{"id":333206,"date":"2020-10-09T14:00:00","date_gmt":"2020-10-09T12:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/regulatory-extension-for-durvalumab\/"},"modified":"2020-10-09T14:00:00","modified_gmt":"2020-10-09T12:00:00","slug":"regulatory-extension-for-durvalumab","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/regulatory-extension-for-durvalumab\/","title":{"rendered":"Regulatory extension for durvalumab"},"content":{"rendered":"

Durvalumab was approved EU-wide in combination with chemotherapy of etoposide plus either cisplatin or carboplatin followed by durvalumab maintenance therapy for the first-line treatment of adults with advanced-stage small cell lung cancer (SCLC) (extensive disease, ED).<\/strong><\/p>\n

<\/p>\n

The European Commission’s approval extension for durvalumab for the first-line treatment of ED-SCLC in combination with chemotherapy is based on the positive results of the Phase III CASPIAN study, which demonstrated a statistically significant and clinically meaningful survival benefit for durvalumab plus chemotherapy in the first-line treatment of patients with ED-SCLC. In addition to a significant and sustained benefit in overall survival (OS), a proven benefit in progression-free survival (PFS) over 24 months was documented for the first time in maintenance.<\/p>\n

Durvalumab (IMFINZI\u00ae<\/sup>) is a human monoclonal antibody directed against PD-L1 that blocks the interaction of PD-L1 with PD-1 and CD80 on T cells. As a result, it counteracts the immunosuppressive effect of tumor cells, enabling enhanced activation of T cells and the associated immune response. “The approval of durvalumab provides physicians with an important new therapeutic option that offers a significant overall survival benefit with a well-tolerated treatment,” said Luis Paz-Ares MD, Ph.D., Chairman, Department of Medical Oncology, University Hospital Doce de Octubre, Madrid, and Principal Investigator of CASPIAN.<\/p>\n

Significant reduction in mortality risk<\/h2>\n

The CASPIAN trial met its primary endpoint, OS, in June 2019 and documented a 27% reduction in risk of death (hazard ratio [HR] 0.73, 95% confidence interval [KI] 0.59-0.91; p=0.0047). It also demonstrated an increased confirmed objective response rate for durvalumab plus chemotherapy (68% versus 58% for chemotherapy alone). Durvalumab in addition to chemotherapy also delayed the time to worsening of disease symptoms.<\/p>\n

A follow-up analysis presented at ASCO 2020 showed sustained efficacy for durvalumab plus chemotherapy after a median follow-up of more than two years (OS: HR 0.75; 95% CI 0.62-0.91; nominal p=0.0032), with a median OS of 12.9 months versus 10.5 months for chemotherapy alone.<\/p>\n

SCLC is a highly aggressive, fast-growing form of lung cancer that progresses rapidly despite an initial good response to chemotherapy, leading to early progression. The CASPIAN trial used a fixed dose of durvalumab (1500 mg) given every three weeks during induction in combination with chemotherapy for four cycles and every four weeks thereafter until disease progression as maintenance therapy.<\/p>\n

Source: AstraZeneca<\/em><\/p>\n

 <\/p>\n

InFo PNEUMOLOGY & ALLERGOLOGY 2020; 2(3): 33.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Durvalumab was approved EU-wide in combination with chemotherapy of etoposide plus either cisplatin or carboplatin followed by durvalumab maintenance therapy for the first-line treatment of adults with advanced-stage small cell…<\/p>\n","protected":false},"author":7,"featured_media":99870,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Small cell lung carcinoma","footnotes":""},"category":[11530,11370,11455,11548,11503],"tags":[23691,23700,18855],"powerkit_post_featured":[],"class_list":["post-333206","post","type-post","status-publish","format-standard","has-post-thumbnail","category-market-medicine","category-oncology","category-pneumology","category-rx-en","category-studies","tag-caspian-en","tag-durvalumab-en","tag-lung-cancer-en-2","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-07-07 03:48:46","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":333219,"slug":"extension-de-lautorisation-de-mise-sur-le-marche-de-durvalumab","post_title":"Extension de l'autorisation de mise sur le march\u00e9 de Durvalumab","href":"https:\/\/medizinonline.com\/fr\/extension-de-lautorisation-de-mise-sur-le-marche-de-durvalumab\/"},"it_IT":{"locale":"it_IT","id":333227,"slug":"estensione-normativa-per-durvalumab","post_title":"Estensione normativa per durvalumab","href":"https:\/\/medizinonline.com\/it\/estensione-normativa-per-durvalumab\/"},"pt_PT":{"locale":"pt_PT","id":333235,"slug":"extensao-regulamentar-para-durvalumab","post_title":"Extens\u00e3o regulamentar para durvalumab","href":"https:\/\/medizinonline.com\/pt-pt\/extensao-regulamentar-para-durvalumab\/"},"es_ES":{"locale":"es_ES","id":333244,"slug":"prorroga-reglamentaria-para-el-durvalumab","post_title":"Pr\u00f3rroga reglamentaria para el durvalumab","href":"https:\/\/medizinonline.com\/es\/prorroga-reglamentaria-para-el-durvalumab\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/333206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=333206"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/333206\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/99870"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=333206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=333206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=333206"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=333206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}