{"id":493611,"date":"2024-01-22T12:20:00","date_gmt":"2024-01-22T17:20:00","guid":{"rendered":"https:\/\/platohealth.ai\/gilead-adc-medicine-misses-goal-in-closely-watched-lung-cancer-study\/"},"modified":"2024-01-22T17:31:08","modified_gmt":"2024-01-22T22:31:08","slug":"gilead-adc-medicine-misses-goal-in-closely-watched-lung-cancer-study","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/gilead-adc-medicine-misses-goal-in-closely-watched-lung-cancer-study\/","title":{"rendered":"Gilead ADC medicine misses goal in closely watched lung cancer study","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/gilead-adc-medicine-misses-goal-in-closely-watched-lung-cancer-study.jpg\" class=\"ff-og-image-inserted\"><\/div>\n<h3>Dive Brief:<\/h3>\n<ul>\n<li>Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial in lung cancer, failing to help keep patients alive longer than chemotherapy after their disease had progressed on earlier lines of treatment.<\/li>\n<li>In a statement, Gilead said Trodelvy-treated patients had a \u201cnumerical improvement\u201d in survival that didn\u2019t reach statistical significance. A subgroup of patients who didn\u2019t respond to a cancer immunotherapy had a three-month improvement in survival, but that analysis wasn\u2019t part of a formal statistical test.<\/li>\n<li>The setback could separate Gilead\u2019s medicine from a rival drug developed by AstraZeneca and Daiichi Sankyo known as datopotamab deruxtecan. That medicine <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/dailyreporter.esmo.org\/esmo-congress-2023\/non-small-cell-lung-cancer\/datopotamab-deruxtecan-met-the-pfs-endpoint-in-previously-treated-nsclc\">reduced the risk of disease progression or death<\/a> by 25% in a similar trial, but hasn\u2019t yet been proven to extend survival.<\/li>\n<\/ul>\n<h3>Dive Insight:<\/h3>\n<p>Trodelvy is one of a wave of \u201cantibody-drug conjugates\u201d that have been approved by regulators in recent years. These drugs combine the targeting capabilities of antibodies with a tumor-killing chemical, a profile that\u2019s meant to be more potent and safer than older chemotherapies. They\u2019re now coveted by large pharmaceutical companies.<\/p>\n<p>Trodelvy is an example of such interest, as its potential led Gilead to pay $21 billion for its maker, Immunomedics, in 2020. While the drug has been approved for certain breast and bladder cancers, it isn\u2019t yet a top seller. Its progress has also been overshadowed by other ADCs, most notably AstraZeneca and Daiichi\u2019s fast-selling Enhertu.<\/p>\n<p>Trodelvy is one of a few ADCs, like datopotamab deruxtecan, that target TROP2, a protein overexpressed in all types of lung cancer. The company was trying to prove Trodelvy could replace chemotherapy in one of the most common tumor types. While the outlook for people with lung cancer has improved with the arrival of immunotherapies like Merck &amp; Co.\u2019s Keytruda, better treatments for those who progress or don\u2019t respond are still needed.<\/p>\n<p>In Gilead\u2019s study, EVOKE-01, the company tested Trodelvy in patients who had progressed following treatment with a platinum-based chemotherapy and an immunotherapy. Half of the 603 patients were given Trodelvy and the other half received docetaxel. Trial investigators measured whether Trodelvy could help patients live longer.<\/p>\n<p>Heading into the study results, analysts had lowered expectations for Trodelvy, as datopotamab deruxtecan didn\u2019t produce a statistically significant survival benefit in a similar trial. The drug\u2019s benefit on tumor progression was modest, too.<\/p>\n<p>Differences in the drugs and Gilead\u2019s trial design led some industry watchers to suggest Trodelvy could produce a better result. Nonetheless, because datopotomab deruxtecan struggled to show a benefit, Trodelvy\u2019s failure is \u201cnot totally surprising,\u201d Jefferies analyst Michael Yee wrote in a note to clients.<\/p>\n<p>Yee noted how the claimed survival benefit in those who hadn\u2019t responded to Keytruda or similar immunotherapies was an \u201cinteresting and promising finding.\u201d However, he wrote, \u201cWe assume [Gilead] will not be able to file this package to FDA overall.\u201d<\/p>\n<p>Gilead reported Trodelvy sales of $764 million through the first nine months of 2023, representing around one-third of the company\u2019s oncology sales. The cell therapy Yescarta is Gilead\u2019s top-selling cancer medicine, recording $1.1 billion through the first nine months of 2023.<\/p>\n<p>Gilead shares fell as much as 11% in morning trading.<\/p>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. Empower Yourself. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platodata.network\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoaistream\">PlatoAiStream. Web3 Intelligence. Knowledge Amplified. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoaistream.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoesg\">PlatoESG. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/carbon\/\">Carbon,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/cleantech\/\">CleanTech,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/energy\/\">Energy,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/environment\/\">Environment,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/solar\/\">Solar,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/waste-management\/\">Waste Management.<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platohealth\">PlatoHealth. Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.biopharmadive.com\/news\/gilead-trodelvy-lung-cancer-study-results-evoke\/705165\/\">https:\/\/www.biopharmadive.com\/news\/gilead-trodelvy-lung-cancer-study-results-evoke\/705165\/<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>Dive Brief: Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial in lung cancer, failing to help keep patients alive longer than chemotherapy after their disease had progressed on earlier lines of treatment. In a statement, Gilead said Trodelvy-treated patients had a \u201cnumerical improvement\u201d in survival [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":493614,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[50],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493611"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=493611"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493611\/revisions"}],"predecessor-version":[{"id":493613,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493611\/revisions\/493613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/493614"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=493611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=493611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=493611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}