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Xofigo®(radium-223 dichloride)

Efficacy

Xofigo + BSC significantly extended median OS vs placebo + BSC

In the phase 3 ALSYMPCA trial, an updated analysis showed that Xofigo + BSC significantly extended median OS by 3.6 months vs placebo + BSC (14.9 months vs 11.3 months, respectively; P<0.001).

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 Xofigo + BSC significantly delayed time to first SSE by 5.8 months vs placebo + BSC (15.6 months vs 9.8 months, respectively; P<0.001).

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 significantly more patients treated with Xofigo + BSC experienced a meaningful improvement in quality of life (as measured by FACT-P total score or EQ-5D utility score) vs placebo + BSC (P=0.02 and P=0.004, respectively).

In addition, significantly more patients experienced pain relief with Xofigo + BSC than placebo + BSC (30.2% [129/427] vs 20.1% [37/184], respectively; P=0.01)

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.}

References

1
Xofigo®(radium-223 dichloride): Summary of Product Characteristics.
2
Parker C, et al. Prostate Cancer Prostatic Dis. 2018;21(1):37-47.
3
Parker C, et al. N Engl J Med. 2013;369(3):213-223.
4
Nilsson S, et al. Ann Oncol. 2016;27(5):868-874.