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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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU">
<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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU">
<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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU">
<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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU">
<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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU">
<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>
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<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.20.03489?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub 0pubmed"
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rel="noopener"
ref="linksrc=fulltextorjournal_fulltext&amp;is_pmc=True&amp;PrId=3494&amp;itool=Abstract-def&amp;log$=linkouticon&amp;uid=33929895&amp;db=pubmed&amp;nlmid=8309333"
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Free PMC article
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<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="/33929895/citations/"
data-citation-style="nlm"
data-pubmed-format-link="/33929895/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="33929895" 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%2F33929895%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="litaMqHvQKKipsG9G8QWj5PBG9sEiM7AC5dfpgaRqlxMjTMZjrtYNdlfedaQbnFU"><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
type="text"
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<h1 class="heading-title">
TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors
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><sup class="key">8</sup> Huntsman Cancer Hospital, Salt Lake City, UT.</li>
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><sup class="key">9</sup> Rocky Mountain Cancer Centers, Littleton, CO.</li>
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><sup class="key">10</sup> Hôpitaux Universitaires de Strasbourg/Institut de Cancérologie Strasbourg Europe, Strasbourg, France.</li>
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><sup class="key">12</sup> University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.</li>
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><sup class="key">13</sup> University of Wisconsin Carbone Cancer Center, Madison, WI.</li>
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><sup class="key">14</sup> Institut Claudius Regaud/Cancer Comprehensive Center, IUCT, Toulouse, France.</li>
<li data-affiliation-id="full-view-affiliation-15"
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><sup class="key">15</sup> Immunomedics, a subsidiary of Gilead Sciences, Inc, Morris Plains, NJ.</li>
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><sup class="key">16</sup> Fred Hutchinson Cancer Research Center, University of Washington, Seattle Cancer Care Alliance, Seattle, WA.</li>
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<div class="publication-type" >Clinical Trial</div>
<h1 class="heading-title">
TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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</a></sup><span class="comma">,&nbsp;</span></span><span class="authors-list-item "><a class="full-name"
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data-ga-label="Cora N Sternberg">Cora N Sternberg</a><sup class="affiliation-links"><span class="author-sup-separator">&nbsp;</span><a class="affiliation-link" title="Weill Cornell Medicine, New York, NY." href="#short-view-affiliation-1" ref="linksrc=author_aff">
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><sup class="key">2</sup> Perlmutter Cancer Center at NYU Langone Health, New York, NY.</li>
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><sup class="key">3</sup> Smilow Cancer Center, Yale School of Medicine, New Haven, CT.</li>
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><sup class="key">4</sup> Norton Cancer Institute, Louisville, KY.</li>
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><sup class="key">5</sup> Institut de Cancérologie Gustave Roussy, Villejuif, France.</li>
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><sup class="key">6</sup> Centre Léon Bérard, Lyon, France.</li>
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><sup class="key">7</sup> H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.</li>
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><sup class="key">8</sup> Huntsman Cancer Hospital, Salt Lake City, UT.</li>
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><sup class="key">9</sup> Rocky Mountain Cancer Centers, Littleton, CO.</li>
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><sup class="key">11</sup> Hôpital Foch, Suresnes, France.</li>
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><sup class="key">12</sup> University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.</li>
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><sup class="key">13</sup> University of Wisconsin Carbone Cancer Center, Madison, WI.</li>
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><sup class="key">14</sup> Institut Claudius Regaud/Cancer Comprehensive Center, IUCT, Toulouse, France.</li>
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><sup class="key">15</sup> Immunomedics, a subsidiary of Gilead Sciences, Inc, Morris Plains, NJ.</li>
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><sup class="key">16</sup> Fred Hutchinson Cancer Research Center, University of Washington, Seattle Cancer Care Alliance, Seattle, WA.</li>
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Abstract
</h2>
<div class="abstract-content selected"
id="eng-abstract">
<p>
<strong class="sub-title">
Purpose:
</strong>
Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2-directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.
</p>
<p>
<strong class="sub-title">
Methods:
</strong>
TROPHY-U-01 (ClinicalTrials.gov identifier: <a href="http://clinicaltrials.gov/show/NCT03547973" title="See in ClinicalTrials.gov">NCT03547973</a>) is a multicohort, open-label, phase II, registrational study. Cohort 1 includes patients with locally advanced or unresectable or mUC who had progressed after prior PLT and CPI. Patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. The primary outcome was centrally reviewed ORR; secondary outcomes were progression-free survival, OS, duration of response, and safety.
