFFIRM trial. There were differences in response based on which of those two sites had metastases, suggesting they should be considered differently for treatment.
” ‘Visceral metastases are identified in approximately 22% to 30% of patients with mCRPC and are associated with unfavorable outcomes,’ wrote study authors led by Yohann Loriot, MD, PhD, of Université Paris-Saclay in Villejuif, France.”