Journal article
Efficacy of enfortumab vedotin in advanced urothelial cancer: Analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study
Cancer, Vol.128(6), pp.1194-1205
03/15/2022
DOI: 10.1002/cncr.34057
PMID: 34882781
Abstract
Enfortumab vedotin (EV) is a novel antibody-drug conjugate approved for advanced urothelial cancer (aUC) refractory to prior therapy. In the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study, the authors looked at the experience with EV in patient subsets of interest for which activity had not been well defined in clinical trials.
UNITE was a retrospective study of patients with aUC treated with recently approved agents. This initial analysis focused on patients treated with EV. Patient data were abstracted from chart reviews by investigators at each site. The observed response rate (ORR) was investigator-assessed for patients with at least 1 post-baseline scan or clear evidence of clinical progression. ORRs were compared across subsets of interest for patients treated with EV monotherapy.
The initial UNITE analysis included 304 patients from 16 institutions; 260 of these patients were treated with EV monotherapy and included in the analyses. In the monotherapy cohort, the ORR was 52%, and it was >40% in all reported subsets of interest, including patients with comorbidities previously excluded from clinical trials (baseline renal impairment, diabetes, and neuropathy) and patients with fibroblast growth factor receptor 3 (FGFR3) alterations. Progression-free survival and overall survival were 6.8 and 14.4 months, respectively. Patients with a pure urothelial histology had a higher ORR than patients with a variant histology component (58% vs 42%; P = .06).
In a large retrospective cohort, responses to EV monotherapy were consistent with data previously reported in clinical trials and were also observed in various patient subsets, including patients with variant histology, patients with FGFR3 alterations, and patients previously excluded from clinical trials with an estimated glomerular filtration rate < 30 mL/min and significant comorbidities.
Enfortumab vedotin, approved by the Food and Drug Administration in 2019, is an important new drug for the treatment of patients with advanced bladder cancer. This study looks at the effectiveness of enfortumab vedotin as it has been used at multiple centers since approval, and focuses on important patient populations previously excluded from clinical trials. These populations include patients with decreased kidney function, diabetes, and important mutations. Enfortumab vedotin is effective for treating these patients. Previously reported clinical trial data have been replicated in this real-world setting, and support the use of this drug in broader patient populations.
Details
- Title: Subtitle
- Efficacy of enfortumab vedotin in advanced urothelial cancer: Analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study
- Creators
- Vadim S Koshkin - UCSF Helen Diller Family Comprehensive Cancer CenterNicholas Henderson - Michigan Center for Translational PathologyMarihella James - The University of Texas MD Anderson Cancer CenterDivya Natesan - UCSF Helen Diller Family Comprehensive Cancer CenterDory Freeman - Dana-Farber Cancer InstituteAmanda Nizam - Cleveland ClinicChristopher T Su - Michigan Center for Translational PathologyAli Raza Khaki - University of WashingtonChelsea K Osterman - University of North Carolina at Chapel HillMichael J Glover - Stanford UniversityRyan Chiang - Stanford UniversityDimitrios Makrakis - Seattle Cancer Care AllianceRafee Talukder - Seattle Cancer Care AllianceEmily Lemke - Medical College of WisconsinT Anders Olsen - Emory UniversityJayanshu Jain - University of IowaAlbert Jang - Tulane UniversityAlicia Ali - Michigan Center for Translational PathologyTanya Jindal - UCSF Helen Diller Family Comprehensive Cancer CenterJonathan Chou - UCSF Helen Diller Family Comprehensive Cancer CenterTerence W Friedlander - UCSF Helen Diller Family Comprehensive Cancer CenterChristopher Hoimes - Duke UniversityArnab Basu - University of Alabama at BirminghamYousef Zakharia - University of IowaPedro C Barata - Tulane UniversityMehmet A Bilen - Emory UniversityHamid Emamekhoo - University of Wisconsin–MadisonNancy B Davis - Vanderbilt UniversitySumit A Shah - Stanford UniversityMatthew I Milowsky - University of North Carolina at Chapel HillShilpa Gupta - Cleveland ClinicMatthew T Campbell - The University of Texas MD Anderson Cancer CenterPetros Grivas - University of WashingtonGuru P Sonpavde - Dana-Farber Cancer InstituteDeepak Kilari - Medical College of WisconsinAjjai S Alva - Michigan Center for Translational Pathology
- Resource Type
- Journal article
- Publication Details
- Cancer, Vol.128(6), pp.1194-1205
- DOI
- 10.1002/cncr.34057
- PMID
- 34882781
- NLM abbreviation
- Cancer
- ISSN
- 0008-543X
- eISSN
- 1097-0142
- Grant note
- P30 CA016672 / NIH HHS
- Language
- English
- Date published
- 03/15/2022
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984544951702771
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