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|Amgen Announces Top-Line Results of Vectibix® (panitumumab) Phase 3 Head-to-Head Study Against Erbitux® (cetuximab) in Metastatic Colorectal Cancer|
Overall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia.
Colorectal cancer is the third most common cancer found in both men and women in the U.S., and is the second leading cause of cancer deaths.1, 2 Approximately 1.2 million cases of colorectal cancer are expected to occur globally.3
Detailed safety and efficacy data will be submitted for presentation at an upcoming medical meeting later this year.
ASPECCT ('763) Trial Design
ASPECCT is a global, randomized, parallel assignment, open-label, Phase 3 non-inferiority trial designed to compare the effect of Vectibix versus Erbitux on overall survival for monotherapy treatment of chemorefractory mCRC in 1,010 patients with wild-type KRAS tumors (primary endpoint). Secondary endpoints included safety, patient reported outcomes, progression-free survival, time to response, time to treatment failure and duration of response.
Patients were randomized in a 1:1 ratio to receive 6 mg/kg of intravenous Vectibix every 14 days or 400 mg/m2 of an initial dose of intravenous Erbitux followed by 250 mg/m2 of intravenous Erbitux every seven days.
Vectibix is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the
Important U.S. Product Information
Vectibix is indicated as a single agent for the treatment of EGFR-expressing, mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibix is not indicated for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown. Retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13.
WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
Infusion Reactions: Severe infusion reactions occurred in approximately one percent of patients. Fatal infusion reactions occurred in postmarketing experience. [See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].
The most common adverse reactions (≥ 20 percent) of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, diarrhea, including diarrhea resulting in dehydration.
The most serious adverse reactions of Vectibix are pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.
Important European Product Information
To see the full Vectibix Safety Information, visit www.vectibix.com.
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The the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the
Erbitux® is a registered trademark of