On June 1, 2025 InxMed Co., Ltd, a clinical-stage biotechnological company, pioneering therapies to transform cancer treatment, reported 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 (Press release, InxMed, JUN 1, 2025, View Source;kras-g12c-inhibitor-in-kras-g12c-mutant-solid-tumors-at-asco-2025-302470109.html [SID1234653570]).

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

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.
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 (Free ESMO Whitepaper) 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.