Phase III Head-to-Head Study of Panitumumab Against Cetuximab in Metastatic Colorectal Cancer Meets Primary Endpoint of Non-Inferiority in Monotherapy Setting

Results of the ASPECCT ('763) trial, a phase III head-to-head study evaluating panitumumab (Vectibix®; Amgen Inc.) versus cetuximab (Erbitux®; ImClone LLC/Eli Lilly and Company and Bristol-Myers Squibb Company) as a single agent for the treatment of chemorefractory metastatic colorectal cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (panitumumab/cetuximab) was 0.966 (95% CI: 0.839, 1.113) favoring the panitumumab arm.

Panitumumab is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC), 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]

Trial Design
ASPECCT is a global, randomized, parallel assignment, open-label, Phase III non-inferiority trial designed to compare the effect of panitumumab versus cetuximab 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 panitumumab every 14 days or 400 mg/m2 of an initial dose of intravenous cetuximab followed by 250 mg/m2 of intravenous cetuximab every seven days.

Adverse events
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.

In Europe, the ASPECCT trial is a Specific Obligation for panitumumab as part of the European Medicine Agency's (EMA) conditional marketing authorization.  Detailed safety and efficacy data will be submitted for presentation at an upcoming medical meeting later this year.

For more information:
[1] Cancer Facts and Figures 2013. American Cancer Society. Last accessed March 25, 2013.
[2] Colorectal Cancer Prevention (PDQ®). National Cancer Institute. Last accessed March 25, 2013.
[3] Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global Cancer Statistics. CA Cancer J Clin. 2011;61:69-90.

Clinical trials
[A] NCT01001377 - ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer.

Copyright © 2013 InPress Media Group/Sunvalley Communication. All rights reserved. Republication or redistribution of InPress Media Group/Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group/Sunvalley Communication. InPress Media Group/Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco'Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.

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Tags: ASPECCT, Cancer, Cetuximab, EGFR, Erbitux, KRAS, Vectibix, anti-EGFR, colorectal, hypomagnesemia, More…mCRC, panitumumab

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