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New therapeutic approaches in lung cancer

New therapeutic approaches in lung cancer. Dr Marc Lambrechts. Anti-cancer strategies for NSCLC today. Traditional therapies. Targeted therapies. Adjuvant chemotherapy improves survival in early stage NSCLC. Addition of targeted therapies to 1 st -line chemotherapy.

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New therapeutic approaches in lung cancer

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  1. New therapeutic approaches in lung cancer Dr Marc Lambrechts

  2. Anti-cancer strategies for NSCLC today Traditional therapies Targeted therapies Adjuvant chemotherapy improves survival in early stage NSCLC Addition of targeted therapies to 1st-line chemotherapy Use of EGFR tyrosine kinase inhibitors in advanced disease Chemo-radiotherapy improves survival in advanced NSCLC Targeted populations Modest but significant benefits Significant side-effects Has reached plateau There is a need for new treatment options that prolong survival and improve quality of life in this group of patients

  3. Immunotherapy Immunotherapy The immune system Activates natural immune system Body’s natural defence mechanism Recognises foreign and harmful agents (e.g. viruses, bacteria, etc) Helps body identify cancer cells Boosts immune response against cancer Initiates response to eliminate potential threats

  4. Rationale for therapeutic cancer vaccines • Evidence for the ability of the immune system to recognize tumors • Wide range of newly identified potential tumor targets • Favourable toxicity profile • Possible immuno-stimulating effects of existing therapies Preventive cancer vaccines Therapeutic cancer vaccines Used BEFORE the disease is established Used AFTER the disease is established Stimulate the immune system to target CANCER cells Stimulate the immune system to target INFECTIOUS agents Used to PREVENT the disease Used to TREAT the disease Echchakir H, et al. Int Immunol 2000;12:537–546Wei YQ, et al. Immunol Invest 1989;18:1095–1105

  5. MUC1 MAGE-A3 GD3 Identifying a vaccine target/antigen Tumor antigens in lung cancer MUC1 tumor antigen Associated with increased risk of disease progression and poor prognosis Suppresses immune cell function Can prevent anti-tumor immune response

  6. MUC1 expression in lung cancer

  7. Lung cancer vaccine trials Results 917 studies with “cancer vaccines” 59 studies in NSCLC 22 studies active 3 agents in Phase III trials BLP25 Liposome Vaccine (START trial) MAGE-A3 (MAGRIT trial) Belagenpumatucel-L (STOP trial)

  8. Phase III therapeutic cancer vaccine trials in NSCLC Antigen • Antigenic MUC1 peptide Vaccine containing a synthetic antigen, designed to stimulate the immune system against cells containing that antigen. BLP25 Liposome Vaccine BLP25 Liposome Vaccine is currently under clinical investigation and has not been approved for use in the US, Europe, Canada, or elsewhere. BLP25 has not been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labelled claims

  9. Most adverse events were disease related and unrelated to the study drug Mild-to-moderate flu-like symptoms and injection site redness (i.e. cough, fatigue, nausea,vomiting, diarrhea) Ten patients have been treated for up to 8.2 years and eight are still being treated BLP25 Phase II results: Stage IIIb locoregional patients Overall survival Safety results In a subset of patients, BLP25 showed more than a doubling of the median survival time from 13.3 to 30.6 months and a favorable tolerability profile. Butts C, et al. J Clin Oncol 2005;23:6674–6681; Butts C, et al. J Thorac Oncol 2007;2(Suppl 4):S332-S333. Abstract No: B1-01.

  10. Phase III therapeutic cancer vaccine trials in NSCLC Antigen • Purified MAGE-A3 protein Vaccine containing a synthetic antigen, designed to stimulate the immune system against cells containing that antigen. BLP25 Liposome Vaccine MAGE-A3 Immunotherapeutic

  11. MAGE-A3 Phase II results Disease-free survival Overall survival HR = 0.73 (95% CI 0.45-1.16)one-sided logrank p = 0.093 HR = 0.66 (95% CI 0.36-1.20)one-sided logrank p = 0.088 MAGE-A3 immunotherapeutic showed a trend toward increasing overall and disease-free survival compared to placebo.

  12. Phase III therapeutic cancer vaccine trials in NSCLC Antigen • Tumor cells from four irradiated NSCL cancer cell lines Genetically engineered to inhibit TGF-β2 which plays a role in suppressing the immune system. BLP25 Liposome Vaccine MAGE-A3 Immunotherapeutic Belagenpumatucel-L

  13. Belagenpumatucel-LPhase II results Radiographic evidence Overall survival (n=61, p=0.0186) Pre-therapy Post-therapy Belagenpumatucel-L showed a positive effect on overall survival and tumor response as shown by the radiographic evidence.

  14. Phase III vaccine trials in NSCLC START trial MAGRIT trial STOP trial BLP25 MAGE-A3 Belagenpumatucel-L Resected patients with stage Ib, II or IIIa, MAGE-A3 positive NSCLC Patients with unresectable stage III NSCLC following chemoradiotherapy Patients with Stage IIIa or IIIb/IV NSCLC that respond to 1st-line therapy 700 patients 2,270 patients 1,322 patients BLP25 + BSC MAGE-A3 Vaccine + BSC or or or Placebo + BSC Placebo + BSC Placebo 1ry Objective 1ry Objective 1ryObjective PFS OS PFS + OS http://www.clinicaltrials.gov/ct2/show/NCT00409188; http://www.clinicaltrials.gov/ct2/show/NCT00409188; http://clinicaltrials.gov/ct2/show/NCT00676507?term=Lucanix&rank=1

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