Data from A Phase II Trial of Guadecitabine plus Atezolizumab in Metastatic Urothelial Carcinoma Progressing after Initial Immune Checkpoint Inhibitor Therapy Article Swipe
H. Josh Jang
,
Galen Hostetter
,
Alexander W. MacFarlane
,
Zachary Madaj
,
Eric A. Ross
,
Toshinori Hinoue
,
Justin R. Kulchycki
,
Ryan S. Burgos
,
Mahvish Tafseer
,
R. Katherine Alpaugh
,
Candice L. Schwebel
,
Rutika Kokate
,
Daniel M. Geynisman
,
Matthew R. Zibelman
,
Pooja Ghatalia
,
Peter W. Nichols
,
Woonbok Chung
,
Jozef Madžo
,
Noah M. Hahn
,
David I. Quinn
,
Jean‐Pierre J. Issa
,
Michael J. Topper
,
Stephen B. Baylin
,
Hui Shen
,
Kerry S. Campbell
,
Peter A. Jones
,
Elizabeth R. Plimack
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.c.6571947.v3
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.c.6571947.v3
Purpose: Based on preclinical evidence of epigenetic contribution to sensitivity and resistance to immune checkpoint inhibitors (ICI), we hypothesized that guadecitabine (hypomethylating agent) and atezolizumab (anti-PD-L1) together would potentiate a clinical response in patients with metastatic urothelial carcinoma (UC) unresponsive to initial immune checkpoint blockade therapy. Patients and Methods:We designed a single arm Phase II study (NCT03179943) with a safety run-in to identify the recommended phase II dose of the combination therapy of guadecitabine and atezolizumab. Patients with recurrent/advanced urothelial carcinoma who had previously progressed on ICI therapy with PD-1 or PD-L1 targeting agents were eligible. Pre-planned correlative analysis was performed to characterize peripheral immune dynamics and global DNA methylation, transcriptome, and immune infiltration dynamics of patient tumors. Results: Safety run-in enrolled 6 patients and Phase II enrolled 15 patients before the trial was closed for futility. No dose-limiting toxicity was observed. Four patients, with best response of stable disease, exhibited extended tumor control (8-11 months) and survival (>14 months). Correlative analysis revealed lack of DNA demethylation in tumors after 2 cycles of treatment. Increased peripheral immune activation and immune infiltration in tumors after treatment correlated with progression-free survival and stable disease. Furthermore, high IL-6 and IL-8 levels in the patients’ plasma associates with short survival. Conclusions: No RECIST responses were observed after combination therapy in this trial. Although we could not detect the anticipated tumor-intrinsic effects of guadecitabine, the addition of hypomethylating agent to ICI therapy induced immune activation in a few patients, which associated with longer patient survival.
Related Topics
Concepts
Atezolizumab
Metastatic Urothelial Carcinoma
Oncology
Medicine
Cancer research
Internal medicine
Immunotherapy
Urothelial carcinoma
Bladder cancer
Cancer
Pembrolizumab
Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.1158/1078-0432.c.6571947.v3
- OA Status
- gold
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4402796787
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4402796787Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1158/1078-0432.c.6571947.v3Digital Object Identifier
- Title
-
Data from A Phase II Trial of Guadecitabine plus Atezolizumab in Metastatic Urothelial Carcinoma Progressing after Initial Immune Checkpoint Inhibitor TherapyWork title
- Type
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preprintOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
-
2024-09-16Full publication date if available
- Authors
-
H. Josh Jang, Galen Hostetter, Alexander W. MacFarlane, Zachary Madaj, Eric A. Ross, Toshinori Hinoue, Justin R. Kulchycki, Ryan S. Burgos, Mahvish Tafseer, R. Katherine Alpaugh, Candice L. Schwebel, Rutika Kokate, Daniel M. Geynisman, Matthew R. Zibelman, Pooja Ghatalia, Peter W. Nichols, Woonbok Chung, Jozef Madžo, Noah M. Hahn, David I. Quinn, Jean‐Pierre J. Issa, Michael J. Topper, Stephen B. Baylin, Hui Shen, Kerry S. Campbell, Peter A. Jones, Elizabeth R. PlimackList of authors in order
- Landing page
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https://doi.org/10.1158/1078-0432.c.6571947.v3Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1158/1078-0432.c.6571947.v3Direct OA link when available
- Concepts
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Atezolizumab, Metastatic Urothelial Carcinoma, Oncology, Medicine, Cancer research, Internal medicine, Immunotherapy, Urothelial carcinoma, Bladder cancer, Cancer, PembrolizumabTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- Related works (count)
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10Other works algorithmically related by OpenAlex
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