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Amgen to Present Pivotal Data From Four Phase 3 Studies at the ECCO 15 - ESMO 34 Congress
Researchers will present data from two Phase 3 head-to-head studies evaluating denosumab versus Zometa(R) (zoledronic acid) for the treatment of bone metastases in patients with advanced breast cancer (the '136' study) and the treatment of bone metastases in advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma (the '244' study).
Detailed data will also be presented from two Phase 3 studies evaluating Vectibix(R) (panitumumab) in combination with chemotherapy for the first-line and second-line treatment of metastatic colorectal cancer (the '203' and '181' trials, respectively).
SELECTED ABSTRACTS OF INTEREST
Identified below are selected abstracts of interest on
Denosumab -- A double-blind, randomized study of denosumab versus zoledronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma Lead Author: Henry, D. Abstract No. 20LBA (
Monday, Sept. 21, 2009, 12:45 -13:00 CEST) -- Denosumab versus zoledronic acid for the treatment of breast cancer patients with bone metastases: Results of a randomized Phase 3 study Lead Author: Stopeck, A. Abstract No. 2LBA ( Tuesday, Sept. 22, 2009, 14:15 - 14:30 CEST) -- Overall survival in men with and without prevalent vertebral fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer Lead Author: Smith, M. Abstract No. 7005 ( Monday, Sept. 21, 2009, 12:15 -12:45 CEST) Vectibix -- Randomized Phase 3 study of panitumumab with FOLFIRI vs FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC) Lead Author: Peeters, M. Abstract No. 14LBA ( Tuesday, Sept. 22, 2009, 10:45 - 11:00 CEST) -- Randomized Phase 3 study of panitumumab with FOLFOX compared to FOLFOX alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): The PRIME trial Lead Author: Douillard, J.Y. Abstract No. 10LBA ( Thursday, Sept. 24, 2009, 11:00 - 11:15 CEST)
An analyst/investor event will also be held from the
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19,000 patients in trials across indications worldwide, the denosumab development program is the largest ever initiated by
In two phase 3 skeletal related events studies reported to date, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for denosumab and Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in both treatment groups.
Vectibix is the first fully human anti-EGFR approved by the
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix has not shown a treatment benefit for patients whose tumors had KRAS mutations in codon 12 or 13.
Important Product Safety Information
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to lesser than or equal to grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.
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