Date: 2011-12-09
Type of information:
phase: 2a
Announcement: results
Company: Algeta (Norway)
Product: Alpharadin® (radium-223 chloride)
Action mechanism: Alpharadin® (radium-223 chloride) is containing an alpha-particle emitting nuclide. This compound mimics many of the behaviors of calcium in the bone to target areas of high bone turnover in and around bone metastases.
Disease: endocrine-refractory breast cancer patients with bone metastases
Therapeutic area: Cancer - Oncology
Country: Belgium, Norway, UK
Trial
details: BC1-09 is an open-label, single arm phase IIa trial evaluating the potential of Alpharadin® to treat bone metastases in patients with breast cancer that has spread primarily to the bone and that no longer responds to endocrine therapy. The study was conducted at four cancer centers - in Norway (Oslo), Belgium (Brussels and Liege) and the UK (Sheffield). The study included metastatic breast cancer patients with bone-dominant disease who had progressed (based on imaging or other clinically relevant information) on endocrine therapy and were no longer considered suitable for endocrine therapy. In this open-label, multicenter, single-arm, phase IIa study, 23 patients were scheduled to receive four intravenous injections of radium-223 chloride 50 kBq/kg every four weeks. Bone markers were assessed at baseline, prior to every treatment, and thereafter at each follow-up visit. The co-primary efficacy endpoints were changes from baseline in urine levels of N-telopeptide (uNTX) and bone alkaline phosphatase (bALP) at 16 weeks. Functional imaging with FDG-PET was performed in 20 patients at baseline and weeks 8
Latest
news: * On December 9, 2011, Algeta has announced that positive results from the phase IIa BC1-09 clinical study evaluating Alpharadin® (radium-223 chloride) in endocrine-refractory breast cancer patients with bone metastases were presented in a poster at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium (San Antonio, TX, USA). These results confirm the positive preliminary results announced by Algeta and Bayer Pharma AG in June 2011. Analysis of the trial data found that Alpharadin® treatment met the co-primary endpoints by significantly reducing the levels of bone alkaline phosphatase (bALP), and urine N-telopeptide (uNTX) during the 16-week treatment period in breast cancer patients with bone metastases receiving bisphosphonates. These parameters are used as key markers of bone involvement in breast cancer.
Median uNTX levels were reduced by 20% (from 36 to 29 nmolBCE/mmol creatinine; p=0.0164) and by 33% (from 36 to 24 nmolBCE/mmol creatinine; p=0.0201), at weeks 8 and 16, respectively; 17/23 and 13/16 patients had a decrease in uNTX at weeks 8 and 16, respectively.
Median bALP levels were reduced by 45% (from 22.1 to 12.1 ng/mL; p=0.001) at week 8 and by 51% (from 22.1 to 10.9 ng/mL; p=0.0045) at week 16; bALP levels were reduced in 20/22 patients at week 8 and in 14/16 patients at week 16.
Alpharadin® was also found to be safe and well-tolerated in the study, confirming the well-tolerated side effect profile seen in other studies. Three patients reported serious adverse events, although none of these events was deemed to be related to the study drug.
The poster (number P4-16-04, abstract 41.035, Coleman, et al.) was entitled \"An open-label, phase IIa, non-randomized study of radium-223 in breast cancer patients with bone dominant disease no longer considered suitable for endocrine therapy.
* On June 7, 2011, Algeta announced that preliminary data from its phase IIa study of Alpharadin® (radium-223 chloride) for the treatment of bone metastases in 23 patients with endocrine-refractory breast cancer showed positive results for bone markers. Preliminary top-line results showed that Alpharadin® reduced the levels of bone alkaline phosphatase (bALP), and urine N telopeptide (uNTX). These parameters are used as key markers of bone involvement in breast cancer.
