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  • Introduction & ObjectivesCisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy is widely recommended for muscle-invasive bladder cancer (MIBC). There is no clear survival benefit for AC. Atezolizumab (atezo; MPDL3280A) is an anti-PDL1 antibody that inhibits the binding of PD-L1 to PD-1 and B7-1. Atezo demonstrated a 50% unconfirmed response rate and manageable safety profile in patients (pts) with metastatic BC with higher levels of PD-L1 expression on tumor-infiltrating immune cells (IC; Petrylak, ASCO 2015, abstract 4501). Therefore, there is a strong rationale to test atezo in the adjuvant setting. IMvigor 010 (NCT02450331) is a Phase III open-label, multicenter, randomized, controlled study to evaluate the efficacy and safety of atezo adjuvant treatment compared with observation in pts with PD-L1−selected MIBC who are at high risk for recurrence following cystectomy.Material & MethodsPts will be randomized 1:1 to receive atezo (1200 mg intravenously every 3 weeks) or undergo observation as adjuvant treatment for up to 1 year. Pts will be stratified by number of lymph nodes resected, nodal status, tumor stage after cystectomy, age-adjusted Charlson Comorbidity Index and prior NAC. Inclusion criteria include histologically or cytologically confirmed MIBC, cystectomy with lymph node dissection and Eastern Cooperative Oncology Group performance status ≤ 2. Pts with prior NAC must have tumour staging of ypT2−T4a or ypN+; pts without prior NAC must be ineligible for or have declined cisplatin-based AC and have tumour staging of pT3−T4a or pN+. PD-L1 expression on IC in cystectomy tumour specimens will be centrally assessed using the SP142 immunohistochemistry (IHC) assay. Pts with a PD-L1 IHC score of IC2/3 (IC ≥ 5% PD-L1+) are eligible. The primary efficacy endpoint is disease-free survival. Secondary efficacy endpoints are overall survival, disease-specific survival and distant metastasis–free survival. The safety objective is to evaluate the safety and tolerability of atezo in the adjuvant setting. The exploratory objective is to assess predictive, prognostic and pharmacodynamic biomarkers. Disease recurrence will be determined by the investigator based on radiographic evidence with the support of available biopsy results. Approximately 440 pts will be enrolled globally. This trial is currently enrolling. For more information on this trial and other ongoing atezo clinical trials, please visit www.ClinicalTrials.gov. Bellmunt J.1, Powles T.2, Hussain M.3, Castellano D.4, Gschwend J.5, Culine S.6, Shen X.7, Nelson B.7, Fine G.7, Albers P.8 7th European Multidisciplinary Meeting on Urological Cancers 1Dana-Farber Cancer Institute, Bladder Cancer Center, Boston, 2Barts Cancer Institute, Queen Mary University of London, London, 3University of Michigan, Dept. of Medical Oncology, Ann Arbor, 4Hospital Universitario 12 De Octubre, Dept. of Oncology, Madrid, 5Technische Universität München, Dept. of Oncology, Munich, 6Hôpital Saint-Louis, Dept. of Oncology, Paris, 7Genentech, Inc., Genentech, Inc., South San Francisco, 8University of Düsseldorf, Dept. of Oncology, Düsseldorf 58565 EMUC15-0077 P099
  • Introduction & ObjectivesCisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy is widely recommended for muscle-invasive bladder cancer (MIBC). There is no clear survival benefit for AC. Atezolizumab (atezo; MPDL3280A) is an anti-PDL1 antibody that inhibits the binding of PD-L1 to PD-1 and B7-1. Atezo demonstrated a 50% unconfirmed response rate and manageable safety profile in patients (pts) with metastatic BC with higher levels of PD-L1 expression on tumor-infiltrating immune cells (IC; Petrylak, ASCO 2015, abstract 4501). Therefore, there is a strong rationale to test atezo in the adjuvant setting. IMvigor 010 (NCT02450331) is a Phase III open-label, multicenter, randomized, controlled study to evaluate the efficacy and safety of atezo adjuvant treatment compared with observation in pts with PD-L1−selected