Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

Summary

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

Timeline

Start

2016-06-30

Primary completion

2022-08-31

Completion

2024-02-12

Outcome

Mixed primary results

registry p = 0.0073; Hazard Ratio (HR) 0.82 (95% CI 0.70 to 0.96) NCT02807636 ↗

paper Progression-free survival benefit with first-line combination of atezolizumab plus platinum-based chemotherapy did not translate into a significant improvement in overall survival PMID 38101433 ↗

registry p = 0.3968; Hazard Ratio (HR) 0.98 (95% CI 0.82 to 1.16) NCT02807636 ↗

Publications

• Galsky MD, Guan X, Rishipathak D, Rapaport AS, Shehata HM, Banchereau R, Yuen K, Varfolomeev E, Hu R, Han CJ, Li H, Liang Y, Vucic D, Wang L, Zhu J, Yu H, Herbst RH, Hajaj E, Kiner E, Bamias A, De Santis M, Davis ID, Arranz JA, Kikuchi E, Bernhard S, Williams P, Lee C, Mellman I, Sanjabi S, Johnston R, Black PC, Grande E, Mariathasan S. Immunomodulatory effects and improved outcomes with cisplatin- versus carboplatin-based chemotherapy plus atezolizumab in urothelial cancer. Cell Rep Med. 2024 Feb 20;5(2):101393. doi: 10.1016/j.xcrm.2024.101393. Epub 2024 Jan 26.
• Grande E, Arranz JA, De Santis M, Bamias A, Kikuchi E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, O'Donnell PH, Kalebasty AR, Ye D, Mariathasan S, Bene-Tchaleu F, Bernhard S, Lee C, Davis ID, Galsky MD. Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):29-45. doi: 10.1016/S1470-2045(23)00540-5. Epub 2023 Dec 12.
• Bamias A, Davis ID, Galsky MD, Arranz JA, Kikuchi E, Grande E, Del Muro XG, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Schutz FA, Puente J, Li JR, Panni S, Gumus M, Ozguroglu M, Mariathasan S, Poloz Y, Bene-Tchaleu F, Lee C, Bernhard S, De Santis M. Atezolizumab monotherapy versus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis from a randomised, controlled, phase 3 study. Lancet Oncol. 2024 Jan;25(1):46-61. doi: 10.1016/S1470-2045(23)00539-9. Epub 2023 Dec 12.
• Grande E, Bamias A, Galsky MD, Kikuchi E, Davis ID, Arranz JA, Rezazadeh Kalebasty A, Garcia Del Muro X, Park SH, De Giorgi U, Alekseev B, Mencinger M, Izumi K, Puente J, Li JR, Bernhard S, Nicholas A, Telliez J, De Santis M. Overall Survival by Response to First-line Induction Treatment with Atezolizumab plus Platinum-based Chemotherapy or Placebo plus Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma. Eur Urol Open Sci. 2023 Nov 4;58:28-36. doi: 10.1016/j.euros.2023.10.002. eCollection 2023 Dec.
• Galsky MD, Arija JAA, Bamias A, Davis ID, De Santis M, Kikuchi E, Garcia-Del-Muro X, De Giorgi U, Mencinger M, Izumi K, Panni S, Gumus M, Ozguroglu M, Kalebasty AR, Park SH, Alekseev B, Schutz FA, Li JR, Ye D, Vogelzang NJ, Bernhard S, Tayama D, Mariathasan S, Mecke A, Thastrom A, Grande E; IMvigor130 Study Group. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020 May 16;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0.
• Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Carboplatin	Small molecule	4.5 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications