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<input type="email" aria-label="Recipient Email Address" placeholder="email@example.com" id="email-to" class="email-to" pattern="^[a-zA-Z0-9_.+-]+@[a-zA-Z0-9-]+\.[a-zA-Z0-9-.]+$" maxlength="100" required>
</div>
<div class="action-panel-control-wrap">
<label for="email-from" class="action-panel-label">
From:
</label>
<input type="email" aria-label="Sender Email Address" placeholder="email@example.com" id="email-from" class="email-from" pattern="^[a-zA-Z0-9_.+-]+@[a-zA-Z0-9-]+\.[a-zA-Z0-9-.]+$" maxlength="256">
</div>
<div class="action-panel-control-wrap">
<label for="email-citation-format" class="action-panel-label">
Format:
</label>
<select id="email-citation-format" name="citation-format" class="action-panel-selector email-citation-format">
<option selected="selected" value="summary">Summary</option>
<option value="summary-text">Summary (text)</option>
<option value="abstract">Abstract</option>
<option value="abstract-text">Abstract (text)</option>
</select>
</div>
<div class="include-supplemental-container">
<input type="checkbox" aria-label="Include MeSH and other data" name="include-supplemental" id="email-include-supplemental" class="email-include-supplemental">
<label for="email-include-supplemental" class="email-include-supplemental-label">MeSH and other data</label>
</div>
<div class="form-field recaptcha ">
<div class="g-recaptcha" id="id-recaptcha" data-sitekey="6LfsWHMdAAAAAClKbtOpjQ2pMjgsGxvv7NdZW9uI"></div>
</div>
<div id="captcha-error-message" class="usa-input-error-message captcha-validation-message" role="alert"></div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Sending..."
data-ga-category="save_share"
data-ga-action="email"
data-ga-label="send">
Send email
</button>
<button class="action-panel-cancel"
aria-label="Close 'Email citations' panel"
ref="linksrc=close_email_panel"
aria-controls="email-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="email"
data-ga-label="cancel">
Cancel
</button>
</div>
<input type="hidden" name="email-search-details" value="" />
<input type="hidden" name="email-search-details-hash" value="0e42663a6c3bd85498fcb88798998fed7bfdc45d457db35281e41afe13cc0524" />
</form>
</div>
</div>
<div id="collections-action-panel"
class="collections-action-panel action-panel in-progress-dots-panel"
aria-hidden="true"
data-collections-open-panel-enabled="false"
data-collections-open-panel-url-hash="#open-collections-panel">
<div class="inner-wrap">
<h3 class="action-panel-heading">
Add to Collections
</h3>
<form id="collections-action-panel-form"
class="collections-action-panel-form action-panel-content action-form action-panel-smaller-selectors"
data-existing-collections-url="/list-existing-collections/"
data-add-to-existing-collection-url="/add-to-existing-collection/"
data-create-and-add-to-new-collection-url="/create-and-add-to-new-collection/"
data-get-article-ids-by-search-url="/get-article-ids-by-search/"
data-myncbi-max-collection-name-length="100"
data-add-to-collection-max-amount="1000"
data-collections-root-url="https://www.ncbi.nlm.nih.gov/myncbi/collections/">
<input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz">
<div class="choice-group" role="radiogroup">
<ul class="radio-group-items">
<li>
<input type="radio"
id="collections-action-panel-new"
class="collections-new"
name="collections"
value="new"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="collections_radio_new">
<label for="collections-action-panel-new">Create a new collection</label>
</li>
<li>
<input type="radio"
id="collections-action-panel-existing"
class="collections-existing"
name="collections"
value="existing"
checked="true"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="collections_radio_existing">
<label for="collections-action-panel-existing">Add to an existing collection</label>
</li>
</ul>
</div>
<div class="controls-wrapper">
<div class="action-panel-control-wrap new-collections-controls">
<label for="collections-action-panel-add-to-new" class="action-panel-label required-field-asterisk">
Name your collection:
</label>
<input
type="text"
name="add-to-new-collection"
id="collections-action-panel-add-to-new"
class="collections-action-add-to-new"
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/"
maxlength="100"
data-ga-category="save_share"
data-ga-action="create_collection"
data-ga-label="non_favorties_collection">
<div class="collections-new-name-too-long usa-input-error-message selection-validation-message">
Name must be less than 100 characters
</div>
</div>
<div class="action-panel-control-wrap existing-collections-controls">
<label for="collections-action-panel-add-to-existing" class="action-panel-label">
Choose a collection:
</label>
<select id="collections-action-panel-add-to-existing"
class="action-panel-selector collections-action-add-to-existing"
data-ga-category="save_share"
data-ga-action="select_collection"
data-ga-label="($('#collections-action-add-to-existing').val() === 'Favorites') ? 'Favorites' : 'non_favorites_collection'">
</select>
<div class="collections-retry-load-on-error usa-input-error-message selection-validation-message">
Unable to load your collection due to an error<br>
<a href="#">Please try again</a>
</div>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Adding..."
