Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC, Supporting Planned New Drug Application Submission in the Fourth Quarter of 2024

Business Wire09-14

Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were ...

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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nPositive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC, Supporting Planned New Drug Application Submission in the Fourth Quarter of 2024\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-14 15:05 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/positive-pooled-data-nuvation-bio-070500253.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were ...</p>\n\n<a href=\"https://finance.yahoo.com/news/positive-pooled-data-nuvation-bio-070500253.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"AEIS","symbol_name":"先进能源工业公司","start_time":0,"source_url":"https://finance.yahoo.com/news/positive-pooled-data-nuvation-bio-070500253.html","article_id":"2467660290","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/5ZQt_l8g5mvtOjJxShyKAw--~B/aD0yNjg7dz04NjQ7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/5107ae850ae34193526f01e722ad0708"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2467660290","pubTimestamp":1726297500,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive  non-small cell lung cancer  who were tyrosine kinase inhibitor -nave and 56% of those who were TKI-pretreated in the study. Taletrectinib demonstrated durable responses and prolonged progression-free survival  with long-term follow up; median duration of response  and median PFS in TKI-nave patients were 44 months and 46 months, respectively. Taletrectinib demonstrated a favorable safety and tolerability profile, including low incidence of neurologic treatment-emergent adverse events  and low rate of treatment discontinuation. Nuvation Bio plans to submit a New Drug Application  for taletrectinib to the U.S. Food and Drug Administration  in the fourth quarter of 2024. The pooled efficacy and safety data from the TRUST-I and TRUST-II studies presented at ESMO are as of June 7, 2024; both studies remain ongoing. The ESMO data set includes 337 patients with advanced ROS1+ NSCLC who received 600mg of taletr","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"AEIS":"先进能源工业公司","BK4007":"制药","DDC":"日日煮","BK4211":"区域性银行","IE00B19Z4B17.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) ACC","BK4212":"包装食品与肉类","NUVB":"Nuvation Bio, Inc.","IE00B66KJ199.SGD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY  \" A\" (SGD) ACC","BK4195":"互助储蓄与抵押信贷金融服务","IE0031619046.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) INC","BK4157":"电子设备和仪器","PFS":"Provident Financial Services Inc","IE00B7SZL793.SGD":"Legg Mason Royce - US Small Cap Opportunity A Acc SGD-H"},"translate_title":"Nuvation Bio TRUST-I和TRUST-II研究的积极汇总数据凸显了Taletrectinib对晚期ROS1阳性非小细胞肺癌患者的同类最佳潜力，支持了计划于2024年第四季度提交的新药申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AEIS":1,"DDC":1,"PFS":1,"NUVB":0.9},"content_text":"Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study\nTaletrectinib demonstrated durable responses and prolonged progression-free survival (PFS) with long-term follow up; median duration of response (DOR) and median PFS in TKI-naïve patients were 44 months and 46 months, respectively\nTaletrectinib demonstrated a favorable safety and tolerability profile, including low incidence of neurologic treatment-emergent adverse events (TEAEs) and low rate of treatment discontinuation\nNuvation Bio plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024\nNEW YORK, September 14, 2024--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI. The findings will be highlighted in a poster presentation on September 14, 2024, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.\nMaurice Perol, M.D., TRUST-II study investigator and Head of Thoracic Oncology at Léon Bérard Cancer Center, commented on the results: \"The unmet need for more effective and tolerable treatments for patients with advanced ROS1-positive NSCLC remains critical. The pooled analysis from the TRUST-I and TRUST-II studies reinforces taletrectinib’s potential to offer clinically meaningful advancements in efficacy combined with a favorable safety profile, including reported median duration of response of 44 months and progression-free survival of 46 months in patients who were TKI-naïve.\"\n\"We are excited to present compelling pooled data from the TRUST-I and TRUST-II studies at ESMO, which highlight taletrectinib’s durable response, prolonged disease control, and favorable safety profile. We believe these results position taletrectinib as a potential best-in-class treatment option for people living with advanced ROS1-positive NSCLC,\" said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. \"These pivotal data will support our planned NDA submission in the fourth quarter of 2024 and, assuming regulatory approval, will enable us to launch taletrectinib in the U.S. in 2025. We are committed to making a positive impact on the lung cancer community and look forward to sharing updates as we continue toward becoming a commercial stage organization.\"\nSummary of Pivotal Pooled Data\nThe pooled efficacy and safety data from the TRUST-I and TRUST-II studies presented at ESMO are as of June 7, 2024; both studies remain ongoing. The ESMO data set includes 337 patients with advanced ROS1+ NSCLC who received 600mg of taletrectinib orally once daily in 21-day cycles.