New Analyses from Phase III ALSYMPCA Trial Presented at ESMO 2012
Algeta ASA has announced that further data and analysis from the phase III ALSYMPCA study of radium-223 dichloride (Alpharadin) in patients with castration-resistant prostate cancer with bone metastases have been presented as two posters at the ESMO 2012 Congress (Vienna, Austria; 28 September - 2 October 2012).
Dr. Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said: “These new analyses continue to build our confidence in radium-223 dichloride’s potential for use in the treatment of castration-resistant prostate cancer patients with bone metastases.”
Both posters can be found at www.algeta.com.
Safety of chemotherapy after radium-223 dichloride (Poster 936P)
The first analysis, conducted post-hoc and presented by Dr. Oliver Sartor (Medical Director Tulane Cancer Center, Tulane Medical School, New Orleans, LA, and Principal Investigator for US arm of ALSYMPCA), found that, based on the limited sample size (n=147), hematologic safety profiles for patients receiving chemotherapy after radium-223 dichloride were similar to those for patients receiving chemotherapy after placebo.
The cohort for this analysis consisted of all patients who received chemotherapy after administration of radium-223 dichloride or placebo.
The proportion of patients receiving subsequent chemotherapy was 93/614 (15%) in the radium-223 dichloride group and 54/307 (18%) in the placebo group.
The most common chemotherapeutic agents administered after study drug treatment were docetaxel (n=105), mitoxantrone (n=23), and cyclophosphamide (n=19).
Administering chemotherapy after the study drug had no deleterious effect on patient overall survival (OS).
In the 147 patients from the ALSYMPCA study receiving chemotherapy after study drug, median OS from start of chemotherapy was 15.6 months in the radium-223 dichloride group and 14.6 months in the placebo group (P = 0.663).
Quality of Life assessment (Poster 898PD)
The second, preplanned, analysis, from all 921 patients recruited into ALSYMPCA and presented by Dr. Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK, and Principal Investigator for ALSYMPCA), concluded that radium-223 dichloride showed significantly better preservation of quality of life (QOL), with improved functioning and well-being, compared to placebo, as well as confirming previously reported survival and safety endpoints.
Radium-223 dichloride improved the QOL response rate versus placebo (27% vs 18% p < 0.05), and better preserved QOL over time versus placebo (FACT-P: p < 0.05).
QOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EuroQoL (EQ-5D) instruments, both well validated instruments in prostate cancer.
Radium-223 dichloride is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.