MIBC who are at high risk for recurrence following cystectomy.Material & MethodsPts will be randomized 1:1 to receive atezo (1200 mg intravenously every 3 weeks) or undergo observation as adjuvant treatment for up to 1 year. Pts will be stratified by number of lymph nodes resected, nodal status, tumor stage after cystectomy, age-adjusted Charlson Comorbidity Index and prior NAC. Inclusion criteria include histologically or cytologically confirmed MIBC, cystectomy with lymph node dissection and Eastern Cooperative Oncology Group performance status ≤ 2. Pts with prior NAC must have tumour staging of ypT2−T4a or ypN+; pts without prior NAC must be ineligible for or have declined cisplatin-based AC and have tumour staging of pT3−T4a or pN+. PD-L1 expression on IC in cystectomy tumour specimens will be centrally assessed using the SP142 immunohistochemistry (IHC) assay. Pts with a PD-L1 IHC score of IC2/3 (IC ≥ 5% PD-L1+) are eligible. The primary efficacy endpoint is disease-free survival. Secondary efficacy endpoints are overall survival, disease-specific survival and distant metastasis–free survival. The safety objective is to evaluate the safety and tolerability of atezo in the adjuvant setting. The exploratory objective is to assess predictive, prognostic and pharmacodynamic biomarkers. Disease recurrence will be determined by the investigator based on radiographic evidence with the support of available biopsy results. Approximately 440 pts will be enrolled globally. This trial is currently enrolling. For more information on this trial and other ongoing atezo clinical trials, please visit www.ClinicalTrials.gov. Bellmunt J.1, Powles T.2, Hussain M.3, Castellano D.4, Gschwend J.5, Culine S.6, Shen X.7, Nelson B.7, Fine G.7, Albers P.8 7th European Multidisciplinary Meeting on Urological Cancers 1Dana-Farber Cancer Institute, Bladder Cancer Center, Boston, 2Barts Cancer Institute, Queen Mary University of London, London, 3University of Michigan, Dept. of Medical Oncology, Ann Arbor, 4Hospital Universitario 12 De Octubre, Dept. of Oncology, Madrid, 5Technische Universität München, Dept. of Oncology, Munich, 6Hôpital Saint-Louis, Dept. of Oncology, Paris, 7Genentech, Inc., Genentech, Inc., South San Francisco, 8University of Düsseldorf, Dept. of Oncology, Düsseldorf 58565 EMUC15-0077 P099

    Session: Oral presentations of the best abstracts

    Location: Saturday, 14 November 2015, 08:50 - 09:30, Auditorium

  • Introduction & ObjectivesCisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy is widely recommended for muscle-invasive bladder cancer (MIBC). There is no clear survival benefit for AC. Atezolizumab (atezo; MPDL3280A) is an anti-PDL1 antibody that inhibits the binding of PD-L1 to PD-1 and B7-1. Atezo demonstrated a 50% unconfirmed response rate and manageable safety profile in patients (pts) with metastatic BC with higher levels of PD-L1 expression on tumor-infiltrating immune cells (IC; Petrylak, ASCO 2015, abstract 4501). Therefore, there is a strong rationale to test atezo in the adjuvant setting. IMvigor 010 (NCT02450331) is a Phase III open-label, multicenter, randomized, controlled study to evaluate the efficacy and safety of atezo adjuvant treatment compared with observation in pts with PD-L1−selected MIBC who are at high risk for recurrence following cystectomy.Material & MethodsPts will be randomized 1:1 to receive atezo (1200 mg intravenously every 3 weeks) or undergo observation as adjuvant treatment for up to 1 year. Pts will be stratified by number of lymph nodes resected, nodal status, tumor stage after cystectomy, age-adjusted Charlson Comorbidity Index and prior NAC. Inclusion criteria include histologically or cytologically confirmed MIBC, cystectomy with lymph node dissection and Eastern Cooperative Oncology Group performance status ≤ 2. Pts with prior NAC must have tumour staging of ypT2−T4a or ypN+; pts without prior NAC must be ineligible for or have declined cisplatin-based AC and have tumour staging of pT3−T4a or pN+. PD-L1 