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Aug 9, 2012

Amgen Anticancer Antibody Bites the Dust

  • Amgen has pulled the plug on its IGF1R monoclonal antibody candidate ganitumab, after an interim analysis of an ongoing Phase III study failed to show any benefits of combining the drug with gemcitabine therapy in patients with metastatic pancreatic cancer. Discontinuing development of ganitumab means the firm will stop both the ongoing Phase III Gamma study and a separate Phase II study in patients with locally advanced pancreatic cancer.

    The firm’s anticancer antibody pipeline is now headed by the Phase III-stage EGFR pathway antagonist Vectibix® (panitumumab), and the RANKL-targeting antibody Xgeva (denosumab), which is in development for preventing the development of bone metastases in prostate and breast cancers. Vectibix is also undergoing Phase II development for the treatment of locally advanced head and neck cancer, and Xgeva is in Phase II trials against giant cell tumor of the bone.

    Amgen’s Phase II-stage anticancer antibody candidates include rilotumumab, a fully human mAb against hepatocyte growth factor/scatter factor, and AMG888, a Her3 signalling inhibitor in development in partnership with Daiichi Sankyo.

    Vectibix is already approved as a single agent treatment for epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal carcinoma that has progressed despite chemotherapy. Denosumab is approved for treating postmenopausal women with osteoporosis at high risk for fracture, for preventing skeletal-related events (SREs) in patients with bone metastases from solid tumors, and as a treatment for increasing bone mass in patients who are at high risk of fracture from as a result of receiving androgen deprivation therapy for nonmetastatic prostate cancer, or adjuvant aromatase inhibitor therapy for breast cancer.

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