Navigation Links
Two Pivotal Vectibix® Phase 3 Studies in First and Second-Line Treatment of Metastatic Colorectal Cancer Published in the Journal of Clinical Oncology
Date:10/4/2010

er (median 14.5 months versus 12.5 months; hazard ratio 0.85; 95 percent CI: 0.70-1.04), the improvement in overall survival (co-primary endpoint) in the Vectibix arm did not achieve statistical significance (p=0.12) in the same patient population.
  • The addition of Vectibix to chemotherapy in the '181' trial resulted in greater than a three-fold improvement (35 percent versus 10 percent) in response rate in the wild-type KRAS patient population, as measured by a blinded central review.
  • Tumor KRAS status was ascertained in 91 percent of the 1,186 patients enrolled in the '181' trial, the highest number ever prospectively reported for a second-line trial.
  • In this study, the addition of Vectibix had no positive or negative effect on PFS or OS in patients with tumors harboring activating KRAS mutations.

  • "The response rate seen in the '181' trial is among the highest ever reported in the second-line metastatic colorectal cancer setting," said Emily Chan, M.D., Ph.D., Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center and '181' study investigator and author. "Additionally, the tissue acquisition from both the '181' and '203' studies has yielded a large repository of informative data regarding the KRAS biomarker, and holds the potential of providing even more information in the future."

    In general, adverse events rates were comparable across arms in both studies, with the exception of known toxicities associated with anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients.

    Originally designed to compare the treatment effect in the overall mCRC patient population, both studies were amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. These are the first Phase 3 studies to prospectively analyze the effect of
    '/>"/>

    SOURCE Amgen
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10 11

    Related biology technology :