</p>
<p>
<strong class="sub-title">
Results:
</strong>
Cohort 1 included 113 patients (78% men; median age, 66 years; 66.4% visceral metastases; median of three [range, 1-8] prior therapies). At a median follow-up of 9.1 months, the ORR was 27% (31 of 113; 95% CI, 19.5 to 36.6); 77% had decrease in measurable disease. Median duration of response was 7.2 months (95% CI, 4.7 to 8.6 months), with median progression-free survival and OS of 5.4 months (95% CI, 3.5 to 7.2 months) and 10.9 months (95% CI, 9.0 to 13.8 months), respectively. Key grade ≥ 3 treatment-related adverse events included neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%), with 6% discontinuing treatment because of treatment-related adverse events.
</p>
<p>
<strong class="sub-title">
Conclusion:
</strong>
SG is an active drug with a manageable safety profile with most common toxicities of neutropenia and diarrhea. SG has notable efficacy compared with historical controls in pretreated mUC that has progressed on both prior PLT regimens and CPI. The results from this study supported accelerated approval of SG in this population.
</p>
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<h2 class="title">
Conflict of interest statement
</h2>
<div class="statement">
<p xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:p1="http://pubmed.gov/pub-one"><bold>Scott Tagawa</bold><bold>Consulting or Advisory Role:</bold> Medivation, Astellas Pharma, Dendreon, Janssen, Bayer, Genentech, Endocyte, Immunomedics, Karyopharm Therapeutics, Abbvie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seattle Genetics, AIkido Pharma<bold>Research Funding:</bold> Lilly, Sanofi, Janssen, Astellas Pharma, Progenics, Millennium, Amgen, Bristol-Myers Squibb, Dendreon, Rexahn Pharmaceuticals, Bayer, Genentech, Newlink Genetics, Inovio Pharmaceuticals, AstraZeneca, Immunomedics, Novartis, AVEO, Boehringer Ingelheim, Merck, Stem CentRx, Karyopharm Therapeutics, Abbvie, Medivation, Endocyte, Exelixis, Clovis Oncology<bold>Travel, Accommodations, Expenses:</bold> Sanofi, Immunomedics, Amgen<bold>Uncompensated Relationships:</bold> Telix Pharmaceuticals, ATLAB Pharma, Phosplatin Therapeutics <bold>Arjun Balar</bold><bold>Honoraria:</bold> Merck, Genentech/Roche, AstraZeneca/MedImmune<bold>Consulting or Advisory Role:</bold> Immunomedics, Bristol Myers Squibb, Genentech/Roche, Merck, Cerulean Pharma, AstraZeneca/MedImmune, Pfizer/EMD Serono, Incyte, Seattle Genetics/Astellas, Nektar, Dragonfly Therapeutics, GlaxoSmithKline<bold>Research Funding:</bold> Immunomedics, Merck, Genentech/Roche, AstraZeneca/MedImmune, Seattle Genetics <bold>Daniel Petrylak</bold><bold>Stock and Other Ownership Interests:</bold> Bellicum Pharmaceuticals, TYME<bold>Consulting or Advisory Role:</bold> Bayer, Exelixis, Pfizer, Roche, Astellas Pharma, AstraZeneca, Lilly, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Incyte, Janssen, Pharmacyclics, Seattle Genetics, Urogen pharma, Advanced Accelerator Applications, Ipsen, Bicycle Therapeutics, Mirati Therapeutics, Monopteros Therapeutics<bold>Research Funding:</bold> Progenics, Sanofi, Endocyte, Genentech, Merck, Astellas Medivation, Novartis, AstraZeneca, Bayer, Lilly, Innocrin Pharma, MedImmune, Pfizer, Roche, Seattle Genetics, Clovis Oncology, Bristol Myers Squibb, Advanced Accelerator Applications, Agensys, BioXCel therapeutics, Eisai, Mirati Therapeutics, Replimune<bold>Expert Testimony:</bold> Celgene, sanofi <bold>Arash Rezazadeh</bold><bold>Stock and Other Ownership Interests:</bold> ECOM Medical<bold>Consulting or Advisory