Atezolizumab monotherapy for metastatic urothelial carcinoma: final analysis from the phase II IMvigor210 trial

被引：1

作者：

Rosenberg, J. E. ^{[1
]}

Galsky, M. D. ^{[2
]}

Powles, T. ^{[3
]}

Petrylak, D. P. ^{[4
]}

Bellmunt, J. ^{[5
]}

Loriot, Y. ^{[6
]}

Necchi, A. ^{[7
,8
]}

Hoffman-Censits, J. ^{[9
]}

Perez-Gracia, J. L. ^{[10
]}

van der Heijden, M. S. ^{[11
]}

Dreicer, R. ^{[12
]}

Duran, I. ^{[13
,24
]}

Castellano, D. ^{[14
]}

Drakaki, A. ^{[15
]}

Retz, M. ^{[16
]}

Sridhar, S. S. ^{[17
]}

Grivas, P. ^{[18
,19
,20
]}

Yu, E. Y. ^{[19
,20
]}

O'Donnell, H. ^{[21
]}

Burris, H. A. ^{[22
]}

Mariathasan, S. ^{[23
]}

Shi, Y. ^{[23
]}

Goluboff, E. ^{[23
]}

Bajorin, D. ^{[1
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10065 USA

[2] Icahn Sch Med Mt Sinai, Tisch Canc Inst, New York, NY 10029 USA

[3] Queen Mary Univ London ECMC, Barts Canc Inst, Barts Hlth, London, England

[4] Yale Canc Ctr, New Haven, CT USA

[5] Harvard Med Sch, Dana Farber Canc Inst, PSMAR IMIM Lab, Boston, MA USA

[6] Univ Paris Sud, Univ Paris Saclay, Gustave Roussy, Villejuif, France

[7] Univ Vita Salute San Raffaele, Milan, Italy

[8] IRCCS San Raffaele Hosp, Milan, Italy

[9] Johns Hopkins, Baltimore, MD USA

[10] Clin Univ Navarra, Dept Oncol, Pamplona, Spain

[11] Netherlands Canc Inst, Amsterdam, Netherlands

[12] Univ Virginia, Canc Ctr, Charlottesville, VA USA

[13] Hosp Univ Virgen del Rocio, Seville, Spain

[14] Hosp 12 Octubre, Madrid, Spain

[15] Univ Calif Los Angeles, Los Angeles, CA USA

[16] Tech Univ Munich, Munich, Germany

[17] Princess Margaret Canc Ctr, Dept Med Oncol & Hematol, Toronto, ON, Canada

[18] Cleveland Clin, Taussig Canc Inst, Cleveland, OH USA

[19] Univ Washington, Seattle, WA USA

[20] Fred Hutchinson Canc Ctr, Seattle, WA USA

[21] Univ Chicago, Chicago, IL USA

[22] Sarah Cannon Res Inst, Nashville, TN USA

[23] Genentech Inc, South San Francisco, CA USA

[24] Hosp Univ Marques Valdecilla, IDIVAL, Santander, Spain

来源：

ESMO OPEN | 2024年 / 9卷 / 12期

关键词：

metastatic urothelial carcinoma; checkpoint inhibitor; long-term survival; PD-L1-high; cisplatin-ineligible; platinum-refractory; PEMBROLIZUMAB; MULTICENTER;

D O I：

10.1016/j.esmoop.2024.103972

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The IMvigor210 trial demonstrated clinical benefit and manageable toxicity with atezolizumab monotherapy [anti-programmed death-ligand 1 (PD-L1)] in patients with metastatic urothelial carcinoma (UC) in primary analyses. Final efficacy and safety results after long-term follow-up are reported. Patients and methods: This phase II single-arm trial of atezolizumab monotherapy in patients with advanced UC included two cohorts: untreated patients ineligible for cisplatin-based chemotherapy (cohort 1; n = 119) and those previously treated with platinum-based chemotherapy (cohort 2; n = 310). Atezolizumab was administered i.v. (1200 mg every 21 days) until progression or unacceptable toxicity. Primary endpoints were independent review facility-assessed confirmed objective response rate (ORR) per RECIST 1.1 in cohort 1 and independent review facility-assessed ORR per RECIST 1.1 and investigator-assessed modified (m)RECIST in cohort 2. Overall survival (OS), efficacy by PD-L1 status, and safety were also assessed. Results: At data cut-off (1 June 2023), the median survival follow-up was 96.4 months (range, 0.2-103.4 months) in cohort 1 and 46.2 months [0.2 (censored)-54.9 months] in cohort 2. In cohort 1, the ORR [95% confidence interval (CI)] was 23.5% (16.2% to 32.2%) in all patients and 28.1% (13.8% to 46.8%) in the PD-L1 tumor-infiltrating immune cell (IC)2/3 subgroup. Median OS (95% CI) was 16.3 months (10.4-24.5 months) overall and 12.3 months (6.0-49.8 months) in the PD-L1 IC2/3 subgroup. In cohort 2, the ORR (95% CI) was 16.5% (12.5% to 21.1%) per RECIST 1.1 and 19.7% (95% CI 15.4% to 24.6%) per mRECIST in all patients and 27.0% (18.6% to 36.8%) and 28.0% (19.5% to 37.9%), respectively, in the PD-L1 IC2/3 subgroup. Median OS (95% CI) was 7.9 months (6.7-9.3 months) in all patients and 11.9 months (9.0-22.8 months) in the IC2/3 subgroup. Treatment-related grade 3/4 adverse events occurred in 21.8% (cohort 1) and 18.7% (cohort 2); one treatment-related death occurred in cohort 1. Conclusions: With long-term follow-up, atezolizumab monotherapy demonstrated clinically meaningful efficacy with durable in a subset of with metastatic UC; there were no new

引用

页数：10

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