“As people age, the risk of fracturing a bone – whether it’s a hip, a wrist, vertebrae, an ankle or toe, climbs steadily. For women and men who live after a cancer diagnosis, the risk of breaking bone is greater.
“At this year’s San Antonio Breast Cancer Symposium, Dr. Michael Gnant of Vienna gave an update on a major trial of denosumab in its capacity to reduce fractures and possibly stave off metastases. This drug is manufactured and sold by Amgen in a low-dose form as Prolia. Prolia is a monoclonal antibody that doesn’t require intravenous administration; it’s injected under the skin, just twice each year.
“The ongoing trial, by the Austrian Breast and Colorectal Cancer Study Group (ABCSG), includes over 3,400 postmenopausal women with non-metastatic, hormone receptor positive breast cancer. All participants took an aromatase inhibitor, a standard treatment given to lower hormone levels, and were randomized to receive either low-dose (60 milligrams) denosumab or a placebo injection under the skin, twice yearly.”
“Amgen AMGN 0.49% today announced results from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the treatment effect of adjuvant Prolia® (denosumab), 60 mg once every six months, therapy in postmenopausal women with early hormone receptor positive (HR+) breast cancer receiving aromatase inhibitor therapy. The trial met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p<0.0001). The observed 50 percent reduction in fractures between the Prolia and placebo arms, 92 versus 176, respectively, was similar in patients with normal bone health at baseline (n=1,872, HR=0.44, p<0.0001) and in patients who started the trial with early signs of bone loss (n=1,548, HR=0.57, p=0.0021). The data will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago today at 9:12 a.m. CT (abstract no. 504). In addition to the presentation, the paper was published online by The Lancet.
“This is the first Prolia trial to enroll patients independent of baseline bone mineral density (BMD) and with the majority in the normal BMD range. The study, which enrolled a total of 3,425 patients, was conducted by the Austrian Breast and Colorectal Cancer Study Group (ABCSG).
” ‘Fracture is a common side effect of aromatase inhibitors, which are an important first-line therapy for postmenopausal women with non-metastatic breast cancer,’ said principal investigator Michael Gnant, professor of surgery at Medical University of Vienna. ‘These encouraging data demonstrate the potential benefit of initiating Prolia simultaneously with aromatase inhibitor therapy, regardless of the patient’s baseline BMD, to decrease the risk of fracture.’ “
Advanced prostate cancer patients used to be treated with palliative chemotherapy that did not improve survival. But in the past decade, researchers have introduced several new therapies for castration-resistant prostate cancer (CRPC) and related complications. These drugs include cabazitaxel (Jevtana), abiraterone acetate (Zytiga), enzalutamide (Xtandi), sipuleucel-T (Provenge), radium-223, and denosumab (Xgeva or Prolia). Two researchers recently performed a cost-benefit analysis on these new therapies. They say that costs will come down as treatment strategies—including precisely timed combinations of drugs—are refined to minimize progression and side effects.