data-pinger-ignore
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="add">
Add
</button>
<button class="action-panel-cancel"
aria-label="Close 'Add to Collections' panel"
ref="linksrc=close_collections_panel"
aria-controls="collections-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="collections"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="bibliography-action-panel"
class="bibliography-action-panel action-panel in-progress-dots-panel"
aria-hidden="true"
data-bibliography-open-panel-enabled="false"
data-bibliography-open-panel-url-hash="#open-bibliography-panel">
<div class="inner-wrap">
<h3 class="action-panel-heading">
Add to My Bibliography
</h3>
<form id="bibliography-action-panel-form"
class="bibliography-action-panel-form action-panel-content action-form action-panel-smaller-selectors"
data-add-to-bibliography-max-amount="100"
data-add-to-bibliography-batch-size="10"
data-bibliography-delegates-url="/list-bibliography-delegates/"
data-add-to-bibliography-url="/add-to-bibliography/"
data-get-article-ids-by-search-url="/get-article-ids-by-search/"
data-mybib-root-url="https://www.ncbi.nlm.nih.gov/myncbi/collections/mybibliography/">
<input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz">
<div class="action-panel-control-wrap bibliographies-controls">
<div class="choice-group">
<ul class="bibliographies-action-add radio-group-items">
<li>
<input name="bibliography" id="my-bibliography" class="my-bibliography" type="radio" checked/>
<label for="my-bibliography">My Bibliography</label>
</li>
</ul>
</div>
</div>
<div class="bibliographies-retry-load-on-error usa-input-error-message selection-validation-message">
Unable to load your delegates due to an error<br>
<a href="#">Please try again</a>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Adding..."
data-pinger-ignore>
Add
</button>
<button class="action-panel-cancel"
aria-label="Close 'Add to bibliography' panel"
ref="linksrc=close_bibliography_panel"
aria-controls="bibliography-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="mybib"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="saved-search-action-panel" class="saved-search-action-panel action-panel " aria-hidden="true"
data-saved-search-open-panel-enabled="false"
data-saved-search-open-panel-url-hash="#open-saved-search-panel">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Your saved search
</h2>
<form id="saved-search-action-panel-form"
class="saved-search-action-panel-form action-panel-content action-form"
data-create-saved-search-url="/create-saved-search/"
data-try-search-terms-url="/try-search-term/"
data-saved-search-root-url="https://www.ncbi.nlm.nih.gov/myncbi/searches/">
<input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz">
<div class="action-panel-control-wrap">
<label for="saved-search-name" class="action-panel-label saved-search-name-label required-field-asterisk">
Name of saved search:
</label>
<input maxlength="200"
type="text"
name="saved-search-name"
id="saved-search-name"
class="saved-search-name"
value=""
required
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/">
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-term" class="action-panel-label required-field-asterisk">
Search terms:
</label>
<textarea name="saved-search-term" id="saved-search-term" class="saved-search-term" required></textarea>
</div>
<div class="test-search-term-wrap">
<a href="#" class="try-search-term">Test search terms</a>
</div>
<div class="choice-group action-panel-extra-margin-top">
<span class="action-panel-label" id="fieldset-label">
Would you like email updates of new search results?
</span>
<fieldset id="saved-search-alert" aria-describedby="fieldset-label">
<legend class="usa-sr-only">Saved Search Alert Radio Buttons</legend>
<ul class="radio-group-items">
<li>
<input type="radio" id="saved-search-alert-yes" class="saved-search-alert-yes" name="saved-search-alert" value="yes" checked>
<label for="saved-search-alert-yes" class="action-panel-label">Yes</label>
</li>
<li>
<input aria-label="No radio input" type="radio" id="saved-search-alert-no" class="saved-search-alert-no" name="saved-search-alert" value="no">
<label for="saved-search-alert-no" class="action-panel-label">No</label>
</li>
</ul>
</fieldset>
</div>
<div class="alert-schedule-wrap">
<div class="action-panel-control-wrap">
<label class="action-panel-label">
Email:
</label>
<span aria-label="Email address" id="saved-search-email" class="action-panel-label"><span class="action-panel-label-bold"></span> (<a class="myncbi-account-settings" href="https://www.ncbi.nlm.nih.gov/account/settings/">change</a>)</span>
</div>
<div class="action-panel-control-wrap action-panel-extra-margin-top">
<label for="saved-search-frequency" class="action-panel-label">
Frequency:
</label>
<select id="saved-search-frequency" class="no-border-panel-selector saved-search-frequency">
<option value="monthly">Monthly</option>
<option value="weekly">Weekly</option>
<option value="daily">Daily</option>
</select>
</div>
<div class="action-panel-control-wrap saved-search-monthly-additional">
<label for="saved-search-monthly-on-day" class="action-panel-label">
Which day?
</label>
<select id="saved-search-monthly-on-day" class="no-border-panel-selector">
<option value="Sunday">The first Sunday</option>
<option value="Monday">The first Monday</option>
<option value="Tuesday">The first Tuesday</option>
<option value="Wednesday">The first Wednesday</option>
<option value="Thursday">The first Thursday</option>
<option value="Friday">The first Friday</option>
<option value="Saturday">The first Saturday</option>
<option value="day">The first day</option>
<option value="weekday">The first weekday</option>
</select>
</div>
<div class="action-panel-control-wrap saved-search-weekly-additional">
<label for="saved-search-weekly-on-day" class="action-panel-label">
Which day?
</label>
<select id="saved-search-weekly-on-day" class="no-border-panel-selector saved-search-weekly-on-day">
<option value="Sunday">Sunday</option>
<option value="Monday">Monday</option>
<option value="Tuesday">Tuesday</option>
<option value="Wednesday">Wednesday</option>
<option value="Thursday">Thursday</option>
<option value="Friday">Friday</option>
<option value="Saturday">Saturday</option>
</select>
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-report" class="action-panel-label">
Report format:
</label>
<select id="saved-search-report" class="no-border-panel-selector saved-search-report">
<option value="DocSum">Summary</option>
<option value="DocSumText">Summary (text)</option>
<option value="Abstract">Abstract</option>
<option value="AbstractText">Abstract (text)</option>
<option value="MEDLINE">PubMed</option>
</select>
</div>
<div class="action-panel-control-wrap">
<label for="saved-search-amount" class="action-panel-label">
Send at most:
</label>
<select id="saved-search-amount" class="no-border-panel-selector saved-search-amount">
<option value="1">1 item</option>
<option value="5" selected>5 items</option>
<option value="10">10 items</option>
<option value="20">20 items</option>
<option value="50">50 items</option>
<option value="100">100 items</option>
<option value="200">200 items</option>
</select>
</div>
<div>
<input type="checkbox" id="saved-search-send-if-no-result" class="saved-search-send-if-no-result" name="saved-search-send-if-no-result">
<label for="saved-search-send-if-no-result" class="action-panel-label smaller-checkbox">
Send even when there aren't any new results
</label>
</div>
<div class="action-panel-control-wrap option-text-in-email-wrap">
<label for="saved-search-email-text" class="action-panel-label">
Optional text in email:
</label>
<textarea name="saved-search-email-text"
id="saved-search-email-text"
class="saved-search-email-text"></textarea>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Saving..."
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="save">
Save
</button>
<button class="action-panel-cancel"
aria-label="Close 'Your saved search' panel"
ref="linksrc=close_saved_search_panel"
aria-controls="saved-search-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="citation-manager-action-panel" class="citation-manager-action-panel action-panel" aria-hidden="true">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Create a file for external citation management software
</h2>
<form id="citation-manager-action-panel-form"
class="action-panel-content action-form"
action="/results-export-ids/"
data-by-search-action="/results-export-search-data/"
data-by-ids-action="/results-export-ids/"
method="post"
data-by-search-method="post"
data-by-ids-method="post">
<input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz">
<input name="results-format" type="hidden" value="pubmed"/>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Sending..."
