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Ramucirumab imc 1121 b ottobre 2010

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COOL - Community in Oncology On Lung Cancer

COOL - Community in Oncology On Lung Cancer

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Ramucirumab imc 1121 b ottobre 2010 Presentation Transcript

  • 1. Angiogenesis inhibitors in clinical development for NSCLC : approaches to targeting VEGF or VEGFRs Giaccone G. The potential of antiangiogenic therapy in non-small cell lung cancer. Clin Cancer Res. 2007 Apr 1;13(7):1961-70.
  • 2. Ramucirumab (IMC-1121B), a fully human IgG1 monoclonal antibody, targets VEGFR2 s-s VEGF- B 167 VEGF- B 186 PlGF- 1,2 VEGF- A 121 VEGF- A 145 VEGF- A 165 VEGF- A 189 VEGF- A 206 VEGF- C VEGF- D VEGFR1 (Flt-1) VEGFR2 (Flk-1/KDR) VEGFR3 (Flt-4) NRP-1 s-s NRP-2 IMC-1121B Vasculogenesis Angiogenesis Angiogenesis Lymphangiogenesis www.researchvegf.com Youssoufian H, Hicklin DJ, Rowinsky EK. Review: monoclonal antibodies to the vascular endothelial growth factor receptor-2 in cancer therapy. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5544s-5548s.
  • 3. Studies of ramucirumab in NSCLC Ongoing trials www.clinicaltrials.gov (accessed on Aug 28 th , 2010) Study ID Ph Eligibility/Line Arm(s) N (projected) NCT00735696 II Stage IIIB or IV (AJCC 6th ed.), first line
    • IMC-1121B + paclitaxel + carboplatin
    40 NCT01160744 II Stage IV , first line
    • IMC-1121B + Premetrexed + Carboplatin or Cisplatin
    • Premetrexed + Carboplatin or Cisplatin
    • IMC-1121B + Gemcitabine + Carboplatin or Cisplatin
    • Gemcitabine + Carboplatin or Cisplatin
    280 NCT01168973 III Stage IV, second line
    • Docetaxel + Ramucirumab
    • Docetaxel + Placebo
    1156
  • 4. NCT00735696 - Phase 2 study in NSCLC (1 st -line: IMC-1121B + paclitaxel/carboplatin) Preliminary results shown at ASCO 2010 Camidge et al. ASCO (Poster) June 2010 D. R. Camidge, M. S. Ballas, S. Dubey, M. Haigentz, P. J. Rosen, J. F. Spicer, H. J. West, G. D. Shah, H. Youssoufian, A. C. Mita. A phase II, open-label study of ramucirumab (IMC-1121B), an IgG1 fully human monoclonal antibody (MAb) targeting VEGFR-2, in combination with paclitaxel and carboplatin as first-line therapy in patients (pts) with stage IIIb/IV non-small cell lung cancer (NSCLC). J Clin Oncol 28:15s, 2010 (suppl; abstr 7588) Patient Characteristics (n=35) Gender: male 35% , female 65% Performance Status : ECOG 0 38% , ECOG 1 62% Histology : adenocarcinoma w focal squamous 3%, adenocarcinoma97% Ramucirumab-related AEs in at Least 10% of Pts Across All Grades (N=35)
  • 5. Waterfall Plot of Percent Change of Target Lesions from Baseline per RECIST v1.0 (from 28 pts*) Response by RECIST v1.0 (N=29 evaluable pts) NCT00735696 - Phase 2 study in NSCLC (1 st -line: IMC-1121B + paclitaxel/carboplatin) Preliminary results shown at ASCO 2010 (cont’d) Camidge et al. ASCO (Poster) June 2010 D. R. Camidge, M. S. Ballas, S. Dubey, M. Haigentz, P. J. Rosen, J. F. Spicer, H. J. West, G. D. Shah, H. Youssoufian, A. C. Mita. A phase II, open-label study of ramucirumab (IMC-1121B), an IgG1 fully human monoclonal antibody (MAb) targeting VEGFR-2, in combination with paclitaxel and carboplatin as first-line therapy in patients (pts) with stage IIIb/IV non-small cell lung cancer (NSCLC). J Clin Oncol 28:15s, 2010 (suppl; abstr 7588) ♦ This pt had PD based on a new lesion ♠ These 2 pts had an unconfirmed PR because confirmatory scans have not yet been performed * This plot was based on 28 pts with evaluable target lesions. There was 1 pt who had no follow-up target lesion measurements that were available in the clinical database and therefore is not presented in this plot; however, the Investigator considered the pt as SD at the time of this report.
  • 6. Randomized Phase 3 Study in NSCLC Docetaxel +/- IMC-1121B www.clinicaltrials.gov ; NCT01168973; accessed on Aug 28 th , 2010
    • NSCLC stage IV progressing during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy
    • All histologies
    • ECOG PS <=1
    R A N D O M I Z E Docetaxel 75 mg/m 2 q3w + IMC-1121B 10 mg/kg q3w Treat until PD, toxicity, consent withdrawal 2 1 Docetaxel 75 mg/m 2 q3w + Placebo
  • 7.