{"id":67764,"date":"2026-06-09T21:46:46","date_gmt":"2026-06-09T13:46:46","guid":{"rendered":"https:\/\/flcube.com\/?p=67764"},"modified":"2026-06-09T21:46:49","modified_gmt":"2026-06-09T13:46:49","slug":"msd-and-gilead-discontinue-phase-3-keynote-d46-evoke-03-study-of-trodelvy-keytruda-combination-in-first-line-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67764","title":{"rendered":"MSD and Gilead Discontinue Phase 3 KEYNOTE-D46\/EVOKE-03 Study of Trodelvy-KEYTRUDA Combination in First-Line NSCLC"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Merck &amp; Co., Inc.<\/strong> (MSD; <a href=\"https:\/\/www.google.com\/finance\/quote\/MRK:NYSE\">NYSE: MRK<\/a>) and <strong>Gilead Sciences, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/GILD:NASDAQ\">NASDAQ: GILD<\/a>) announced today the discontinuation of the Phase 3 <strong>KEYNOTE-D46\/EVOKE-03<\/strong> clinical trial evaluating the combination of <strong>Trodelvy<\/strong> (sacituzumab govitecan) and <strong>KEYTRUDA<\/strong> (pembrolizumab) versus KEYTRUDA monotherapy in previously untreated metastatic non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) \u226550%.<\/p>\n\n\n\n<h2 id=\"h-clinical-trial-assessment\" class=\"wp-block-heading\">Clinical Trial Assessment<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Outcome<\/th><\/tr><\/thead><tbody><tr><td><strong>Study Design<\/strong><\/td><td>Phase 3, randomized, KEYNOTE-D46\/EVOKE-03<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>Treatment-na\u00efve metastatic NSCLC with PD-L1 TPS \u226550%<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Progression-free survival (PFS)<\/td><\/tr><tr><td><strong>Secondary Endpoint<\/strong><\/td><td>Overall survival (OS)<\/td><\/tr><tr><td><strong>PFS Result<\/strong><\/td><td>Numerical improvement observed, but not statistically significant<\/td><\/tr><tr><td><strong>OS Projection<\/strong><\/td><td>Unlikely to achieve statistical significance at final analysis<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Consistent with known profiles of individual agents; no new safety signals<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-decision-framework\" class=\"wp-block-heading\">Decision Framework<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Recommendation Source<\/strong>: External Data Monitoring Committee (eDMC)<\/li>\n\n\n\n<li><strong>Data Reviewed<\/strong>: Pre-specified final analysis of PFS and interim analysis of OS<\/li>\n\n\n\n<li><strong>Rationale<\/strong>: Low probability of achieving statistically significant OS benefit at planned final analysis<\/li>\n\n\n\n<li><strong>Patient Impact<\/strong>: Participants will be notified and transitioned to appropriate alternative treatments per investigator discretion<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-implications\" class=\"wp-block-heading\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Reprioritization<\/strong>: Both companies will redirect resources to other high-potential combination studies<\/li>\n\n\n\n<li><strong>Trodelvy Development<\/strong>: Gilead continues to advance Trodelvy in other indications including HR+\/HER2- breast cancer and urothelial cancer<\/li>\n\n\n\n<li><strong>KEYTRUDA Combinations<\/strong>: Merck maintains active development of KEYTRUDA with multiple partners across diverse tumor types<\/li>\n\n\n\n<li><strong>NSCLC Landscape<\/strong>: Monotherapy KEYTRUDA remains standard of care for first-line treatment in PD-L1 high (TPS \u226550%) metastatic NSCLC<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-context\" class=\"wp-block-heading\">Market Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NSCLC Treatment Paradigm<\/strong>: PD-L1 high metastatic NSCLC represents approximately 30% of all NSCLC cases<\/li>\n\n\n\n<li><strong>Combination Therapy Trends<\/strong>: Despite strong rationale for ADC-immunotherapy combinations, clinical success has been limited by toxicity and efficacy challenges<\/li>\n\n\n\n<li><strong>Competitive Environment<\/strong>: Multiple pharmaceutical companies continue to explore different ADC-IO combinations in various tumor types<\/li>\n\n\n\n<li><strong>Investor Impact<\/strong>: The discontinuation is not expected to significantly impact near-term revenue projections for either company<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-forward-looking-statements\" class=\"wp-block-heading\">Forward-Looking Statements<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This brief contains forward-looking statements regarding clinical development decisions, pipeline priorities, and strategic implications. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, competitive dynamics, and market conditions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Merck &amp; Co., Inc. (MSD; NYSE: MRK) and Gilead Sciences, Inc. (NASDAQ: GILD) announced today&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,17,29,120,2675,176,1025,903,18],"class_list":["post-67764","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-results","tag-combination-therapy","tag-merck","tag-merck-sharp-dohme","tag-msd","tag-nasdaq-gild","tag-nyse-mrk","tag-pd-1-l1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MSD and Gilead Discontinue Phase 3 KEYNOTE-D46\/EVOKE-03 Study of Trodelvy-KEYTRUDA Combination in First-Line NSCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Merck &amp; Co., Inc. (MSD; NYSE: MRK) and Gilead Sciences, Inc. (NASDAQ: GILD) announced today the discontinuation of the Phase 3 KEYNOTE-D46\/EVOKE-03 clinical trial evaluating the combination of Trodelvy (sacituzumab govitecan) and KEYTRUDA (pembrolizumab) versus KEYTRUDA monotherapy in previously untreated metastatic non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) \u226550%.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=67764\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MSD and Gilead Discontinue Phase 3 KEYNOTE-D46\/EVOKE-03 Study of Trodelvy-KEYTRUDA Combination in First-Line NSCLC\" \/>\n<meta property=\"og:description\" content=\"Merck &amp; Co., Inc. (MSD; NYSE: MRK) and Gilead Sciences, Inc. (NASDAQ: GILD) announced today the discontinuation of the Phase 3 KEYNOTE-D46\/EVOKE-03 clinical trial evaluating the combination of Trodelvy (sacituzumab govitecan) and KEYTRUDA (pembrolizumab) versus KEYTRUDA monotherapy in previously untreated metastatic non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) \u226550%.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=67764\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-09T13:46:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-09T13:46:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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