DCSIMG

Efficacy in Preventing Time to First Skeletal-Related Event (SRE) in a Subgroup Analysis of Other Solid Tumors in Patients with Bone Metastases vs Zoledronic Acid

XGEVA®: Risk reduction in a head-to-head study vs
zoledronic acid in other solid tumors*/multiple myeloma1,2

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XGEVA®: Risk reduction in a head-to-head study vs zoledronic acid in other solid tumors*/multiple myeloma

Data from a phase 3, randomized, double-blind, double-dummy, active-controlled study comparing XGEVA® with zoledronic acid for the prevention of skeletal-related events (SREs) in patients with bone metastases from other solid tumors (other than breast or prostate) or multiple myeloma (N = 1,776). Zoledronic acid 4 mg was administered as an IV infusion over a minimum of 15 minutes, once every 4 weeks, in accordance with prescribing information. XGEVA® was administered subcutaneously 120 mg, once every 4 weeks. The primary endpoint was time to first SRE (noninferiority), and the secondary endpoints were time to first SRE (superiority) and time to first and subsequent SREs (superiority). SREs are defined as radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression.1,2

A total of 40% of patients had non-small cell metastatic lung cancer, 10% had multiple myeloma, 9% had metastatic renal cell carcinoma, and 6% had small cell metastatic lung cancer. Other tumor types each comprised less than 5% of the enrolled population. Metastatic bladder cancer, metastatic rectal cancer, metastatic colon cancer, and other metastatic cancers (eg, head and neck, cervical, gastric, non-Hodgkin's lymphoma, soft tissue sarcoma, endometrial, esophageal, neuroendocrine/carcinoid, melanoma, ovarian, thyroid, pancreatic) accounted for the remaining percentage of tumor types.1,5

*Excluding breast and prostate cancer.

Hazard ratio (HR) is defined as the increase or decrease in likelihood of an event of interest (in this case an SRE) for one group relative to that in a comparator group.

P value for superiority.


  • XGEVA® reduced the risk of first SRE by 16% vs zoledronic acid in other metastatic solid tumors and multiple myeloma (P < 0.001, noninferiority; P = 0.060, NS for superiority)
    • Pivotal phase 3 trial vs zoledronic acid (N = 1,776)
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XGEVA® (denosumab) is indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Important Safety Information

XGEVA® (denosumab) is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Osteonecrosis of the jaw and atypical femoral fracture have been reported. XGEVA® can cause fetal harm. Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®.


Efficacy in a Subgroup Analysis of Other Solid Tumors in Patients with Bone Metastases vs Zoledronic Acid

XGEVA®: Risk reduction in first and subsequent SREs
vs zoledronic acid in other solid tumors*/multiple myeloma1,2

Scroll to view risk reduction for first SREs Link Arrow
XGEVA®: Risk reduction in first and subsequent SREs vs zoledronic acid in other solid tumors/multiple myeloma

XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Important Safety Information

XGEVA® (denosumab) is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Osteonecrosis of the jaw and atypical femoral fracture have been reported. XGEVA® can cause fetal harm. Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®

*Excluding breast and prostate cancer.

Rate ratio (RR) is defined as the ratio between the incidence rates of an event across 2 groups, where each patient may have 0, 1, or any number of events. In this case, there may not be a one-to-one correspondence between the events and the patient. Each patient may have multiple events recorded.

P value for superiority.

§Cumulative mean number of SREs is the increasing average number of SREs experienced by patients over time based on multi-event analysis (1 or more SREs).

50% of patients had experienced an SRE prior to trial enrollment2

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  • Indication

XGEVA® is indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

  • Important Safety Information

XGEVA® (denosumab) is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Osteonecrosis of the jaw and atypical femoral fracture have been reported. XGEVA® can cause fetal harm. Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®.



Indication

XGEVA® (denosumab) is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Important Safety Information

Hypocalcemia Hypersensitivity Drug Products with Same Active Ingredient Osteonecrosis of the Jaw Atypical Subtrochanteric and Diaphyseal Femoral Fracture Embryo-Fetal Toxicity Adverse Reactions Please see Full Prescribing Information

References

  1. XGEVA® (denosumab) prescribing information, Amgen.

  2. Henry DH, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011;29:1125-1132.

  3. Henry DH, von Moos R, Hungria V, et al. Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of solid tumors. J Clin Oncol. 2010;28(suppl):15s. Abstract 9133 and poster.

  4. Data on file,Amgen.

  5. Data on file,Amgen.