\nThe primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, DOR, PFS, and safety.\nSignificant Tumor Shrinkage and Durability\nThe pooled efficacy analyses included 160 patients with advanced ROS1+ NSCLC who had not previously been treated with a ROS1 TKI (TKI-naïve) and 113 patients who had previously been treated with crizotinib or entrectinib (TKI-pretreated).\nAmong these two populations, 94% of patients had stage IV NSCLC. In addition, 20% of TKI-naïve and 37% of TKI-pretreated patients received prior chemotherapy, while 23% of TKI-naïve and 49% of TKI-pretreated patients had brain metastases at baseline.\nThe efficacy results, independently assessed by an IRC, showed:\nIn TKI-naïve patients (n=160):\n\nTumors shrank in 89% of taletrectinib-treated patients (cORR).\nMeasurable brain metastases shrank in 77% (13/17) of taletrectinib-treated patients (intracranial cORR).\nAfter median follow-up of 21 months, the median DOR and the median PFS were 44 months and 46 months, respectively.\n\nIn TKI-pretreated patients (n=113):\n\nTumors shrank in 56% of taletrectinib-treated patients (cORR).\nMeasurable brain metastases shrank in 66% (21/32) of taletrectinib-treated patients (intracranial cORR).\nTumors shrank in 62% (8/13) of taletrectinib-treated patients with G2032R mutations (cORR).\nAfter median follow-up of 21 months, the median DOR and the median PFS were 17 months and 10 months, respectively.\n\nFavorable and Consistent Safety Profile Across Studies\nThe pooled safety analysis included 337 patients with advanced ROS1+ NSCLC. The results demonstrated a favorable safety and tolerability profile, with a low incidence and a limited spectrum of neurologic TEAEs and a low rate of treatment discontinuation.\nThe most frequent TEAEs were increased aspartate aminotransferase (72%; 8% ≥ Grade 3), alanine aminotransferase (68%; 10% ≥ Grade 3), diarrhea (63%; 2% ≥ Grade 3), and nausea (47%; 2% ≥ Grade 3).\nThe incidence of neurologic TEAEs was low; the most common were dizziness (21%) and dysgeusia (15%), most of which were Grade 1. The rate of treatment discontinuation due to TEAEs was 7% and the rate of dose reduction due to TEAEs was 29%.\nData Presentation and Availability\nThe data in the ESMO poster from the Response Evaluable Population, which includes all patients with measurable disease who received at least one dose of taletrectinib as of June 7, 2024, form the primary efficacy analysis that will support Nuvation Bio’s planned NDA submission in the United States.\nThe data in the ESMO abstract represent clinical results from patients enrolled at least 14 months before the data cutoff of March 29, 2024.\nThe poster presentation (abstract #1289P) will take place on Saturday, September 14, 2024, at 12:00-1:00 p.m. CEST / 6:00-7:00 a.m. EDT, and is available on Nuvation Bio’s website at www.nuvationbio.com/publications.\nAbout Taletrectinib\nTaletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.\nTaletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and Breakthrough Therapy Designations by both the U.S. FDA and China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced or metastatic ROS1+ NSCLC. Based on results of the TRUST-I clinical study, China’s NMPA has accepted and granted Priority Review Designations to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.\nIn 2021, AnHeart Therapeutics Ltd., a Nuvation Bio company, entered into an exclusive license agreement with Innovent Biologics, Inc. for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.\nAbout ROS1+ NSCLC\nEach year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of people with NSCLC have ROS1+ disease. Up to 35% of people newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for people with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.\nAbout Nuvation Bio\nNuvation Bio is a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s portfolio of development candidates includes taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, please visit www.nuvationbio.com and https://www.linkedin.com/company/nuvationbio/.\nForward Looking Statements\nCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as \"believe,\" \"may,\" \"will,\" \"estimate,\" \"continue,\" \"anticipate,\" \"intend,\" \"expect,\" \"should,\" \"would,\" \"plan,\" \"predict,\" \"potential,\" \"seem,\" \"seek,\" \"future,\" \"outlook\" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding a U.S. NDA and timing of its submission, our expectations of establishing a commercial organization, the potential for taletrectinib to become a new therapeutic option for ROS1+ NSCLC, and taletrectinib’s best-in-class therapeutic potential. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; competitive developments; and establishing commercial capabilities. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 5, 2024, under the heading \"Risk Factors,\" and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20240914324951/en/\nContacts\nNuvation Bio Investor Contact: ir@nuvationbio.com Nuvation Bio Media Contact: media@nuvationbio.com","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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":"4.29.2","shortVersion":"4.29.2","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/2467660290"}