Efficacy
Xofigo + BSC significantly extended median OS vs placebo + BSC
In the phase 3 ALSYMPCA trial, an updated analysis showed that
Median OS:
Adapted from Parker C et al. 2013.
ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with 2 or more bone metastases. Patients were randomised 2:1 to receive 6 injections (once every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival.
Xofigo + BSC significantly delays time to first symptomatic skeletal event (SSE) vs placebo + BSC
In the phase 3 ALSYMPCA trial, an updated analysis of secondary endpoints showed that
Median time to first SSE:
Adapted from Parker C et al. 2013.
ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (once every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. SSEs were defined as EBRT for pain relief, spinal cord compression, tumour-related orthopaedic surgical interventions, bone fractures. The primary endpoint was overall survival.
Improved survival with Xofigo + BSC is accompanied by a slower decline in quality of life vs placebo + BSC
A post hoc analysis of the phase 3 ALSYMPCA trial showed that
In addition,
Patients with a meaningful improvement in FACT-P total score and EQ-5D utility score:
Adapted from Nilsson S et al. 2016.
ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (once every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival. A post hoc analysis looked at health-related quality of life using two validated instruments: the general EQ-5D and the disease-specific FACT-P. Meaningful improvement defined as increase in FACT-P total score of ≥10 from baseline or an increase in EQ-5D utility score of ≥0.1 from baseline, at Week 16 and/or Week 24.
Abbreviations
BSC, best standard care; BSOC, best standard of care; EBRT, external beam radiation therapy; mCRPC, metastatic castration-resistant prostate cancer; OS, overall survival; EQ-5D, EuroQoL 5D; FACT-P, Functional Assessment of Cancer Therapy-Prostate.
PP-XOF-IE-0129-1 | February 2026
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professional are asked to report any suspected adverse reactions.