<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/ -- InxMed Co., Ltd, a clinical-stage biotechnological&nbsp;company,&nbsp;pioneering&nbsp;therapies to&nbsp;transform cancer treatment, released&nbsp;latest 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>  <p>The clinical data presented at the 2025 ASCO&nbsp;Annual&nbsp;Meeting&nbsp;(Abstract&nbsp;#8629 | Poster Board #109)&nbsp;included results from two cohorts:</p>  <ol type="1">   <li>Durability follow-up data of the single-arm cohort in first-line&nbsp;KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.</li>   <li>A randomized cohort in previously treated&nbsp;KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy.&nbsp;</li>  </ol>  <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>  <p><b>Key </b><b>Highlights in First-line </b><b>NSCLC: Dual-Oral Regimen Shows&nbsp;Durable&nbsp;Efficacy</b><b>&nbsp;and Emerging Survival Benefit</b>&nbsp;</p>  <p>As of <span class="xn-chron">March 31, 2025</span>, 33 first-line&nbsp;NSCLC 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.&nbsp;Previously the company has reported an Objective&nbsp;Response rate (ORR) of 90.3% (data presented at ESMO 2024). The follow-up data were now summarized as follows: &nbsp;</p>  <ul type="disc">   <li>Median progression-free survival (mPFS): 22.3 months</li>   <li>Median duration of response DOR (mDOR): 19.4 months</li>   <li>Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.</li>  </ul>  <p>Of note, the&nbsp;treatment&nbsp;demonstrated&nbsp;consistent&nbsp;efficacy regardless of PD-L1 expression&nbsp;status.</p>  <p><b>Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci </b></p>  <p>As of Apr&nbsp;21, 2025, 36 previously&nbsp;treated CRC patients were randomized 1:1&nbsp;to receive&nbsp;the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:</p>  <ul type="disc">   <li><b>ORR</b>: 44.4% (combo) vs. 16.7% (mono)</li>   <li><b>D</b><b>isease control rate (DCR)</b>: 100.0% (combo) vs. 77.8% (mono)</li>   <li><b>mPFS</b>: 7.7 months (combo) vs. 4.0 months (mono)</li>   <li><b>mOS</b>: not yet reached in the combination arm; early separation observed in the survival curves</li>  </ul>  <p>&quot;These results validate ifebemtinib&nbsp;as an&nbsp;ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly,&quot; said Dr. Zaiqi Wang, Chief Executive Officer of&nbsp;InxMed. &quot;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&nbsp;treatment 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.&quot;</p>  <p>InxMed has initiated&nbsp;a <b>randomized Phase III pivotal </b><b>trial</b>&nbsp;in first-line KRAS G12C-mutant&nbsp;NSCLC. 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>  <p><b>About Ifebemtinib</b><b>&nbsp;(IN10018)</b></p>  <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&nbsp;has 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>  <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&nbsp;New Drug Application submission to the NMPA&nbsp;is planned for&nbsp;2025.</p>  <p><b>About InxMed</b></p>  <p>Founded in 2018, InxMed is a clinical-stage biotech company&nbsp;dedicated to developing innovative therapies against resistance and metastasis&nbsp;in cancer. The company integrates deep insights in tumor biology with translational research capabilities to develop novel therapies targeting tumor defense&nbsp;mechanism. 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&nbsp;and first-line NSCLC with KRAS G12C mutation&nbsp;in <span class="xn-location">China</span>, alongside&nbsp;multiple proof-of-concept studies&nbsp;in lung, colorectal, melanoma, and pancreatic cancers, with selected tumor types progressing toward pivotal trials. InxMed'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>