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Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma)

Authors
 Alexandra Drakaki  ;  Thomas Powles  ;  Aristotelis Bamias  ;  Juan Martin-Liberal  ;  Sang Joon Shin  ;  Terence Friedlander  ;  Diego Tosi  ;  Chandler Park  ;  Carlos Gomez-Roca  ;  Florence Joly Lobbedez  ;  Daniel Castellano  ;  Rafael Morales-Barrera  ;  Irene Moreno-Candilejo  ;  Aude Fléchon  ;  Kobe Yuen  ;  Deepali Rishipathak  ;  Kelly DuPree  ;  Fiona Young  ;  Francesca Michielin  ;  Colby S Shemesh  ;  Elizabeth E Steinberg  ;  Patrick Williams  ;  Jae Lyun Lee 
Citation
 CLINICAL CANCER RESEARCH, Vol.29(21) : 4373-4384, 2023-11 
Journal Title
CLINICAL CANCER RESEARCH
ISSN
 1078-0432 
Issue Date
2023-11
MeSH
Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Carcinoma, Transitional Cell* / pathology ; Humans ; Platinum / therapeutic use ; Urinary Bladder Neoplasms* ; Urologic Neoplasms* / pathology
Abstract
Purpose: The MORPHEUS platform was designed to identify early efficacy signals and evaluate the safety of novel immunotherapy combinations across cancer types. The phase Ib/II MORPHEUS-UC trial (NCT03869190) is evaluating atezolizumab plus magrolimab, niraparib, or tocilizumab in platinum-refractory locally advanced or metastatic urothelial carcinoma (mUC). Additional treatment combinations were evaluated and will be reported separately.

Patients and methods: Patients had locally advanced or mUC that progressed during or following treatment with a platinum-containing regimen. The primary efficacy endpoint was investigator-assessed objective response rate (ORR). Key secondary endpoints included investigator-assessed progression-free survival (PFS) and overall survival (OS). Safety and exploratory biomarker analyses were also conducted.

Results: Seventy-six patients were randomized to receive either atezolizumab plus magrolimab (n = 16), atezolizumab plus niraparib (n = 15), atezolizumab plus tocilizumab (n = 15), or atezolizumab monotherapy (control; n = 30). No additive benefit in ORR, PFS, or OS was seen in the treatment arms versus the control. The best confirmed ORR was 26.7% with atezolizumab plus magrolimab, 6.7% with atezolizumab plus niraparib, 20.0% with atezolizumab plus tocilizumab, and 27.6% with atezolizumab monotherapy. Overall, the treatment combinations were tolerable, and adverse events were consistent with each agent's known safety profile. Trends were observed for shrinkage of programmed death-ligand 1-positive tumors (atezolizumab, atezolizumab plus magrolimab, atezolizumab plus tocilizumab), inflamed tumors, or tumors with high mutational burden (atezolizumab), and immune excluded tumors (atezolizumab plus magrolimab).

Conclusions: The evaluated regimens in MORPHEUS-UC were tolerable. However, response rates for the combinations did not meet the criteria for further development in platinum-experienced locally advanced or mUC.
Full Text
https://aacrjournals.org/clincancerres/article/29/21/4373/729622/Atezolizumab-plus-Magrolimab-Niraparib-or
DOI
10.1158/1078-0432.CCR-23-0798
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Shin, Sang Joon(신상준) ORCID logo https://orcid.org/0000-0001-5350-7241
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/197278
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