data-ga-category="save_share"
data-ga-action="citation_manager"
data-ga-label="save">
Create file
</button>
<button class="action-panel-cancel"
aria-label="Close 'Send citations to citation manager' panel"
ref="linksrc=close_citation_manager_panel"
aria-controls="citation-manager-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="citation_manager"
data-ga-label="cancel">
Cancel
</button>
</div>
</form>
</div>
</div>
<div id="rss-action-panel" class="rss-action-panel action-panel " aria-hidden="true">
<div class="inner-wrap">
<h2 class="action-panel-heading">
Your RSS Feed
</h2>
<form id="rss-action-panel-form"
class="rss-action-panel-form action-panel-content action-form"
data-create-rss-feed-url="/create-rss-feed-url/"
data-search-form-term-value="">
<input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz">
<div class="action-panel-control-wrap">
<label for="rss-name" class="action-panel-label required-field-asterisk">
Name of RSS Feed:
</label>
<input maxlength="200"
placeholder="Name"
type="text"
name="rss-name"
id="rss-name"
class="rss-name"
value=''
required
pattern="[^&quot;&amp;=&lt;&gt;\/]*" title="The following characters are not allowed in the Name field: &quot;&amp;=&lt;&gt;/">
</div>
<div class="rss-limit-wrap">
<div class="action-panel-control-wrap action-panel-extra-margin-top">
<label for="rss-limit" class="action-panel-label">
Number of items displayed:
</label>
<select id="rss-limit" class="no-border-panel-selector rss-limit">
<option value="5">5</option>
<option value="10">10</option>
<option value="15" selected="selected">15</option>
<option value="20">20</option>
<option value="50">50</option>
<option value="100">100</option>
</select>
</div>
</div>
<div class="action-panel-actions">
<button class="action-panel-submit"
type="submit"
data-loading-label="Creating..."
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="save">
Create RSS
</button>
<button class="action-panel-cancel"
aria-label="Close 'Your RSS' panel"
ref="linksrc=close_rss_panel"
aria-controls="rss-action-panel"
aria-expanded="false"
data-ga-category="save_share"
data-ga-action="alert"
data-ga-label="cancel">
Cancel
</button>
</div>
<div class="action-panel-control-wrap rss-link-copy-wrap">
<label for="rss-link" class="usa-sr-only">RSS Link</label>
<input placeholder="Your RSS Feed Link" type="text" name="rss-link" id="rss-link" class="rss-link" title="RSS Link">
<button
type="button"
disabled
class="rss-link-copy-button disabled"
data-ga-category="save_share"
data-ga-action="rss"
data-ga-label="copy">
Copy
</button>
</div>
</form>
</div>
</div>
</div>
</div>
<div class="article-page" id="article-page" data-article-pmid="31356140">
<aside class="page-sidebar">
<div class="inner-wrap">
<div class="full-text-links">
<div class="full-view">
<h3 class="title">
Full text links
</h3>
<div class="full-text-links-list">
<a class="link-item
dialog-focus"
href="https://ascopubs.org/doi/10.1200/JCO.19.01140?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub 0pubmed"
target="_blank"
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ref="linksrc=fulltextorjournal_fulltext&amp;is_pmc=False&amp;PrId=4487&amp;itool=Abstract-def&amp;log$=linkouticon&amp;uid=31356140&amp;db=pubmed&amp;nlmid=8309333"
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Atypon
</span></a><a class="link-item
pmc
"
href="https://pmc.ncbi.nlm.nih.gov/articles/pmid/31356140/"
target="_blank"
rel="noopener"
ref="linksrc=fulltextorjournal_fulltext&amp;is_pmc=True&amp;PrId=3494&amp;itool=Abstract-def&amp;log$=linkouticon&amp;uid=31356140&amp;db=pubmed&amp;nlmid=8309333"
title="Free full text at PubMed Central"
data-ga-category="full_text"
data-ga-action="PMC"
data-ga-label="31356140"
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Free PMC article
</span></a>
</div>
</div>
<div class="short-view">
<a href="#" class="full-text-links-button full-text-links-dialog-trigger">
Full text links
</a>
</div>
</div>
<div class="actions-buttons sidebar"><h3 class="title">Actions</h3><div class="inner-wrap"><button class="citation-button citation-dialog-trigger"
aria-label="Open dialog with citation text in different styles"
data-ga-category="save_share"
data-ga-action="cite"
data-ga-label="open"
data-all-citations-url="/31356140/citations/"
data-citation-style="nlm"
data-pubmed-format-link="/31356140/export/"><span class="button-label">Cite</span></button><link type="text/css" href="ncbi-overlay-block/src/overlay-block.css"><div class="collections-button-container" data-article-id="31356140" data-article-db="pubmed"><button class="collections-button collections-dialog-trigger"
aria-label="Save article in MyNCBI collections."
