On August 11, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) indicated that InxMed’s application for IN10018 tabletshas been proposed for breakthrough therapy designation, intended for combination with D-1553 to treat locally advanced or metastatic KRAS G12C mutation-positive colorectal cancer (CRC)that has received at least two prior lines of therapy.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
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.
At the 2025 ASCO Annual Meeting,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:
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 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
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Post time: Aug-13-2025