{"id":68435,"date":"2025-06-01T12:01:42","date_gmt":"2025-06-01T12:01:42","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2025\/06\/01\/inxmed-announces-promising-phase-ib-ii-clinical-data-for-ifebemtinib-kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025\/"},"modified":"2025-06-01T12:01:42","modified_gmt":"2025-06-01T12:01:42","slug":"inxmed-announces-promising-phase-ib-ii-clinical-data-for-ifebemtinib-kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/inxmed-announces-promising-phase-ib-ii-clinical-data-for-ifebemtinib-kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025\/","title":{"rendered":"InxMed Announces Promising Phase Ib\/II Clinical Data for Ifebemtinib + KRAS G12C inhibitor in KRAS G12C-Mutant Solid Tumors at ASCO 2025"},"content":{"rendered":"<div>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">NANJING<\/span>, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">June 1, 2025<\/span><\/span> \/PRNewswire\/ &#8212; InxMed Co., Ltd, a clinical-stage biotechnological\u00a0company,\u00a0pioneering\u00a0therapies to\u00a0transform cancer treatment, released\u00a0latest clinical data from a Phase Ib\/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS G12C mutant solid tumors.<\/p>\n<p>The clinical data presented at the 2025 ASCO\u00a0Annual\u00a0Meeting\u00a0(Abstract\u00a0#8629 | Poster Board #109)\u00a0included results from two cohorts:<\/p>\n<ol type=\"1\">\n<li>Durability follow-up data of the single-arm cohort in first-line\u00a0KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.<\/li>\n<li>A randomized cohort in previously treated\u00a0KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy.\u00a0<\/li>\n<\/ol>\n<p>In NSCLC cohort, the combination of ifebemtinib and garsorasib, as a dual-oral, chemotherapy-free regimen, demonstrated compelling clinical benefit including high response rates and durable efficacy, regardless of PD-L1 expression, and in CRC cohort, the result showed clear add-on efficacy by ifebemtinib compared to KRAS inhibitor monotherapy.<\/p>\n<p><b>Key <\/b><b>Highlights in First-line <\/b><b>NSCLC: Dual-Oral Regimen Shows\u00a0Durable\u00a0Efficacy<\/b><b>\u00a0and Emerging Survival Benefit<\/b>\u00a0<\/p>\n<p>As of <span class=\"xn-chron\">March 31, 2025<\/span>, 33 first-line\u00a0NSCLC patients, regardless of PD-L1 expression, were enrolled and received the combination of ifebemtinib and garsorasib, with a median follow-up of 16.0 months.\u00a0Previously the company has reported an Objective\u00a0Response rate (ORR) of 90.3% (data presented at ESMO 2024). The follow-up data were now summarized as follows: \u00a0<\/p>\n<ul type=\"disc\">\n<li>Median progression-free survival (mPFS): 22.3 months<\/li>\n<li>Median duration of response DOR (mDOR): 19.4 months<\/li>\n<li>Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.<\/li>\n<\/ul>\n<p>Of note, the\u00a0treatment\u00a0demonstrated\u00a0consistent\u00a0efficacy regardless of PD-L1 expression\u00a0status.<\/p>\n<p><b>Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci <\/b><\/p>\n<p>As of Apr\u00a021, 2025, 36 previously\u00a0treated CRC patients were randomized 1:1\u00a0to receive\u00a0the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:<\/p>\n<ul type=\"disc\">\n<li><b>ORR<\/b>: 44.4% (combo) vs. 16.7% (mono)<\/li>\n<li><b>D<\/b><b>isease control rate (DCR)<\/b>: 100.0% (combo) vs. 77.8% (mono)<\/li>\n<li><b>mPFS<\/b>: 7.7 months (combo) vs. 4.0 months (mono)<\/li>\n<li><b>mOS<\/b>: not yet reached in the combination arm; early separation observed in the survival curves<\/li>\n<\/ul>\n<p>&#8220;These results validate ifebemtinib\u00a0as an\u00a0ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly,&#8221; said Dr. Zaiqi Wang, Chief Executive Officer of\u00a0InxMed. &#8220;The unprecedented 19-month DOR and 22-month median PFS in front-line NSCLC in all comers and near doubling of response rate in CRC position this dual-oral regimen as a potential paradigm shift\u00a0treatment in KRAS G12C-mutant cancers. Its favorable safety profile further supports the potential for a cytotoxic chemotherapy-free regimen in winning front-line in the future.&#8221;<\/p>\n<p>InxMed has initiated\u00a0a <b>randomized Phase III pivotal <\/b><b>trial<\/b>\u00a0in first-line KRAS G12C-mutant\u00a0NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including <b>KRAS G12D inhibitors<\/b> and <b>multi-RAS inhibitors<\/b>, supported by promising preclinical synergy data.<\/p>\n<p><b>About Ifebemtinib<\/b><b>\u00a0(IN10018)<\/b><\/p>\n<p>Ifebemtinib (IN10018) is a highly selective, orally administered, small molecule inhibitor against FAK, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, it\u00a0has demonstrated therapeutic synergies with chemotherapy, targeted therapies, and immunotherapies. To date, over 600 patients have been treated with a favorable safety and tolerability profile.<\/p>\n<p>Ifebemtinib has been granted <b>Breakthrough Therapy Designation<\/b> from the China National Medical Products Administration (NMPA) and <b>Fast-Track <\/b><b>D<\/b><b>esignation<\/b> from the U.S. Food and Drug Administration (FDA). A\u00a0New Drug Application submission to the NMPA\u00a0is planned for\u00a02025.<\/p>\n<p><b>About InxMed<\/b><\/p>\n<p>Founded in 2018, InxMed is a clinical-stage biotech company\u00a0dedicated to developing innovative therapies against resistance and metastasis\u00a0in cancer. The company integrates deep insights in tumor biology with translational research capabilities to develop novel therapies targeting tumor defense\u00a0mechanism. InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed is conducting a registrational trial in platinum-resistant ovarian cancer\u00a0and first-line NSCLC with KRAS G12C mutation\u00a0in <span class=\"xn-location\">China<\/span>, alongside\u00a0multiple proof-of-concept studies\u00a0in lung, colorectal, melanoma, and pancreatic cancers, with selected tumor types progressing toward pivotal trials. InxMed&#8217;s pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, please visit <a href=\"http:\/\/en.inxmed.com\/\" target=\"_blank\" rel=\"nofollow\" style=\"color: #0000FF\">en.inxmed.com<\/a>.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>NANJING, China, June 1, 2025 \/PRNewswire\/ &#8212; InxMed Co., Ltd, a clinical-stage biotechnological\u00a0company,\u00a0pioneering\u00a0therapies to\u00a0transform cancer treatment, released\u00a0latest clinical data from a Phase Ib\/II clinical trial (NCT06166836; NCT05379946) to evaluate the efficacy and safety of ifebemtinib (IN10018), an oral focal adhesion kinase (FAK) inhibitor in combination with garsorasib (D-1533), an oral KRAS G12C inhibitor, in KRAS [&#8230;]\n","protected":false},"author":1,"featured_media":79226,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-68435","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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