data-ga-category="collections_button"
data-ga-action="click"
data-ga-label="collections_button"
data-collections-open-dialog-enabled="false"
data-collections-open-dialog-url="https://account.ncbi.nlm.nih.gov/?back_url=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F31356140%2F%23open-collections-dialog"
data-in-collections="false"><span class="button-label">Collections</span></button><div class="overlay" role="dialog"><div id="collections-action-dialog"
class="dialog collections-dialog"
aria-hidden="true"><div class="title">Add to Collections</div><div class="collections-action-panel action-panel"><form id="collections-action-dialog-form"
class="collections-action-panel-form action-panel-content action-form action-panel-smaller-selectors"
data-existing-collections-url="/list-existing-collections/"
data-add-to-existing-collection-url="/add-to-existing-collection/"
data-create-and-add-to-new-collection-url="/create-and-add-to-new-collection/"
data-myncbi-max-collection-name-length="100"
data-collections-root-url="https://www.ncbi.nlm.nih.gov/myncbi/collections/"><input type="hidden" name="csrfmiddlewaretoken" value="vV4O4I1vwpweCc5bAH3sblNa3JNN372fMIOTHyuR60jIwDb1d0GuFtjOBNvZWIAz"><div class="choice-group" role="radiogroup"><ul class="radio-group-items"><li><input type="radio"
id="collections-action-dialog-new"
class="collections-new"
name="collections"
value="new"
data-ga-category="collections_button"
data-ga-action="click"
data-ga-label="collections_radio_new"><label for="collections-action-dialog-new">Create a new collection</label></li><li><input type="radio"
id="collections-action-dialog-existing"
class="collections-existing"
name="collections"
value="existing"
checked="true"
data-ga-category="collections_button"
data-ga-action="click"
data-ga-label="collections_radio_existing"><label for="collections-action-dialog-existing">Add to an existing collection</label></li></ul></div><div class="controls-wrapper"><div class="action-panel-control-wrap new-collections-controls"><label for="collections-action-dialog-add-to-new" class="action-panel-label required-field-asterisk">
Name your collection:
</label><input
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<h1 class="heading-title">
Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy
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Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy
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<span class="authors-list-item "><a class="full-name"
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1
</a><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Weill Cornell Medical College, New York, NY." href="#short-view-affiliation-2" ref="linksrc=author_aff">
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><sup class="key">2</sup> Weill Cornell Medical College, New York, NY.</li>
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><sup class="key">3</sup> University of Chicago, Chicago, IL.</li>
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><sup class="key">4</sup> New York University Langone Health, New York, NY.</li>
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><sup class="key">5</sup> Dana-Farber Cancer Institute, Boston, MA.</li>
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><sup class="key">6</sup> Wayne State University, Detroit, MI.</li>
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><sup class="key">7</sup> Fred Hutchinson Cancer Research Center, Seattle, WA.</li>
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><sup class="key">8</sup> University of Washington, Seattle, WA.</li>
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><sup class="key">9</sup> Icahn School of Medicine at Mount Sinai, New York, NY.</li>
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><sup class="key">10</sup> Johns Hopkins University School of Medicine, Baltimore, MD.</li>
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><sup class="key">11</sup> Seattle Genetics, Bothell, WA.</li>
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><sup class="key">12</sup> Astellas Pharma, Northbrook, IL.</li>
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><sup class="key">13</sup> Yale Cancer Center, New Haven, CT.</li>
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Purpose:
</strong>
Locally advanced or metastatic urothelial carcinoma is an incurable disease with limited treatment options, especially for patients who were previously treated with platinum and anti-programmed death 1 or anti-programmed death ligand 1 (PD-1/L1) therapy. Enfortumab vedotin is an antibody-drug conjugate that targets Nectin-4, which is highly expressed in urothelial carcinoma.
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EV-201 is a global, phase II, single-arm study of enfortumab vedotin 1.25 mg/kg (intravenously on days 1, 8, and 15 of every 28-day cycle) in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum chemotherapy and anti-PD-1/L1 therapy. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review. Key secondary end points were duration of response, progression-free survival, overall survival, safety, and tolerability.
