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Trials Define Anti-Tumor Effects of Anti-Resorptive Agents

Denosumab Ahead of Zoledronate 2 to 1

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Abstract

New data presented at the 2010 meeting of the American Society of Hematology (ASH), at the 33rd San Antonio Breast Cancer Symposium (SABCS), and released by Amgen are beginning to define the anti-tumor effects of Amgen’s denosumab (Xgeva™) and Novartis’s zoledronate (Zometa®) in multiple myeloma, breast cancer, and prostate cancer.

Just prior to the ASH meeting, Amgen received approval of denosumab for oncology indications. The antibody against RANK ligand, already approved as Prolia® for osteoporosis, will need to demonstrate advantages over its primary competitor zoledronate, a bisphosphonate.

Multiple myeloma data presented at the ASH meeting defined zoledronate’s ability to slow progression of disease as well as promote bone health, giving zoledronate a clear advantage over denosumab in myeloma. However, zoledronate failed to show an anti-tumor effect in the AZURE trial (Adjuvant Zoledronic Acid to Reduce Recurrence) presented at the SABCS, while denosumab data presented at the meeting suggested slightly greater efficacy than zoledronate in breast cancer.

Finally, top-line results from the ′147 trial (Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer) suggest that denosumab can help prevent bone metastases in prostate cancer, an ability not yet shown by zoledronate.

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Notes

  1. NCT codes represent the ClinicalTrials.gov identifier for the indicated trial.

References

  1. Morgan GJ, Davies FE, Gregory WM, et al. Optimising bone disease in myeloma; zoledronic acid plus thalidomide combinations improves survival and bone endpoints: results of the MRC Myeloma IX Trial [abstract no. 311]. 52nd ASH Annual Meeting and Exposition; 2010 Dec 4-7; Orlando (FL) [online]. Available from URL: http://ash.confex.com/ash/2010/webprogram/Paper31442.html [Accessed 2011 Feb 17]

  2. Coleman RE, Thorpe HC, Cameron D, et al. Adjuvant treatment with zoledronic acid in stage II/III breast cancer: the AZURE trial (BIG 01/04) [abstract no. S4-5]. 33rd Annual San Antonio Breast Cancer Symposium; 2010 Dec 8-12; San Antonio (TX) [online]. Available from URL: http://www.abstracts2view.com/sabcs10/view.php?nu=SABCS10L_226 [Accessed 2011 Feb 17]

  3. Stopeck AT, Lipton A, Body JJ, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol 2010 Dec 10; 28(35): 5132–9

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  4. Weintraub B. Xgeva ahead of Zometa 2 to 1 in busy December: trials define antitumor effects of anti-resorptive agents. inThought Research, 2010 Dec 21

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Acknowledgments and Disclosures

The original in Thought™ Research Report[4] this article is adapted from is available on request from biodrugs@adis.co.nz. Wolters Kluwer in Thought™ Research Reports provide unbiased analysis and ideas based on the needs and direction of clients. Analyses include a proprietary methodology for quantifying probability of FDA approval as well as a forecasting revenue methodology for both approved and developmental drugs and medical devices. The material herein, while not guaranteed, is based upon information believed to be reliable and accurate. in Thought do not: (a) give investment advice; or (b) advocate the sale or purchase of any security or investment. The material herein is not to be deemed an offer or solicitation on our part with respect to the sale or purchase of any securities.

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Correspondence to Ben Weintraub PhD.

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Adapted and reproduced from Weintraub B. Xgeva Ahead of Zometa 2 to 1 in Busy December: Trials Define Anti-Tumor Effects of Anti-Resorptive Agents. inThought Research, 2010 Dec 21

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Weintraub, B. Trials Define Anti-Tumor Effects of Anti-Resorptive Agents. BioDrugs 25, 135–138 (2011). https://doi.org/10.2165/11590730-000000000-00000

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