{"id":30965,"date":"2025-03-31T16:16:23","date_gmt":"2025-03-31T08:16:23","guid":{"rendered":"https:\/\/flcube.com\/?p=30965"},"modified":"2025-03-31T16:16:25","modified_gmt":"2025-03-31T08:16:25","slug":"bmss-opdivo-yervoy-combo-approved-by-nmpa-for-first-line-hcc-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30965","title":{"rendered":"BMS&#8217;s Opdivo\/Yervoy Combo Approved by NMPA for First-Line HCC Treatment"},"content":{"rendered":"\n<p>Bristol-Myers Squibb (BMS, <a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE: BMY<\/a>) announced that it has received approval from China&#8217;s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo\/Yervoy combination the first and currently only immunotherapy regimen approved for first-line HCC treatment in China.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>The approval is supported by results from the Phase III CheckMate-9DW trial, which demonstrated superior efficacy of the Opdivo\/Yervoy combination compared to previous standard treatments (lenvatinib or sorafenib). Key findings include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Median Overall Survival (OS):<\/strong> 23.7 months for the combination vs. 20.6 months for the control group, representing a 21% reduction in the risk of death (P=0.018).<\/li>\n\n\n\n<li><strong>Objective Response Rate (ORR):<\/strong> 36% for the combination vs. 13% for the control group.<\/li>\n\n\n\n<li><strong>Median Duration of Response (mDOR):<\/strong> 30.4 months for the combination, more than double that of the control group.<\/li>\n<\/ul>\n\n\n\n<p><strong>Safety Profile<\/strong><br>The combination therapy demonstrated an overall safety and tolerability profile consistent with previous findings, with no new safety signals identified. The incidence of grade 3\/4 treatment-related adverse events was 41% in the combination group, comparable to 42% in the control group.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China&#8217;s National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":30966,"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":[429,428,16,29,742,849,18,15],"class_list":["post-30965","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-combination-therapy","tag-i-o-targets-2","tag-nyse-bmy","tag-pd-1-l1","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BMS&#039;s Opdivo\/Yervoy Combo Approved by NMPA for First-Line HCC Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China&#039;s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo\/Yervoy combination the first and currently only immunotherapy regimen approved for first-line HCC treatment in China.\" \/>\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=30965\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BMS&#039;s Opdivo\/Yervoy Combo Approved by NMPA for First-Line HCC Treatment\" \/>\n<meta property=\"og:description\" content=\"Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China&#039;s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). 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