</p>
<p>
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Results:
</strong>
Enfortumab vedotin was administered to 125 patients with metastatic urothelial carcinoma. Median follow-up was 10.2 months (range, 0.5 to 16.5 months). Confirmed objective response rate was 44% (95% CI, 35.1% to 53.2%), including 12% complete responses. Similar responses were observed in prespecified subgroups, such as those patients with liver metastases and those with no response to prior anti-PD-1/L1 therapy. Median duration of response was 7.6 months (range, 0.95 to 11.30+ months). The most common treatment-related adverse events were fatigue (50%), any peripheral neuropathy (50%), alopecia (49%), any rash (48%), decreased appetite (44%), and dysgeusia (40%). No single treatment-related adverse events grade 3 or greater occurred in 10% or more of patients.
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Conclusion:
</strong>
Enfortumab vedotin demonstrated a clinically meaningful response rate with a manageable and tolerable safety profile in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum and anti-PD-1/L1 therapies.
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ClinicalTrials.gov <a href="http://clinicaltrials.gov/show/NCT03219333" title="See in ClinicalTrials.gov">NCT03219333</a>.
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data-pmc-id="PMC6784850"
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<img class="figure-thumb" itemprop="thumbnail"
id="article-image-0"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/77ec48ca3603/JCO.19.01140f1.gif"
alt="FIG 1." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="820">
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<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
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<p> FIG 1. </p>
</strong>
<div class="figure-caption-contents"><p> CONSORT diagram. Three patients were… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG 1. </p>
</strong>
<div class="figure-caption-contents"><p> CONSORT diagram. Three patients were discontinued from the study before receiving study treatment;… </p></div>
</div>
<figcaption id="figure-caption-0" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG 1.
</strong>
<div class="figure-caption-contents">CONSORT diagram. Three patients were discontinued from the study before receiving study treatment; 1 due to clinical deterioration, 1 per patient decision, and 1 due to low hemoglobin levels after screening and enrollment. This latter patient met all eligibility criteria, including adequate hemoglobin level and was enrolled in the study; however, the patients hemoglobin levels were subsequently found to be low and the investigator withdrew the patient from the study as a result.</div>
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itemprop="contentUrl"
aria-describedby="figure-caption-1"
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data-image-width="758"
data-image-height="1042"
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data-pmc-id="PMC6784850"
data-figure-id="f2">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-1"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/6cc1c251abdc/JCO.19.01140f2.gif"
alt="FIG 2." />
</a>
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<strong class="figure-label">
<p> FIG 2. </p>
</strong>
<div class="figure-caption-contents"><p> Response among patients with metastatic… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG 2. </p>
</strong>
<div class="figure-caption-contents"><p> Response among patients with metastatic urothelial carcinoma per blinded independent central review. (A)… </p></div>
</div>
<figcaption id="figure-caption-1" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG 2.
</strong>
<div class="figure-caption-contents">Response among patients with metastatic urothelial carcinoma per blinded independent central review. (A) Swimmer plot of the objective responses (n = 55) (according to RECIST v1.1.) from the start of treatment to disease progression, as determined by blinded independent central review, or death. At the time of analysis, 44% of responders had ongoing responses. (B) Waterfall plot of the best percentage of change from baseline in the sum of the diameters of target lesions as identified per RECIST v1.1. Target lesions were reduced in 84% of patients (92 of 110) who were evaluable—that is, had target lesions and adequate postbaseline assessment). Dashed line indicates threshold for partial response (30%), but is not necessarily indicative of response. CR, complete response; ORR, overall response rate; PR, partial response.</div>
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itemprop="contentUrl"
aria-describedby="figure-caption-2"
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data-image-width="760"
data-image-height="624"
data-image-alt="FIG 3."
data-pmc-id="PMC6784850"
data-figure-id="f3">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-2"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/76b527ae0f20/JCO.19.01140f3.gif"
alt="FIG 3." />
</a>
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<p> FIG 3. </p>
</strong>
<div class="figure-caption-contents"><p> Objective response in key prespecified… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG 3. </p>
</strong>
<div class="figure-caption-contents"><p> Objective response in key prespecified subgroups per blinded independent central review. This prespecified… </p></div>
</div>
<figcaption id="figure-caption-2" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG 3.