expression on IC in cystectomy tumour specimens will be centrally assessed using the SP142 immunohistochemistry (IHC) assay. Pts with a PD-L1 IHC score of IC2/3 (IC ≥ 5% PD-L1+) are eligible. The primary efficacy endpoint is disease-free survival. Secondary efficacy endpoints are overall survival, disease-specific survival and distant metastasis–free survival. The safety objective is to evaluate the safety and tolerability of atezo in the adjuvant setting. The exploratory objective is to assess predictive, prognostic and pharmacodynamic biomarkers. Disease recurrence will be determined by the investigator based on radiographic evidence with the support of available biopsy results. Approximately 440 pts will be enrolled globally. This trial is currently enrolling. For more information on this trial and other ongoing atezo clinical trials, please visit www.ClinicalTrials.gov. Bellmunt J.1, Powles T.2, Hussain M.3, Castellano D.4, Gschwend J.5, Culine S.6, Shen X.7, Nelson B.7, Fine G.7, Albers P.8 7th European Multidisciplinary Meeting on Urological Cancers 1Dana-Farber Cancer Institute, Bladder Cancer Center, Boston, 2Barts Cancer Institute, Queen Mary University of London, London, 3University of Michigan, Dept. of Medical Oncology, Ann Arbor, 4Hospital Universitario 12 De Octubre, Dept. of Oncology, Madrid, 5Technische Universität München, Dept. of Oncology, Munich, 6Hôpital Saint-Louis, Dept. of Oncology, Paris, 7Genentech, Inc., Genentech, Inc., South San Francisco, 8University of Düsseldorf, Dept. of Oncology, Düsseldorf 58565 EMUC15-0077 P099

    Session: Oral presentations of the best abstracts

    Location: Saturday, 14 November 2015, 08:50 - 09:30, Auditorium

  • Introduction & ObjectivesCisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy is widely recommended for muscle-invasive bladder cancer (MIBC). There is no clear survival benefit for AC. Atezolizumab (atezo; MPDL3280A) is an anti-PDL1 antibody that inhibits the binding of PD-L1 to PD-1 and B7-1. Atezo demonstrated a 50% unconfirmed response rate and manageable safety profile in patients (pts) with metastatic BC with higher levels of PD-L1 expression on tumor-infiltrating immune cells (IC; Petrylak, ASCO 2015, abstract 4501). Therefore, there is a strong rationale to test atezo in the adjuvant setting. IMvigor 010 (NCT02450331) is a Phase III open-label, multicenter, randomized, controlled study to evaluate the efficacy and safety of atezo adjuvant treatment compared with observation in pts with PD-L1−selected MIBC who are at high risk for recurrence following cystectomy.Material & MethodsPts will be randomized 1:1 to receive atezo (1200 mg intravenously every 3 weeks) or undergo observation as adjuvant treatment for up to 1 year. Pts will be stratified by number of lymph nodes resected, nodal status, tumor stage after cystectomy, age-adjusted Charlson Comorbidity Index and prior NAC. Inclusion criteria include histologically or cytologically confirmed MIBC, cystectomy with lymph node dissection and Eastern Cooperative Oncology Group performance status ≤ 2. Pts with prior NAC must have tumour staging of ypT2−T4a or ypN+; pts without prior NAC must be ineligible for or have declined cisplatin-based AC and have tumour staging of pT3−T4a or pN+. PD-L1 expression on IC in cystectomy tumour specimens will be centrally assessed using the SP142 immunohistochemistry (IHC) assay. Pts with a PD-L1 IHC score of IC2/3 (IC ≥ 5% PD-L1+) are eligible. The primary efficacy endpoint is disease-free survival. Secondary efficacy endpoints are overall survival, disease-specific survival and distant metastasis–free survival. The safety objective is to evaluate the safety and tolerability of atezo in the adjuvant setting. The exploratory objective is to assess predictive, prognostic and pharmacodynamic biomarkers. Disease recurrence will be determined by the investigator based on radiographic evidence with the support of available biopsy results. Approximately 440 pts will be enrolled globally. This trial