{"id":28485,"date":"2022-11-25T08:00:00","date_gmt":"2022-11-25T08:00:00","guid":{"rendered":"http:\/\/345f7122807abdfe0c9092099e2f801a"},"modified":"2024-11-03T15:13:11","modified_gmt":"2024-11-03T15:13:11","slug":"fda-approves-cemiplimab-rwlc-in-combination-with-platinum-based-chemotherapy-for-advanced-nsclc","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-cemiplimab-rwlc-in-combination-with-platinum-based-chemotherapy-for-advanced-nsclc\/","title":{"rendered":"FDA Approves Cemiplimab-rwlc in Combination with Platinum-Based Chemotherapy for Advanced NSCLC"},"content":{"rendered":"<p>On 8 November 2022, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no <em>EGFR<\/em>, <em>ALK<\/em>, or <em>ROS1<\/em> aberrations.<\/p>\n<p>Efficacy was evaluated in Study 16113 (NCT03409614), a randomised, multicentre, multinational, double-blind, active-controlled study in 466 patients with advanced NSCLC who had not received prior systemic treatment. Patients were randomised (2:1) to either cemiplimab-rwlc plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by cemiplimab-rwlc and maintenance chemotherapy or placebo plus platinum-based chemotherapy every 3 weeks for 4 cycles followed by placebo and maintenance chemotherapy.<\/p>\n<p>The main efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression-free survival (PFS) and overall response rate (ORR) as assessed by blinded independent central review (BICR).<\/p>\n<p>Cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to placebo plus chemotherapy (hazard ratio [HR] of 0.71, 95% confidence interval [CI] 0.53, 0.93; two-sided p-value = 0.0140). Median OS was 21.9 months (95% CI 15.5, not evaluable) in the cemiplimab-rwlc plus chemotherapy arm and 13.0 months (95% CI 11.9, 16.1) in the placebo plus chemotherapy arm. Median PFS per BICR was 8.2 months (95% CI 6.4, 9.3) in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months (95% CI 4.3, 6.2) in the placebo plus chemotherapy arm (HR 0.56, 95% CI 0.44, 0.70; p &lt; 0.0001). Confirmed ORR per BICR was 43% (95% CI 38, 49) and 23% (95% CI 16, 30) in the respective treatments.<\/p>\n<p>The most common (\u226515%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.<\/p>\n<p>The recommended cemiplimab-rwlc dose is 350 mg i.v. every 3 weeks. Refer to the prescribing information for the agents administered in combination with cemiplimab-rwlc for recommended dosing information, as appropriate.<\/p>\n<p>Full prescribing information for Libtayo is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761097s014lbl.pdf\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">here<\/a>.<\/p>\n<p>This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n<p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n<p>For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/oncology-center-excellence\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Oncology Center of Excellence<\/a>&nbsp;<a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-facilitate\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"external-link\">Project Facilitate<\/a>.<\/p>\n<p><a href=\"https:\/\/www.esmo.org\/oncology-news\/fda-approves-cemiplimab-rwlc-in-combination-with-platinum-based-chemotherapy-for-advanced-nsclc\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 8 November 2022, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. Efficacy was evaluated in Study 16113 (NCT03409614), a randomised, multicentre, multinational, double-blind, active-controlled study in 466 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-28485","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28485","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=28485"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28485\/revisions"}],"predecessor-version":[{"id":44794,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/28485\/revisions\/44794"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=28485"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=28485"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=28485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}