</strong>
<div class="figure-caption-contents">Objective response in key prespecified subgroups per blinded independent central review. This prespecified subgroup analysis was performed on the full analysis set of all patients who received any amount of enfortumab vedotin (N = 125). Historical control response rate is 10%, as indicated by dashed line. The programmed death ligand 1 (PD-L1) combined positive score (CPS) was defined as the percentage of tumor and infiltrating immune cells with PD-L1 expression of the total number of tumor cells. The upper tract was defined as the renal pelvis, ureter, and kidney. Data are given as No. (%), unless otherwise noted. (†) Bellmunt risk score was not available for 1 patient. (‡) Anti-PD-1 or anti-PD-L1 therapy. (§) Five patients did not have tumor samples evaluable for PD-L1 expression levels. ECOG, Eastern Cooperative Oncology Group; ORR, objective response rate; UC, urothelial carcinoma.</div>
</figcaption>
</figure>
<figure class="figure-item "
itemscope itemtype="http://schema.org/ImageObject"
itemprop="associatedMedia"
data-slide-index="3"
data-label-slug="fig-a1">
<a class="figure-link"
href="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/35aebd0cc0be/JCO.19.01140app1.jpg"
itemprop="contentUrl"
aria-describedby="figure-caption-3"
role="button"
data-image-width="791"
data-image-height="560"
data-image-alt="FIG A1."
data-pmc-id="PMC6784850"
data-figure-id="fA.1">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-3"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/36cbd1b02f1d/JCO.19.01140app1.gif"
alt="FIG A1." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="791">
<meta itemprop="height" itemtype="http://schema.org/ImageObject" content="560">
<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
<div class="caption-wrap">
<strong class="figure-label">
<p> FIG A1. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of duration of… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A1. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of duration of response for responders per blinded independent central review.… </p></div>
</div>
<figcaption id="figure-caption-3" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A1.
</strong>
<div class="figure-caption-contents">Kaplan-Meier estimate of duration of response for responders per blinded independent central review. PD, progressive disease.</div>
</figcaption>
</figure>
<figure class="figure-item "
itemscope itemtype="http://schema.org/ImageObject"
itemprop="associatedMedia"
data-slide-index="4"
data-label-slug="fig-a2">
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href="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/929a6581cd5f/JCO.19.01140app2.jpg"
itemprop="contentUrl"
aria-describedby="figure-caption-4"
role="button"
data-image-width="805"
data-image-height="570"
data-image-alt="FIG A2."
data-pmc-id="PMC6784850"
data-figure-id="fA.2">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-4"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/a5b770b50e0e/JCO.19.01140app2.gif"
alt="FIG A2." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="805">
<meta itemprop="height" itemtype="http://schema.org/ImageObject" content="570">
<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
<div class="caption-wrap">
<strong class="figure-label">
<p> FIG A2. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of duration of… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A2. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of duration of response for responders per investigator assessment. PD, progressive… </p></div>
</div>
<figcaption id="figure-caption-4" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A2.
</strong>
<div class="figure-caption-contents">Kaplan-Meier estimate of duration of response for responders per investigator assessment. PD, progressive disease.</div>
</figcaption>
</figure>
<figure class="figure-item "
itemscope itemtype="http://schema.org/ImageObject"
itemprop="associatedMedia"
data-slide-index="5"
data-label-slug="fig-a3">
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href="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/f216c4783d40/JCO.19.01140app3.jpg"
itemprop="contentUrl"
aria-describedby="figure-caption-5"
role="button"
data-image-width="768"
data-image-height="446"
data-image-alt="FIG A3."
data-pmc-id="PMC6784850"
data-figure-id="fA.3">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-5"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/e00445bbc320/JCO.19.01140app3.gif"
alt="FIG A3." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="768">
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<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
<div class="caption-wrap">
<strong class="figure-label">
<p> FIG A3. </p>
</strong>
<div class="figure-caption-contents"><p> Waterfall plot of the best… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A3. </p>
</strong>
<div class="figure-caption-contents"><p> Waterfall plot of the best percentage change from baseline of target lesions per… </p></div>
</div>
<figcaption id="figure-caption-5" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A3.