is currently enrolling. For more information on this trial and other ongoing atezo clinical trials, please visit www.ClinicalTrials.gov. Bellmunt J.1, Powles T.2, Hussain M.3, Castellano D.4, Gschwend J.5, Culine S.6, Shen X.7, Nelson B.7, Fine G.7, Albers P.8 7th European Multidisciplinary Meeting on Urological Cancers 1Dana-Farber Cancer Institute, Bladder Cancer Center, Boston, 2Barts Cancer Institute, Queen Mary University of London, London, 3University of Michigan, Dept. of Medical Oncology, Ann Arbor, 4Hospital Universitario 12 De Octubre, Dept. of Oncology, Madrid, 5Technische Universität München, Dept. of Oncology, Munich, 6Hôpital Saint-Louis, Dept. of Oncology, Paris, 7Genentech, Inc., Genentech, Inc., South San Francisco, 8University of Düsseldorf, Dept. of Oncology, Düsseldorf 58565 EMUC15-0077 P099
  • Introduction & ObjectivesCisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy is widely recommended for muscle-invasive bladder cancer (MIBC). There is no clear survival benefit for AC. Atezolizumab (atezo; MPDL3280A) is an anti-PDL1 antibody that inhibits the binding of PD-L1 to PD-1 and B7-1. Atezo demonstrated a 50% unconfirmed response rate and manageable safety profile in patients (pts) with metastatic BC with higher levels of PD-L1 expression on tumor-infiltrating immune cells (IC; Petrylak, ASCO 2015, abstract 4501). Therefore, there is a strong rationale to test atezo in the adjuvant setting. IMvigor 010 (NCT02450331) is a Phase III open-label, multicenter, randomized, controlled study to evaluate the efficacy and safety of atezo adjuvant treatment compared with observation in pts with PD-L1−selected MIBC who are at high risk for recurrence following cystectomy.Material & MethodsPts will be randomized 1:1 to receive atezo (1200 mg intravenously every 3 weeks) or undergo observation as adjuvant treatment for up to 1 year. Pts will be stratified by number of lymph nodes resected, nodal status, tumor stage after cystectomy, age-adjusted Charlson Comorbidity Index and prior NAC. Inclusion criteria include histologically or cytologically confirmed MIBC, cystectomy with lymph node dissection and Eastern Cooperative Oncology Group performance status ≤ 2. Pts with prior NAC must have tumour staging of ypT2−T4a or ypN+; pts without prior NAC must be ineligible for or have declined cisplatin-based AC and have tumour staging of pT3−T4a or pN+. PD-L1 expression on IC in cystectomy tumour specimens will be centrally assessed using the SP142 immunohistochemistry (IHC) assay. Pts with a PD-L1 IHC score of IC2/3 (IC ≥ 5% PD-L1+) are eligible. The primary efficacy endpoint is disease-free survival. Secondary efficacy endpoints are overall survival, disease-specific survival and distant metastasis–free survival. The safety objective is to evaluate the safety and tolerability of atezo in the adjuvant setting. The exploratory objective is to assess predictive, prognostic and pharmacodynamic biomarkers. Disease recurrence will be determined by the investigator based on radiographic evidence with the support of available biopsy results. Approximately 440 pts will be enrolled globally. This trial is currently enrolling. For more information on this trial and other ongoing atezo clinical trials, please visit www.ClinicalTrials.gov. Bellmunt J.1, Powles T.2, Hussain M.3, Castellano D.4, Gschwend J.5, Culine S.6, Shen X.7, Nelson B.7, Fine G.7, Albers P.8 7th European Multidisciplinary Meeting on Urological Cancers 1Dana-Farber Cancer Institute, Bladder Cancer Center, Boston, 2Barts Cancer Institute, Queen Mary University of London, London, 3University of Michigan, Dept. of Medical Oncology, Ann Arbor, 4Hospital Universitario 12 De Octubre, Dept. of Oncology, Madrid, 5Technische Universität München, Dept. of Oncology, Munich, 6Hôpital Saint-Louis, Dept. of Oncology, Paris, 7Genentech, Inc., Genentech, Inc., South San Francisco, 8University of Düsseldorf, Dept. of Oncology, Düsseldorf 58565 EMUC15-0077 P099
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