Olaratumab imc 3 g3 ottobre 2010

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COOL - Community in Oncology On Lung Cancer

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Olaratumab imc 3 g3 ottobre 2010

  1. 1. www.esanum.it/cool The Platelet-Derived Growth Factor (PDGF) Family of Ligands and Receptors, and PDGFRα Signaling Pathways Östman A, Heldin C-H. Adv Cancer Res. 2007;97:247-274; Loizos N et al. Mol Cancer Ther. 2005;4:369-379; Schmitt J, Matei D. Clin Ovarian Cancer. 2008;1:120-126;Imclone Systems, Data on File. PDGFRa is overexpressed in multiple tumor types, including lung, with expression being associated to aggressive phenotypes and increased metastasis PDGFRα is expressed in both tumor and stromal cells
  2. 2. www.esanum.it/cool Olaratumab (IMC-3G3) is a fully human IgG1 monoclonal antibody targeted against platelet-derived growth factor receptor-α (PDGFRα) Loizos N et al. Mol Cancer Ther. 2005;4:369-379; ImClone Systems. Data on file; Matei D et al. Oncogene 2006;25:2060-2069; Youssoufian H et al. J Clin Oncol. 2008;26:15s. Abstract 14617; Östman A, Heldin C-H. Adv Cancer Res. 2007;97:247-274; Schmitt J, Matei D. Clin Ovarian Cancer. 2008;1:120-126. In preclinical studies: Binds to PDGFRα with high affinity; Kd=40 pM Blocks receptor activation in tumor and stromal cells Inhibits activation of downstream effector molecules May cause anticancer activity by directly inhibiting tumor growth inhibiting angiogenesis and the surrounding tumor milieu
  3. 3. www.esanum.it/cool Studies of olaratumab in NSCLC Ongoing trials Study ID Ph Eligibility/Line Arm(s) N (projected) NCT00918203 II Stage IIIB/IV, first line  Paclitaxel + Carboplatin  IMC-3G3 + Paclitaxel + Carboplatin 136 www.clinicaltrials.gov (accessed on August 28th, 2010)
  4. 4. www.esanum.it/cool A Randomized Phase 2 Study of IMC-3G3 With or Without Carboplatin and Paclitaxel in Patients With Previously Untreated Locally Advanced or Metastatic NSCLC • NSCLC stage IIIB or IV • No prior chemotherapy or targeted therapy in the metastatic setting • Squamous histology eligible • CNS metastases allowed • Age ≥18 • ECOG performance status ≤1 R A N D O M I Z E IMC-3G3 IMC-3G3 15 mg/kg day 1, 8 + Taxol 200 mg/m2 day 1 + Carboplatin AUC=6 day 1 every 3 weeks x 6 Paclitaxel 200 mg/m2 day 1 + Carboplatin AUC=6 day 1 every 3 weeks x 6 N=136 Primary Objective: PFS www.clinicaltrials.gov; NCT00918203 (accessed on August 28th, 2010) 4
  5. 5. www.esanum.it/cool
  6. 6. www.esanum.it/cool

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