</strong>
<div class="figure-caption-contents">Waterfall plot of the best percentage change from baseline of target lesions per investigator. Waterfall plot of the best percentage of change from baseline in the sum of the diameters of target lesions according to RECIST, version 1.1, per investigator. Overall, 114 patients were evaluable for target lesion response, and 11 patients were not evaluable. Dashed line indicates approximate threshold for partial response (30%), but is not necessarily indicative of response. ORR, overall response rate.</div>
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data-label-slug="fig-a4">
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itemprop="contentUrl"
aria-describedby="figure-caption-6"
role="button"
data-image-width="791"
data-image-height="557"
data-image-alt="FIG A4."
data-pmc-id="PMC6784850"
data-figure-id="fA.4">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-6"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/e9ea4750a198/JCO.19.01140app4.gif"
alt="FIG A4." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="791">
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<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
<div class="caption-wrap">
<strong class="figure-label">
<p> FIG A4. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of progression-free survival… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A4. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of progression-free survival per investigator in the full analysis set. </p></div>
</div>
<figcaption id="figure-caption-6" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A4.
</strong>
<div class="figure-caption-contents">Kaplan-Meier estimate of progression-free survival per investigator in the full analysis set.</div>
</figcaption>
</figure>
<figure class="figure-item tail"
itemscope itemtype="http://schema.org/ImageObject"
itemprop="associatedMedia"
data-slide-index="7"
data-label-slug="fig-a5">
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itemprop="contentUrl"
aria-describedby="figure-caption-7"
role="button"
data-image-width="794"
data-image-height="580"
data-image-alt="FIG A5."
data-pmc-id="PMC6784850"
data-figure-id="fA.5">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-7"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/8962fc19fe1c/JCO.19.01140app5.gif"
alt="FIG A5." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="794">
<meta itemprop="height" itemtype="http://schema.org/ImageObject" content="580">
<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
<div class="caption-wrap">
<strong class="figure-label">
<p> FIG A5. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of progression-free survival… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A5. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of progression-free survival per blinded independent central review in the full… </p></div>
</div>
<figcaption id="figure-caption-7" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A5.
</strong>
<div class="figure-caption-contents">Kaplan-Meier estimate of progression-free survival per blinded independent central review in the full analysis set.</div>
</figcaption>
</figure>
<figure class="figure-item tail"
itemscope itemtype="http://schema.org/ImageObject"
itemprop="associatedMedia"
data-slide-index="8"
data-label-slug="fig-a6">
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itemprop="contentUrl"
aria-describedby="figure-caption-8"
role="button"
data-image-width="798"
data-image-height="567"
data-image-alt="FIG A6."
data-pmc-id="PMC6784850"
data-figure-id="fA.6">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-8"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ef5/6784850/1d0b8bd5a832/JCO.19.01140app6.gif"
alt="FIG A6." />
</a>
<meta itemprop="width" itemtype="http://schema.org/ImageObject" content="798">
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<div class="figure-caption figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="caption" aria-hidden="true">
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<strong class="figure-label">
<p> FIG A6. </p>
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<div class="figure-caption-contents"><p> Kaplan-Meier estimate of overall survival… </p></div>
</div>
</div>
<div class="figure-caption-medium figure-caption-text" aria-hidden="true">
<strong class="figure-label">
<p> FIG A6. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier estimate of overall survival in the full analysis set. </p></div>
</div>
<figcaption id="figure-caption-8" class="figure-caption-full figure-caption-text" itemtype="http://schema.org/ImageObject" itemprop="description">
<strong class="figure-label">
FIG A6.
</strong>
<div class="figure-caption-contents">Kaplan-Meier estimate of overall survival in the full analysis set.</div>
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Immunotherapy for Urothelial Cancer: Where Are the Randomized Trials?
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<span class="docsum-authors full-authors">Vera-Badillo FE, Tannock IF, Booth CM.</span>
<span class="docsum-authors short-authors">Vera-Badillo FE, et al.</span>
<span class="docsum-journal-citation full-journal-citation">J Clin Oncol. 2019 Oct 10;37(29):2587-2591. doi: 10.1200/JCO.18.02257. Epub 2019 Jul 1.</span>
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<span class="docsum-journal-citation full-journal-citation">Nat Rev Clin Oncol. 2019 Oct;16(10):591. doi: 10.1038/s41571-019-0263-8.</span>
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<span class="docsum-journal-citation full-journal-citation">J Clin Oncol. 2020 Feb 20;38(6):651-652. doi: 10.1200/JCO.19.02830. Epub 2019 Dec 27.</span>
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