Abstract
What is this summary about?
This summary provides the results of a study of two treatments for cancer, enfortumab vedotin and pembrolizumab, that were studied together against locally advanced or metastatic urothelial cancer (la/mUC), a cancer that occurs most commonly in the bladder.
What were the results?
In the 45 patients studied, around 16% did have serious side effects, but most side effects were manageable. Twenty-four percent of patients, however, stopped the study treatment because of their side effects.
Within about 2 months of starting treatment, most patients' (73%) tumors were smaller and stayed smaller, on average, for more than 2 years.
What do the results mean?
The combination of enfortumab vedotin plus pembrolizumab is a new treatment option for patients with locally advanced or metastatic urothelial cancer when they cannot receive the typical treatment, cisplatin. Advanced or metastatic urothelial cancer is a type of cancer where the cancer has already spread outside of the bladder or urinary tract.
Keywords: enfortumab vedotin, lay summary, pembrolizumab, plain language summary, urothelial cancer
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Acknowledgments
The authors thank everyone who took part in the study.
Footnotes
Financial & competing interests disclosure
Christopher J Hoimes: Honoraria: Seagen Inc.; Consulting or Advisory Role: Bristol Myers Squibb, Eisai, Prometheus, Seagen Inc., Genentech/Roche, Merck Sharp & Dohme, 2bPrecise; Speakers' Bureau: Bristol Myers Squibb, Genentech/Roche, Astellas Pharma, Seagen Inc., Eisai; Research Funding: Merck Sharp & Dohme (Institution), Janssen Oncology (Institution), Novartis (Institution), Alkermes (Institution), Seagen Inc. (Institution), Astellas Pharma (Institution), Bristol Myers Squibb Foundation (Institution), BioNTech SE (Institution), Crispr Therapeutics (Institution), NeoImmune Tech (Institution), Mirati Therapeutics (Institution); Uncompensated Relationships: 2bPrecise (Institution). Thomas W Flaig: Leadership: Aurora Oncology; Stock and Other Ownership Interests: Aurora Oncology; Consulting or Advisory Role: Seagen Inc., Janssen Oncology; Research Funding: Novartis, Bavarian Nordic, Dendreon, GTx, Janssen Oncology, Medivation, Sanofi, Pfizer, Bristol Myers Squibb, Roche/Genentech, Exelixis, Aragon Pharmaceuticals, Sotio, Tokai Pharmaceuticals, AstraZeneca/MedImmune, Lilly, Astellas Pharma, Agensys, Seagen Inc., La Roche-Posay, Merck; Patents, Royalties, Other Intellectual Property: The University of Colorado has filed two patents related in which I am an inventor. These are related to early-stage bladder cancer treatment and detection. Neither is commercialized or licensed at this time. Matthew I Milowsky: Stock and Other Ownership Interests: Pfizer, Merck, Gilead Sciences; Consulting or Advisory Role: Loxo/Lilly; Research Funding: Merck (Institution), Roche/Genentech (Institution), Bristol Myers Squibb (Institution), Mirati Therapeutics (Institution), Incyte (Institution), Seagen Inc. (Institution), G1 Therapeutics (Institution), Alliance Foundation Trials (Institution), Alliance for Clinical Trials in Oncology (Institution), Clovis Oncology (Institution), Arvinas (Institution), Regeneron (Institution); Other Relationship: Elsevier, Medscape. Terence W Friedlander: Leadership: Med BioGene; Honoraria: EMD Serono, AstraZeneca/MedImmune, Astellas Scientific and Medical Affairs Inc.; Consulting or Advisory Role: AbbVie, Dendreon, Dava Oncology; EMD Serono, Merck, Astellas Pharma, Foundation Medicine, Basilea; Research Funding: Janssen, Seagen Inc. (Institution), Incyte (Institution), Bristol Myers Squibb (Institution), Neon Therapeutics (Institution), Roche/Genentech (Institution); Travel, Accommodations, Expenses: AstraZeneca/MedImmune, Genentech/Roche, Jounce Therapeutics. Mehmet Asim Bilen: Consulting or Advisory Role: Exelixis, Sanofi, Nektar, EMD Serono, Eisai, Janssen, Genomic Health, Pfizer, Bristol Myers Squibb, Bayer, Calithera Biosciences, AstraZeneca, Seagen Inc.; Research Funding: Bayer (Institution), Bristol Myers Squibb (Institution), Genentech/Roche (Institution), Incyte (Institution), Nektar (Institution), AstraZeneca (Institution), Tricon Pharmaceuticals (Institution), Pfizer (Institution), Seagen Inc. (Institution), Xencor (Institution), Exelixis (Institution), Advanced Accelerator Applications (Institution), Genome & Company (Institution), Peloton Therapeutics (Institution), Merck (Institution), NiKang