Role:</bold> Exelixis, AstraZeneca, Bayer, Pfizer, Novartis, Genentech, Bristol Myers Squibb, EMD Serono, Immunomedics, Gilead Sciences<bold>Speakers' Bureau:</bold> Janssen, Astellas Medivation, Pfizer, Novartis, Sanofi, Genentech/Roche, Eisai, AstraZeneca, Bristol Myers Squibb, Amgen, Exelixis, Exelixis, EMD Serono, Merck, Seattle Genetics/Astellas, Seattle Genetics/Astellas, Myovant Sciences, Gilead Sciences, AVEO<bold>Research Funding:</bold> Genentech, Exelixis, Janssen, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Macrogenics, Astellas Pharma, BeyondSpring Pharmaceuticals, BioClin Therapeutics, Clovis Oncology, Bavarian Nordic, Seattle Genetics, Immunomedics, Epizyme<bold>Travel, Accommodations, Expenses:</bold> Genentech, Prometheus, Astellas Medivation, Janssen, Eisai, Bayer, Pfizer, Novartis, Exelixis, AstraZeneca <bold>Yohann Loriot</bold><bold>Honoraria:</bold> Sanofi, Pfizer<bold>Consulting or Advisory Role:</bold> Janssen, Astellas Pharma, Roche, AstraZeneca, MSD Oncology, MSD Oncology, Seattle Genetics, Bristol Myers Squibb, Immunomedics, Taiho Pharmaceutical<bold>Research Funding:</bold> Sanofi, Janssen Oncology, MSD Oncology, AstraZeneca, Clovis Oncology, Exelixis, Boehringer Ingelheim, Incyte, Pfizer, Oncogenex, Medivation, CureVac, Nektar<bold>Travel, Accommodations, Expenses:</bold> Astellas Pharma, Janssen Oncology, Roche, MSD Oncology, AstraZeneca, Seattle Genetics <bold>Aude Flechon</bold><bold>Honoraria:</bold> MSD Oncology, AstraZeneca, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, Pfizer, Sanofi/Aventis, Roche/Genentech, Bayer, Ipsen, AAA HealthCare<bold>Travel, Accommodations, Expenses:</bold> Astellas Pharma, Sanofi/Aventis, Janssen-Cilag, Bayer, Pfizer, Ipsen, Bristol Myers Squibb, AstraZeneca, MSD Oncology, Roche/Genentech, AAA HealthCare <bold>Rohit Jain</bold><bold>Honoraria:</bold> Alphasights<bold>Consulting or Advisory Role:</bold> Taiho Oncology, Pfizer, Seattle Genetics/Astellas, Gilead Sciences, EMD Serono<bold>Speakers' Bureau:</bold> Seattle Genetics/Astellas <bold>Neeraj Agarwal</bold><bold>Consulting or Advisory Role:</bold> Pfizer, Medivation/Astellas, Bristol Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Foundation One Inc, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Lilly, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma<bold>Research Funding:</bold> Bayer, Bristol Myers Squibb, GlaxoSmithKline, Takeda, Novartis, Pfizer, BN ImmunoTherapeutics, Exelixis, TRACON Pharma, Rexahn Pharmaceuticals, Amgen, AstraZeneca, Active Biotech, Bavarian Nordic, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Newlink Genetics, Prometheus, Sanofi <bold>Manojkumar Bupathi</bold><bold>Honoraria:</bold> Bristol Myers Squibb, Exelixis, AstraZeneca, Pfizer, Astellas Pharma<bold>Consulting or Advisory Role:</bold> Bristol Myers Squibb, AstraZeneca, Exelixis<bold>Speakers' Bureau:</bold> AstraZeneca, Bristol Myers Squibb, Pfizer, Exelixis, Astellas Pharma <bold>Philippe Barthelemy</bold><bold>Honoraria:</bold> Ipsen, Bristol Myers Squibb, MSD, Astellas Pharma, Janssen-Cilag, Pfizer, Merck KGaA<bold>Consulting or Advisory Role:</bold> Ipsen, Bristol Myers Squibb, MSD Oncology, Pfizer, Janssen-Cilag, AstraZeneca, Amgen<bold>Travel, Accommodations, Expenses:</bold> Bristol Myers Squibb, Pfizer, Janssen-Cilag, Astellas Pharma, MSD, Ipsen <bold>Phillip Palmbos</bold><bold>Research Funding:</bold> Roche, Immunomedics <bold>Christos Kyriakopoulos</bold><bold>Consulting or Advisory Role:</bold> Exelixis, Sanofi, AVEO, EMD Serono, Janssen Oncology<bold>Research Funding:</bold> Sanofi <bold>Damien