Fight disease progression with GLIVEC 800 mg/day1-4

  • Dose escalation following progression is the recommended next step in advanced GIST1-3*
  • Dose escalation to GLIVEC 800 mg/day is recommended for patients experiencing progression on 400-mg therapy1-3*
  • Dose escalation prior to switching therapies retains future therapeutic options1,2
Progressive KIT+ GIST: recommended sequence of treatment options1,2
  • At initial progression, a switch from imatinib to sunitinib should be considered only if imatinib causes life-threatening side effects that cannot be managed by maximum supportive treatment1
  • Surgical resection of progressing lesions should be considered, if appropriate1,2

About 1 in 3 patients with metastatic KIT+ GIST benefited from dose escalation with GLIVEC5

Many patients with progression achieve disease control with GLIVEC 800 mg/day.5†

  • 31% of patients in a Phase 3 unresectable and/or metastatic study who dose-escalated to 800 mg/day after progression at 400 mg/day achieved stable disease or partial response6
    ─Median progression-free survival after crossover to 800 mg/day was 5 months (95% CI, 2-10 months)6
    ─Patients who tolerated the 400-mg dose prior to dose escalation were less likely to require dose reductions at the 800-mg level than patients initiated at the higher dose5

GLIVEC has demonstrated efficacy in advanced KIT+ GIST, regardless of mutational status7

  • Approximately 95% of GISTs are KIT+, and the vast majority have activating mutations in the KIT or PDGFRA genes8
    ─ Relative frequencies of GISTs with KIT exon 11 and exon 9 mutations are 68% and 10%, respectively9
    ─ 95% of tumours with KIT exon 9 mutations are in the small bowel8
  • KIT exon 11 and 9 mutations are responsive to GLIVEC therapy7
    ─ 93% of assessable patients with KIT exon 11 mutations achieved disease control, with 72% showing objective response in a large Phase 3 study7†
    ─ 89% of assessable patients with KIT exon 9 mutations achieved disease control, with 44% showing objective response in the same study7†
  • In advanced KIT+ GIST, ESMO guidelines recommend GLIVEC 800 mg/day upon confirmation of exon 9 mutation2
    ─ In a meta-analysis of two large Phase 3 dosing studies for GLIVEC, patients with KIT exon 9 mutations treated with GLIVEC 800 mg/day (n=49) had a 42% reduction (P=0.017) in the estimated risk of progression vs similar patients treated with 400 mg/day (n=42)10
* Based on current guidelines from the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network® (NCCN®).
†Disease control is defined as complete response, partial response, or stable disease.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2016. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed September 21, 2016. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 2. The ESMO/European Sarcoma Network Working Group. Gastrointestinal stromal tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):ii21-ii-26. 3. Reichardt P, Blay J-Y, von Mehren M. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010;10(2):221-232. 4. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2016. 5. Patel S, Zalcberg JR. Optimizing the dose of imatinib for treatment of gastrointestinal stromal tumours: lessons from the phase 3 trials. Eur J Cancer. 2008;44(4):501-509. 6. Blanke CD, Rankin C, Demetri GD, et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the Kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008;26(4):626-632. 7. Heinrich MC, Owzar K, Corless CL, et al. Correlation of kinase genotype and clinical outcome in the North American intergroup phase III trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB 150105 study by Cancer and Leukemia Group B and Southwest Oncology Group. J Clin Oncol. 2008;26(33):5360-5367. 8. Corless CL, Fletcher JA, Heinrich MC. Biology of gastrointestinal stromal tumors. J Clin Oncol. 2004;22(18):3813-3825. 9. Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol. 2008;3:557-586. 10. Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28(7):1247-1253.