Therapeutics (Institution). Shilpa Gupta: Stock and Other Ownership Interests: Nektar, Moderna Therapeutics; Honoraria: Bristol Myers Squibb; Consulting or Advisory Role: Gilead Sciences, Guardant Health, AVEO, EMD Serono, Pfizer, Merck, Loxo/Lilly; Speakers' Bureau: Bristol Myers Squibb, Janssen Oncology. Sandy Srinivas: Consulting or Advisory Role: Eisai, Bayer, Bristol Myers Squibb, Merck, AstraZeneca, Seagen Inc., Janssen Oncology, Novartis; Research Funding: Bristol Myers Squibb (Institution), Genentech (Institution), Merck (Institution), Exelixis (Institution), Eisai (Institution), Bayer (Institution), AstraZeneca (Institution), Seagen Inc./Astellas (Institution); Other Relationship: Pfizer. Jaime R Merchan: Consulting or Advisory Role: Merck; Research Funding: Corvus Pharmaceuticals (Institution), Genentech/Roche (Institution), Tizona Therapeutics Inc. (Institution), Tocagen (Institution), Vyriad (Institution), Sillagen (Institution), Replimune (Institution), Peloton Therapeutics (Institution), Eisai (Institution), Seagen Inc./Astellas (Institution), Merck (Institution), Rubius Therapeutics (Institution), BioNTech (Institution), Trishula Therapeutics (Institution), Exelixis (Institution); Patents, Royalties, Other Intellectual Property: UpToDate. Rana R McKay: Consulting or Advisory Role: Janssen, Novartis, Tempus, Exelixis, Pfizer, Bristol Myers Squibb, Astellas Medivation, Dendreon, Bayer, Sanofi, Merck, Vividion Therapeutics, Calithera Biosciences, AstraZeneca, Myovant Sciences, Caris Life Sciences, Sorrento Therapeutics, AVEO; Research Funding: Pfizer (Institution), Bayer (Institution), Tempus (Institution). Daniel P Petrylak: Stock and Other Ownership Interests: Bellicum Pharmaceuticals, TYME; Consulting or Advisory Role: Bayer, Exelixis, Pfizer, Roche, Astellas Pharma, AstraZeneca, Lilly, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Incyte, Janssen, Pharmacyclics, Seagen Inc., UroGen Pharma, Advanced Accelerator Applications, Ipsen, Bicycle Therapeutics, Mirati Therapeutics, Monopteros Therapeutics, Regeneron, Gilead Sciences; Research Funding: Progenics (Institution), Sanofi (Institution), Endocyte (Institution), Genentech (Institution), Merck (Institution), Astellas Medication (Institution), Novartis (Institution), AstraZeneca (Institution), Bayer (Institution), Lilly (Institution), Innocrin Pharma (Institution), MedImmune (Institution), Pfizer (Institution), Roche (Institution), Seagen Inc., Clovis Oncology (Institution), Bristol Myers Squibb (Institution), Advanced Accelerator Applications (Institution), Agensys (Institution), BioXcel Therapeutics (Institution), Eisai (Institution), Mirati Therapeutics (Institution), Replimune (Institution), Medivation (Institution), Gilead Sciences (Institution); Expert Testimony: Celgene, Sanofi. Carolyn Sasse: Employment: Astellas Pharma. Blanca Homet Moreno: Employment: Merck Sharp & Dohme; Stock and Other Ownership Interests: Merck Sharp & Dohme. Yao Yu: Employment (former): Seagen Inc.; Stock and Other Ownership Interests: Seagen Inc. Anne-Sophie Carret: Employment: Seagen Inc.; Stock and Other Ownership Interests: Seagen Inc.; Honoraria: Seagen Inc.; Travel, Accommodations, Expenses: Seagen Inc. Jonathan E Rosenberg: Honoraria: UpToDate, Medscape, PeerView, Research to Practice, IntelliSphere, Clinical Care Options, Physicians' Education Resource, MJH Life Sciences, EMD Serono; Consulting or Advisory Role: Lilly, Merck, Roche/Genentech, AstraZeneca/MedImmune, Bristol Myers Squibb, Seagen Inc., Bayer, BioClin Therapeutics, QED Therapeutics, Pharmacyclics, GlaxoSmithKline, Janssen Oncology, Astellas Pharma, Boehringer Ingelheim, Pfizer/EMD Serono, Mirati Therapeutics, Immunomedics, Tyra Biosciences, Infinity Pharmaceuticals, Gilead Sciences, Hengrui Pharmaceuticals, Alligator Bioscience; Research Funding: Genentech/Roche (Institution), Seagen Inc. (Institution), Bayer (Institution), AstraZeneca (Institution), QED Therapeutics (Institution), Astellas Pharma (Institution); Patents, Royalties, Other Intellectual Property: Predictor of platinum sensitivity (Institution). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Writing and editorial support was provided by Ashfield MedComms (New York, NY, USA), an Inizio company, and was funded by Seagen Inc. and Astellas Pharma Inc. The authors had full control of this summary and provided their final approval of all content.
Open access
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