Immutep receives FDA agreement on optimal dose for efti and advances Phase III lung cancer trial in US

Reuters

Oct 13

Immutep receives FDA agreement on optimal dose for efti and advances Phase III lung cancer trial in US

Immutep Ltd. has announced the successful completion of the US FDA's Project Optimus requirements, confirming 30mg of eftilagimod alfa (efti) as the optimal biological dose for its oncology pipeline. This regulatory milestone paves the way for future Biological License Applications (BLA) and supports the ongoing global Phase III TACTI-004 (KEYNOTE-F91) trial. The trial is evaluating efti in combination with Merck's KEYTRUDA® (pembrolizumab) and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer, with clinical sites now in the process of opening in the United States. No new grant or funding announcement involving multiple organizations was disclosed.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immutep Ltd. published the original content used to generate this news brief on October 13, 2025, and is solely responsible for the information contained therein.

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This regulatory milestone paves the way for future Biological License Applications (BLA) and supports the ongoing global Phase III TACTI-004 (KEYNOTE-F91) trial. The trial is evaluating efti in combination with Merck's KEYTRUDA® (pembrolizumab) and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer, with clinical sites now in the process of opening in the United States. No new grant or funding announcement involving multiple organizations was disclosed.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immutep Ltd. published the original content used to generate this news brief on October 13, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0106261372.USD","symbol_name":"SCHRODER ISF US LARGE CAP \"A\" ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251012:nNDL4wdFYh:1","article_id":"2575443423","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2575443423","pubTimestamp":1760308276,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Immutep Ltd. has announced the successful completion of the US FDA's Project Optimus requirements, confirming 30mg of eftilagimod alfa  as the optimal biological dose for its oncology pipeline. This regulatory milestone paves the way for future Biological License Applications  and supports the ongoing global Phase III TACTI-004  trial. The trial is evaluating efti in combination with Merck's KEYTRUDA  and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer, with clinical sites now in the process of opening in the United States. No new grant or funding announcement involving multiple organizations was disclosed.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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This regulatory milestone paves the way for future Biological License Applications (BLA) and supports the ongoing global Phase III TACTI-004 (KEYNOTE-F91) trial. The trial is evaluating efti in combination with Merck's KEYTRUDA® (pembrolizumab) and chemotherapy as a first-line treatment for advanced or metastatic non-small cell lung cancer, with clinical sites now in the process of opening in the United States. No new grant or funding announcement involving multiple organizations was disclosed.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immutep Ltd. published the original content used to generate this news brief on October 13, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}