Pouessel</bold><bold>Honoraria:</bold> Ipsen, Janssen Oncology, Bristol Myers Squibb, AstraZeneca, Merck, Astellas Pharma<bold>Consulting or Advisory Role:</bold> Astellas Pharma, AstraZeneca, Janssen Oncology, Pfizer, Sanofi<bold>Research Funding:</bold> Incyte, Merck Sharp &amp; Dohme, Roche, Bristol Myers Squibb, AstraZeneca, Janssen Oncology, Seattle Genetics<bold>Travel, Accommodations, Expenses:</bold> Janssen Oncology, AstraZeneca, Pfizer <bold>Cora Sternberg</bold><bold>Consulting or Advisory Role:</bold> BMS, MSD, Pfizer, Roche-Genentech, Incyte, AstraZeneca, Merck, Medscape, UroToday, Astellas Pharma, Sanofi-Genzyme, Immunomedics, now Gilead, Foundation Medicine, CCO Clinical, Janssen, NCI<bold>Research Funding:</bold> Pfizer, MSD, Astellas, BMS, Immunomedics, now Gilead, Arvinas, Mirati <bold>Quan Hong</bold><bold>Employment:</bold> Immunomedics, Gilead Sciences<bold>Leadership:</bold> Immunomedics<bold>Stock and Other Ownership Interests:</bold> Immunomedics <bold>Trishna Goswami</bold><bold>Employment:</bold> Immunomedics/Gilead<bold>Leadership:</bold> Immunomedics/Gilead<bold>Stock and Other Ownership Interests:</bold> Immunomedics/Gilead<bold>Patents, Royalties, Other Intellectual Property:</bold> Patents around combinations with Trodelvy<bold>Travel, Accommodations, Expenses:</bold> Immunomedics/Gilead <bold>Loretta Itri</bold><bold>Employment:</bold> Immunomedics/Gilead<bold>Leadership:</bold> Immunomedics/Gilead<bold>Stock and Other Ownership Interests:</bold> Immunomedics<bold>Consulting or Advisory Role:</bold> Immunomedics<bold>Travel, Accommodations, Expenses:</bold> Immunomedics <bold>Petros Grivas</bold><bold>Consulting or Advisory Role:</bold> Merck, Bristol Myers Squibb, AstraZeneca, Clovis Oncology, EMD Serono, Seattle Genetics, Foundation Medicine, Pfizer, Janssen, Bayer, Genzyme, Mirati Therapeutics, Exelixis, Roche, GlaxoSmithKline, Genentech, Immunomedics, Dyania Health, Infinity Pharmaceuticals, QED Therapeutics, 4D Pharma PLC<bold>Research Funding:</bold> Pfizer, Clovis Oncology, Bavarian Nordic, Immunomedics, Bristol Myers Squibb, Debiopharm Group, Merck, QED Therapeutics, Kure It Cancer Research, GlaxoSmithKline, Mirati TherapeuticsNo other potential conflicts of interest were reported.</p>
</div>
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<div class="figures" id="figures">
<h2 class="title">
Figures
</h2>
<div class="figures-list" id="slides-container"
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data-image-height="631"
data-image-alt="FIG 1."
data-pmc-id="PMC8315301"
data-figure-id="fig1">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-0"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf1/8315301/345ecdfbc40b/jco-39-2474-g001.gif"
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<strong class="figure-label">
<p> FIG 1. </p>
</strong>
<div class="figure-caption-contents"><p> CONSORT diagram. CPI, checkpoint inhibitor;… </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. CPI, checkpoint inhibitor; IV, intravenous; mUC, metastatic urothelial cancer. </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. CPI, checkpoint inhibitor; IV, intravenous; mUC, metastatic urothelial cancer.</div>
</figcaption>
</figure>
<figure class="figure-item "
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<a class="figure-link"
href="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf1/8315301/e7e8162add32/jco-39-2474-g004.jpg"
itemprop="contentUrl"
aria-describedby="figure-caption-1"
role="button"
data-image-width="708"
data-image-height="1097"
data-image-alt="FIG 2."
