Major Victory For Genmab As Epkinly Receives FDA Approval For Type Of Pretreated Blood Cancer

Benzinga11-19

The U.S. Food and Drug Administration approved Genmab A/S (NASDAQ:GMAB) Epkinly (epcoritamab-bysp) on Tuesday with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The ...

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Clinical trial data show superior results.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4201":"综合性石油与天然气企业","GMAB":"Genmab A/S","BK4211":"区域性银行","ORR":"Militia Long/Short Equity ETF","BK4139":"生物科技","BK4195":"互助储蓄与抵押信贷金融服务","EC":"哥伦比亚国家石油","CR":"crane","BK4161":"工业机械","PFS":"Provident Financial Services Inc"},"translate_title":"Genmab取得重大胜利，Epkinly获得FDA批准治疗一种预处理血癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"EC":1,"PFS":1,"GMAB":1,"ORR":1,"CR":1},"content_text":"The U.S. Food and Drug Administration approved Genmab A/S (NASDAQ:GMAB) Epkinly (epcoritamab-bysp) on Tuesday with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL).\nThe FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy.\nEpcoritamab-bysp was granted accelerated approval for this indication in 2024.\nApproval of epcoritamab-bysp with lenalidomide and rituximab (R2) was based on the EPCORE FL-1 study, a randomized, open-label trial that enrolled 488 patients with relapsed or refractory FL.\nAlso Read: Genmab Makes $8 Billion Bet On Merus With Potential Cancer Breakthrough\nPatients were randomized (1:1) to receive epcoritamab-bysp plus R2 or R2 alone. Patients had a median of one prior line of systemic therapy; 24% and 17% had two and three or more prior lines, respectively.\nEfficacy was established based on progression-free survival (PFS) and overall response rate (ORR).\nThe study demonstrated superiority of PFS and ORR in the epcoritamab-bysp arm. The PFS hazard ratio was 0.21.\nThe median PFS was not reached (NR) in the epcoritamab-bysp arm and was 11.2 months in the control arm. The ORR was 89% in the epcoritamab-bysp arm and 74% in the control arm.\nIn October, Genmab shared updated data from cohort B2 of the Phase 1/2 RAINFOL-01 trial evaluating rinatabart sesutecan (Rina-S).\nThe study showed that at a median study follow-up of one year, treatment with Rina-S 100 mg/m² every three weeks (Q3W) resulted in a 50% confirmed objective response rate (ORR), including two complete responses (CR), in heavily pretreated patients with advanced endometrial cancer (EC) who had progressed following platinum-based chemotherapy and an immune checkpoint inhibitor.\nAdditionally, at a median study follow-up of one year, 63.6% of responders (including CRs) in the 100 mg/m² cohort maintained their responses and remain on treatment. The responses were observed regardless of FRα expression levels.\nGMAB Price Action: Genmab stock is down 1.55% at $29.95 at publication on Tuesday.\nRead Next:\nPhoto: Shutterstock","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.10","shortVersion":"4.35.10","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2584957554","isCrawlerRequest":true}