Amgen to Present Pivotal Data From Four Phase 3 Studies at the ECCO 15 – ESMO 34 Congress
THOUSAND OAKS, Calif., Sept. 16 /PRNewswire-FirstCall/ — Amgen (Nasdaq: AMGN) today announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 – ESMO 34 European Multidisciplinary Congress, September 20 – 24, 2009 in Berlin, Germany.
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).
“Amgen is very pleased to be presenting these important data from the denosumab and Vectibix development programs,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “The data from these trials demonstrate that both denosumab and Vectibix have the potential to improve outcomes in patients suffering from cancer.”
SELECTED ABSTRACTS OF INTEREST
Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.
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 Congress on September 24th, at 6:30 a.m. ET to discuss data presented at ECCO-ESMO. A webcast of the event can be found on Amgen’s Web site at www.amgen.com, under Investors. The audio webcast will be archived and available for replay for at least 72 hours.
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 Amgen. This broad and deep development program demonstrates Amgen’s commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and destruction associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer.
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 U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the United States in September 2006 as a monotherapy for the treatment of patients with EGFR expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS genes after failure of standard chemotherapy regimens. Vectibix has been launched in over 20 countries, including Switzerland, Australia and Canada. Applications in the rest of the world are pending.
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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