data-pmc-id="PMC8315301"
data-figure-id="fig2">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-1"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf1/8315301/eb622fefe81d/jco-39-2474-g004.gif"
alt="FIG 2." />
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<div class="caption-wrap">
<strong class="figure-label">
<p> FIG 2. </p>
</strong>
<div class="figure-caption-contents"><p> Tumor response to sacituzumab govitecan.… </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> Tumor response to sacituzumab govitecan. (A) Waterfall plot showing best percent change from… </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">Tumor response to sacituzumab govitecan. (A) Waterfall plot showing best percent change from baseline in the sum of the diameters of the target lesions (longest for non-nodal and short axis for nodal lesions) in 94 patients (excludes 19 patients; 15 patients did not have post-baseline radiologic assessments and four patients lacked or had unevaluable target lesions at baseline or post-baseline). The dashed lines at +20% and 30% indicate thresholds for PD and partial response, respectively, according to RECIST v1.1. Target lesions were reduced in 77% of patients (72 of 94) with at least 1 post-baseline target lesion measurement. (B) Spider plot of tumor response by week. (C) Swimmer plot of response and duration. PD, progressive disease.</div>
</figcaption>
</figure>
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data-image-width="598"
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data-image-alt="FIG 3."
data-pmc-id="PMC8315301"
data-figure-id="fig3">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-2"
src="https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2cf1/8315301/ae40eaa56a25/jco-39-2474-g005.gif"
alt="FIG 3." />
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<strong class="figure-label">
<p> FIG 3. </p>
</strong>
<div class="figure-caption-contents"><p> Kaplan-Meier analysis of (A) PFS,… </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> Kaplan-Meier analysis of (A) PFS, (B) OS, and (C) DOR. DOR, duration of… </p></div>
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<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">Kaplan-Meier analysis of (A) PFS, (B) OS, and (C) DOR. DOR, duration of response; OS, overall survival; PFS, progression-free survival.</div>
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itemprop="contentUrl"
aria-describedby="figure-caption-3"
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data-image-width="690"
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data-image-alt="FIG A1."
data-pmc-id="PMC8315301"
data-figure-id="figA1">
<img class="figure-thumb" itemprop="thumbnail"
id="article-image-3"
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<strong class="figure-label">
<p> FIG A1. </p>
</strong>
<div class="figure-caption-contents"><p> TROPHY-U-01 study design. EudraCT Number:… </p></div>
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<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> TROPHY-U-01 study design. EudraCT Number: 2018-001167-23; ClinicalTrials.gov identifier: <ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/ct2/show/NCT03547973" xmlns:xlink="http://www.w3.org/1999/xlink"> NCT03547973 </ext-link> ; IMMU-132-06 study. CPI,… </p></div>
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FIG A1.
</strong>
<div class="figure-caption-contents">TROPHY-U-01 study design. EudraCT Number: 2018-001167-23; ClinicalTrials.gov identifier: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/ct2/show/NCT03547973">NCT03547973</ext-link>; IMMU-132-06 study. CPI, checkpoint inhibitor; DOR, duration of response; mUC, metastatic urothelial cancer; ORR, objective response rate; OS, overall survival; PD-1, programmed death-1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; SG, sacituzumab govitecan.</div>
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<p> FIG A2. </p>
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<div class="figure-caption-contents"><p> Forest plot showing ORR in… </p></div>
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<p> FIG A2. </p>
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<div class="figure-caption-contents"><p> Forest plot showing ORR in different subgroups. Horizontal line represents CI. ECOG, Eastern… </p></div>
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FIG A2.
</strong>
<div class="figure-caption-contents">Forest plot showing ORR in different subgroups. Horizontal line represents CI. ECOG, Eastern Cooperative Oncology Group; NA, not available; ORR, objective response rate.</div>
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Sacituzumab govitecan is safe and effective.
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ADC sacituzumab govitecan shows efficacy and safety.
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Associated data
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