InxMed Announces Promising Phase Ib/II Clinical Data for Ifebemtinib + KRAS G12C inhibitor in KRAS G12C-Mutant Solid Tumors at ASCO 2025

NANJING, China, June 1, 2025 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, released 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.

The clinical data presented at the 2025 ASCO Annual Meeting (Abstract #8629 | Poster Board #109) included results from two cohorts:

1. Durability follow-up data of the single-arm cohort in first-line KRAS G12C-mutant non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 expression, who received ifebemtinib + garsorasib treatment.
2. A randomized cohort in previously treated KRAS G12C-mutant colorectal cancer (CRC) patients comparing ifebemtinib+ garsorasib versus garsorasib monotherapy. 

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.

Key Highlights in First-line NSCLC: Dual-Oral Regimen Shows Durable Efficacy and Emerging Survival Benefit 

As of March 31, 2025, 33 first-line 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. Previously the company has reported an Objective Response rate (ORR) of 90.3% (data presented at ESMO 2024). The follow-up data were now summarized as follows:  

• Median progression-free survival (mPFS): 22.3 months
• Median duration of response DOR (mDOR): 19.4 months
• Median overall survival (mOS): not yet reached, with a significant uplifting and flattening survival curve indicating durable benefit.

Of note, the treatment demonstrated consistent efficacy regardless of PD-L1 expression status.

Key Findings in Previously Treated CRC: Randomized Trial Validates Synergy with KRAS G12Ci

As of Apr 21, 2025, 36 previously treated CRC patients were randomized 1:1 to receive the combination of ifebemtinib + garsorasib or garsorasib alone. All patients were radiologically evaluable and the antitumor responses were assessed and summarized as follows:

• ORR: 44.4% (combo) vs. 16.7% (mono)
• Disease control rate (DCR): 100.0% (combo) vs. 77.8% (mono)
• mPFS: 7.7 months (combo) vs. 4.0 months (mono)
• mOS: not yet reached in the combination arm; early separation observed in the survival curves

"These results validate ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy of RASi significantly," said Dr. Zaiqi Wang, Chief Executive Officer of InxMed. "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 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."

InxMed has initiated a randomized Phase III pivotal trial in first-line KRAS G12C-mutant NSCLC. Additionally, the company is actively exploring combinations of ifebemtinib with other KRAS-targeted agents, including KRAS G12D inhibitors and multi-RAS inhibitors, supported by promising preclinical synergy data.

About Ifebemtinib (IN10018)

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 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.

Ifebemtinib has been granted Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) and Fast-Track Designation from the U.S. Food and Drug Administration (FDA). A New Drug Application submission to the NMPA is planned for 2025.

About InxMed

Founded in 2018, InxMed is a clinical-stage biotech company dedicated to developing innovative therapies against resistance and metastasis in cancer. The company integrates deep insights in tumor biology with translational research capabilities to develop novel therapies targeting tumor defense 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 and first-line NSCLC with KRAS G12C mutation in China, alongside multiple proof-of-concept studies 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 en.inxmed.com.