    1. NovaRx Initiates Pivotal Phase III Clinical Trial in Lung Cancer Patients
    2. Positive SPA Reply From the FDA for TopoTargets Pivotal Trial With Belinostat in PTCL
    3. Fifth DuraHeart(TM) U.S. Implant Marks Important Milestone in U.S. Pivotal Trial
    4. Oncolytics Biotech Inc. Announces Decision to Pursue Phase II/III Pivotal Clinical Trial
    5. Genmab A/S: Ofatumumab Pivotal CLL Data to be Presented at ASH
    6. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point
    7. BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009
    8. BioSyntech Achieves Enrolment Goal for Pivotal Trial of BST-CarGel(R), its Cartilage Repair Device
    9. ExonHit Therapeutics Invested Strongly in 2008 for Pivotal 2009 Results
    10. PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
    11. BioMS Medicals pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:7/10/2014)... Utah , July 10, 2014 /PRNewswire-iReach/ ... annotation and interpretation, today announced an agreement ... (NGS) analytics for Lineagen,s NextStep Dx ... of neurodevelopmental and neurological disorders, currently offers ... microarray (CMA) testing service used by healthcare ...
    (Date:7/10/2014)... THOUSAND OAKS, Calif., July 10, 2014   Ceres, ... biotechnology and seed company, announced today financial results for ... an update on its business. Ceres reported ... progress in product performance this growing season in Brazil, ... that affected the company,s sorghum evaluation areas for part ...
    (Date:7/10/2014)... the fight against terrorism with the creation of a ... the use of light and special glass fibres. , ... Chemical , the researchers describe a novel optical fibre ... as 6.3 ppm (parts per million). It requires an ... explosives detection has involved looking for metals that encase ...
    (Date:7/10/2014)... in the journal PNAS (Proceedings of the National ... day and sleep deprivation have a significant effect on ... at the best time of day to test for ... administering medicines effectively. , Researchers from the University of ... the links between sleep deprivation, body clock disruption and ...
    Breaking Biology Technology:Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 2Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 3Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test 4Ceres Announces Fiscal Third Quarter 2014 Financial Results 2Ceres Announces Fiscal Third Quarter 2014 Financial Results 3Ceres Announces Fiscal Third Quarter 2014 Financial Results 4Ceres Announces Fiscal Third Quarter 2014 Financial Results 5Ceres Announces Fiscal Third Quarter 2014 Financial Results 6Ceres Announces Fiscal Third Quarter 2014 Financial Results 7Ceres Announces Fiscal Third Quarter 2014 Financial Results 8Ceres Announces Fiscal Third Quarter 2014 Financial Results 9Detecting trace amounts of explosives with light 2Time of day crucial to accurately test for diseases, new research finds 2
    ... Immucor, Inc. (Nasdaq:,BLUD), a global leader in providing automated instrument-reagent ... the fiscal year ending May 31, 2009., For fiscal ... $292 million to $300 million., -- ... to 71%., -- Net income is expected to be in ...
    ... DANBURY, Conn., June 4 Biodel Inc. (Nasdaq:,BIOD) today ... Corporate Development and Treasurer of Biodel, will present a,corporate ... on,Friday, June 6, 2008 at 1:40 p.m. Pacific Daylight ... San Francisco., Interested parties may access a link ...
    ... held in ... Georgia, ATLANTA, June 4 ... 17 -- 20, in,San Diego, Calif. Governor Perdue will deliver remarks on June ... of the fastest-growing industries in the nation, the,biosciences sector is a strategic priority ...
    Cached Biology Technology:Immucor Announces Fiscal Year 2009 Revenue and Earnings Guidance 2Immucor Announces Fiscal Year 2009 Revenue and Earnings Guidance 3Georgia Showcases its Bioscience Leadership at 2008 Bio International Convention 2Georgia Showcases its Bioscience Leadership at 2008 Bio International Convention 3
    (Date:7/10/2014)... open ocean as a microbial megacity, teeming with life ... water, hundreds of types of bacteria can be found. ... ocean microbes have their own daily cyclesnot unlike the ... up, commute, work, and eat at the same times., ... photoautotrophsbacteria that need solar energy to help them photosynthesize ...
    (Date:7/10/2014)... if you are a big, bad sea scorpion. , ... waters for any prey in sight. The next, thanks ... you,re reduced to trolling for weaker, soft-bodied animals you ... of the giant pterygotid eurypterid, the largest arthropod that ... in the journal Biology Letters , dramatically re-interprets ...
    (Date:7/10/2014)... JUPITER, FL, July 10, 2014 Amidst the astounding ... of synaptic connections in the brain, how do nerve ... connections to build? How do they coordinate these events ... scientists from the Florida campus of The Scripps Research ... processes, showing that a particular protein plays a far ...
    Breaking Biology News(10 mins):New research finds ocean's most abundant organisms have clear daily cycles 2New research finds ocean's most abundant organisms have clear daily cycles 3Extinct sea scorpion gets a Yale eye exam, with surprising results 2Scripps Florida scientists shed new light on nerve cell growth 2
    ... FAHA, the Aram V. Chobanian Professor of Cardiovascular ... at Boston University School of Medicine (BUSM), has ... Distinguished Scientist. The AHA designated only five Distinguished ... Distinguished Scientist designation in 2003 to recognize science ...
    ... at Boston University School of Medicine (BUSM) have brought attention ... and their infants from consuming brown seaweed soup. Seaweed is ... there is no scientific data on the iodine content in ... Editor for the journal Thyroid and published online, ...
    ... What looks like a spongy ball wrapped in strands ... be key to unlocking better methods for catalysis, artificial ... University chemists who have created a platform to analyze ... photoluminescent materials. The microscopic particles assembled in ...
    Cached Biology News:BUSM professor selected as American Heart Association Distinguished Scientist 2BUSM researchers urge awareness of dietary iodine intake in postpartum Korean-American women 2Supramolecules get time to shine 2Supramolecules get time to shine 3
    ... Salmonella genomes has allowed the development of ... pairs. The S. enterica Typhimurium (strain LT2) ... bp; 4,440 ORFs) and a plasmid, pSLT ... Sigma-Genosys have been designed to amplify all ...
    ... The Bio-Stack Twister II Microplate ... top automation solution for integrating BioTeks ... together with expandable microplate capacity, ultimate ... Whether you are adding capacity to ...
    XPLAC (S-17)...
    Request Info...
    Biology Products: