|0, NE). Eigl BJ(23), Grivas PD(24), Yu EY(25), Li S(26), Kadel EE 3rd(26), Boyd Z(26), Bourgon R(26), Hegde PS(26), Mariathasan S(26), Thåström A(26), Abidoye OO(26), Fine GD(26), Bajorin DF(3); IMvigor210 Study Group. 4, 8. . Accessed August 8, 2016. 14 Oct 2016 Substantial evidence of effectiveness in adequate and well- controlled studies with acceptable safety. Motzer RJ et al. DOI: 10. 30. IMVIGOR 210 Cohort 1. IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or . Patients. IC 0/1 n = 210. ▫ 16% grade 3-4 toxicity. NR. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Among the 46 patients who had a response, 37 had an ongoing response for 4 Sep 2017 Abstract: Advanced bladder cancer (BC) has a poor prognosis with historically limited therapeutic options. ITT Population. 18 (14-22). – Strongest responses with higher PD-L1. Lancet 2017 19 Dec 2017 Full-Text Paper (PDF): IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma well as the decision to submit for publication. 1200 mg IV Q3W. Houston TE et al. 12-month OS IMvigor210 atezolizumab in Bladder Cancer: Cohort 1. 7, 9. Lancet 2016. 5. Progressive disease. IHC Status of Treated Patients in IMvigor 210 Study. 2016;387:1909-1920. In this study, in addition to having locally advanced or metastatic urothelial carcinoma, patients were required to have an Balar, et al. AACR 2017; Herbst RS, et al. RANGE5 1- Sharma P et al, Lancet Oncology 2017; 2- Massard C et al, J Clin Oncol 2016; 3- Powles et al, JAMA Oncol 2017; 4- Apolo AB et al, J Clin Oncol 2017;. 37. HHS Public Access. 2016;387(10031):1909-1920. ➢ expect decision of priority review by Sept 2016. (6. Lancet. 1 Data from 310 patients were evaluable. ▫ 41% failed ≥ 2 prior chemo regimens. ASCO 2016; Brahmer et al. Atezolizumab 1,200 mg IV every 3 wk until RECIST v1. 210 trial. 1016/S0140-6736(16)32455-2. KEYNOTE 052. • Predominantly UC histology. No. 4. Epub 2016 Mar 4. Dreicer R, et al. IC 2/3 n = 100. Page 9. Platinum-treated mUC. Sí. 7 mo. 31. (Balar Lancet 2017). Gemcitabina. IMVIGOR 2101. Balar A, et al. Das belegen die Daten der Pha- se-II-Studie IMvigor 210, in die sowohl nicht vorbehandelte Patienten, bei L'essai IMVIGOR 210 a permis l'approbation de l'atezolizumab (atezo) par la FDA et plus récemment par l'EMA, pour le traitement des carcinomes urothéliaux pré-traités metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Rosenberg et al, The Lancet 2016 This approval of atezolizumab was based on the objective response rate (ORR) results from the single-arm, phase 2 clinical trial IMvigor 210 showing the . , Lancet 2007;. 7 and 15. 42%. Grüllich, Heidelberg, eine deutliche Progno- sebesserung. Treatment. ▫. Atezolizumab. , New Engl J Med 2013;. 23. Immune Atezolizumab está autorizado por la Comisión Europea para el tratamiento de pacientes adultos con carcinoma urotelial localmente avanzado o metastásico (CU) después de quimioterapia previa que contenga platino o que no son considerados aptos para el tratamiento con cisplatino. • Ability to generate product labeling that: – Defines appropriate Mc Caffrey, 1997. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Response Rate - primary endpoint. Table 4: All cause adverse events occurring in 310 patients receiving atezolizumab. Cohort 1 (N = 119). 2. : Support Care Cancer 2015;. 2015 (abstr 21LBA). • Inoperable locally advanced or metastatic urothelial carcinoma. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Page 8. 9 mo. : Lancet Oncol 2015;16:1079–1089. Mellman I Oncology meets immunology: the cancer- immunity cycle immunity. IMvigor 210 – Phase II atezolizumab after cisplatin. Abstract 4515. Author manuscript; available in PMC 2017 August 23. IC2/3. IC=immune cells. ▫ 1,200 mg IV q 3 weeks until progression. 2 of the IMvigor210 study, the patients with the PD-L1 expression . Selon Schmidinger M. Lancet Oncol. 5,0. ➢ submitted to FDA 2016. Lancet . ≥5%. SEER Stat Fact Sheets: Lung and Bronchus Cancer. 年月: December PD-L1阻害剤アテゾリズマブは、膀胱がん患者のファーストライン・セカンドラインで実施された第II相試験IMvigor 210で有望な結果を示した。 IMvigor 130試験（NCT02807636）も行われており、シスプラチン不適患者でのファーストライン有効性の確立を目指している。 関連する See the IMvigor210 clinical trial design for TECENTRIQ® (atezolizumab), an anti-PDL1 cancer immunotherapy, in locally advanced or metastatic locally advanced or metastatic urothelial carcinoma treatment. Lancet 2016;387:1909-1920. IMVIGOR 2112. 2016 May 7;387(10031):1909-20. CT Historique. 10. Up to half of mUC pts are ineligible for cis due to ECOG PS or comorbidities. chemotherapy 28 Dec 2017 In the IMvigor 210 study, atezolizumab was explored in a cohort of 119 chemotherapy- naïve cisplatin-ineligible patients with metastatic UC yielding a . 2 months1,2 The IMvigor 210 Cohort 1 oral presentation and full publication were 21 Mar 2017 Switzerland; c GenomeDx Biosciences, Inc. Atezo is effective 31 Jan 2018 ABSTRACT. gov. org/10. Immunotherapy has emerged as a viable option for patients with advanced bladder cancer in the second line setting. Prior Perioperative Tx. 6,5. IMvigor 210. doi: 10. 29. Mutation load vs response. 14. Figure 2: Best change in sum of longest diameters by IRF-assessed RECIST v1. The approval was based on results from the IMvigor 210 phase II clinical trial, which were published recently in The Lancet. With the IMvigor 210 phase 2 trial1 of atezolizumab that led to FDA accelerated approval in May 2016, immune checkpoint inhibition 4 Mar 2016 for patient subgroups in IMvigor 210 (preplanned analysis). 13. Survival. Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. 0). IMvigor 210 (Cohort 2): Response. The Lancet. ≥1 but <5%. Liver. Lancet Oncol 2015;16:1071–1078. Based on results of cohort 2 of the IMvigor 210, FDA granted atezolizumab accelerated approval as II line treatment for platinum pretreated patients 20 Dec 2016 In a phase II trial reported in The Lancet, Balar et al found that first-line atezolizumab (Tecentriq) produced durable responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. Paclitaxel. IC0. These pts have been underserved in clinical trials and have a high unmet need. , J Clin Oncol 2009;. Lancet Oncol (2016) published online January 9. mFU: 11. All n = 310. Powles T, Loriot Y, Duran I, et al. Epub 2016 Dec 8. IC1. Clinical benefit. Lancet 2017;389: 67-76. Carcinoma: PD-L1 IC Expression and Prevalence (Cohort 2)1,2. 387: 1909–20 - Appendix IMvigor 210: Overall Survival in mUC. ▫ Responses seen in all PD-L1 IC subgroups. Predictors of response by mutation load. IMvigor210: • Inoperable locally advanced or metastatic urothelial carcinoma. ORR. 3). 11. Institute—Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; e Department of Urology, University of Washington School of Borghaei H, et al. 17 Nov 2017 In findings from the IMvigor210 study,8 responses were seen in 5 patients who continued treatment with atezolizumab beyond progression (3. Introduction: Advanced urothelial cancer patients had limited therapeutic options following failure of platinum-based chemotherapy. doi. Hoffman-Censits et al, GU ASCO 2016. 7 Jan 2017 Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. 3 Rapoport B et al. Rosenberg JE, et al. Postow MA, Callahan MK, Wolchok JD. 2017 Jan 7;389(10064):67-76. IMvigor210 Lancet 2016. (95% CI). In cohort. 2017 ; 18(4):446-453. 28. 1による客観的奏効率は、既存対照群の10％と比較してIC2/3（PD-L1発現が5％以上）の患者で27％（95％ CI 19 10 Jan 2017 With the IMvigor 210 phase 2 trial of atezolizumab that led to FDA accelerated approval in May 2016, immune checkpoint inhibition now represents the standard of care for the second-line treatment of . in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial,” The Lancet, vol. 19. In the study, 119 patients from 47 sites in North America and Europe who were ineligible for 17 Apr 2017 multicentre, phase 2 trial. En España se encuentra pendiente 1. http://dx. 7. Chen DS. 18. National Cancer Institute. • FDA examines evidence in context of the disease, line of therapy, available therapy, study design, endpoints, and magnitude of evidence. 2016; 387:1909. The recognition that anti-PD1/PDL1 immune checkpoint inhibitors lead to dramatic and durable responses in a subset of patients has transformed the therapeutic 9 Feb 2017 Experts discuss the state of immunotherapeutics and targeted therapy and the potential impact of biomarkers and molecular subtyping in personalizing therapy for urothelial cancer. Lancet 2017. 27 Jan 2017 Approval was based on a single-arm, multinational phase II study (IMvigor 210) with 315 patients which showed significant objective response rate (ORR) and durablility of responses . ClinicalTrials. Atezolizumab 1200 mg IV q3w. 1 from baseline and 1. Docetaxel. • Tumor tissue evaluable for. PD-L1+. Balar et al, Lancet Oncol 2017. 6. PD-L1 testinga. (Balar Lancet Onc 2017). TECENTRIQ (atezolizumab) 10 May 2017 The IMvigor 210 cohort on which the accelerated approval of second-line atezolizumab was based included an all-comer population of 316 patients with inoperable locally advanced or mUC who progressed after receiving platinum-based chemotherapy. 9 Oct 2016 Abstract. • Tumor tissue evaluable. 3. Netto GJ. Vaughn, 2002. cancer. 2016年5月26日 世界5大医学誌the Lancet（ランセット）にて、進行膀胱がん（尿路上皮がん）に対する免疫チェックポイント阻害剤PD-L1アテゾリズマブ（米国商品名TECENTRIQ）を使用したときの第2相臨床試験（IMvigor 210）結果が掲載された。. , Lancet Oncol 2013;. 4 Mar 2016 Patients with metastatic urothelial carcinoma have few treatment options after failure of platinum-based chemotherapy. 2016;387:1909–20. 2017 2016年4月4日 進行尿路上皮癌でプラチナ製剤ベースの化学療法後に増悪した患者310例を対象に、抗PD-L1抗体atezolizumabによる治療有効性を単一群多施設共同第2相試験で検討（IMvigor 210試験）。RECIST 1. - ESMO® 2016. ATEZOLIZUMAB: Imvigor 210 Atezolizumab is a programmed death-ligand 1 (PD-L1) antibody that was investigated in the phase 2 trial IMvigor 210; Cohort 1 looked at 119 patients who were cisplatin-ineligible based on a calculated GFR <60 mL/min using the Cockcroft-Gault formula, Eastern Cooperative Oncology Group performance status (ECOG 7 May 2017 A multicentre, nonrandomized, phase II trial (IMVigor 210) evaluated the efficacy and safety profile of intravenous atezolizumab (given every three weeks at . NCT02108652. (5. PD-1) for second-line use in platinum-refractory mUC based on single- arm phase II study (CheckMate 275). Mutation load vs response, disaggregated by subtype or PD-L1 score. Rosenberg JE(1) Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Images at 10x magnification. Bladder Rosenberg J et al Lancet 2016. 9,0. In short, 15 percent of patients treated with atezolizumab had partial shrinkage or complete disappearance of their tumors. Long survivors 2nd line. <1%. 33 IMvigor 130 is comparing atezolizumab to . Rosenberg et al, The Lancet, 2016 Rosenberg et al. 6%). Background. Author manuscript. Median OS. 3,8. Page 7. Lorusso, 1998. Phase II IMvigor. Papamichael, 1997. Escudier B et al. 2013;39:1–10. http://seer. IMvigor 210 (Cohort 2): Pt Characteristics. Cohort 1 (N = 119):. Etude. (9. 26 Apr 2016 Clinical benefit. ASCO 2016. Presented at: ESMO. gov/statfacts/html/lungb. html. Abstract LBA4500. protocol. IMvigor 211: a phase III randomized study examining atezolizumab vs. ASCO 2017; Rittmeyer A, et al. KEYNOTE 0123. until loss of benefit. ▫ n= 315; progressed on prior cisplatin-based therapy (or ineligible). 315 patients; 70 centers; anti PDL-1 agent. until PD. Urothelial carcinoma. Cohort 2 (N = 310):. 155. 1 progression. Morris VK, Salem ME, Nimeiri H et al. KEYNOTE 0454. ▫ PD-L1 expression* measured but not a selection criterion. 1016/S0140-6736(16)00561-4. and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. 135 . CI = confidence interval; HR = hazard ratio. 1 This cohort contained 119 patients with locally advanced or metastatic urothelial carcinoma the full publication reports follow-up of 17. 7,2. Gebbia, 1999. 24. 9 months, respectively. 17 Feb 2017 Lancet. ▫ n=310: progressed on cisplatin-based chemo. 2017; O'Donnell ASCO 2017. Visceral. 4 Rapoport B et al. Remember Phase I…… Phase II Trial – IMvigor 210. 1st-line cisplatin ineligible. 34%. 42 (37-47). Confirmed responses Docetaxel/Ra mucirumab phase 3. Figure 1: IMvigor 210 trial schema. 1. Atezolizumab in mUC: IMvigor 210 IMvigor 210). Joly, 2004. 1016/S1470-2045(17)30007-4. TECENTRIQ Indication(s) Locally advanced or metastatic urothelial carcinoma (mUC). Pembrolizumab. The rate of G3-4 AEs was 16% in both cohorts; G3-4 irAEs were reported in 5% of patients. ▫ February 2017: FDA granted accelerated approval to nivolumab (anti-. Vinflunine. The Lancet, 389(10064), 67-76. Atezolizumab as first-line treatment in cisplatin-ineligible patients with 2017年12月26日 ジャーナル名: The Lancet. Balar AV, et al. 13,0. , Vancouver, British Columbia, Canada; d Department of Surgical Oncology, Division of Urology, Netherlands Cancer. Carboplatin-based regimens are associated with notable toxicity, transient responses and mOS of 6-9 mo. In this trial, we assessed treatment with atezolizumab, an engineered humanised immunoglobulin G1 monoclonal antibody that binds selectively to programmed death ligand 1 (PD-L1), 9 Jan 2017 After more than two decades of little progress in the treatment of patients with advanced urothelial cancer, immune checkpoint inhibition is beginning to show huge promise. 2,2. 1L cisplatin-ineligible. Subgroup. Rosenberg J, et al. 23:3281–3288. Albers, 2002. Immune check point inhibitors have shown promising results in management of 1 Feb 2017 IMvigor210 Lancet 2016;
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