Ifebemtinib Plus Garsorasib as First-Line Treatment in Patients With KRAS G12C-Mutated Non-Small Cell Lung Cancer: A Phase Ib/II Study

SHANGHAI—In a crowded field of lung cancer treatments, a Chinese biotech company is claiming a breakthrough that could reshape how doctors tackle one of the disease's most stubborn forms.

InxMed Limited said Tuesday that a combination of its experimental drug ifebemtinib with garsorasib shrank tumors in 87% of previously untreated patients with a specific type of advanced lung cancer, according to data published in The Lancet Respiratory Medicine.

The results, from a mid-stage clinical trial involving 33 patients, offer a potential new option for those with KRAS G12C-mutated non-small cell lung cancer—a form of the disease that has long resisted targeted therapies.

"The clinical data reported in this article provide strong support for ifebemtinib combined with KRAS G12C inhibitors in first-line KRAS G12C-mutated NSCLC," the company said in a statement.

A Dual-Drug Approach

The treatment pairs ifebemtinib, a FAK inhibitor taken as a 100-milligram daily pill, with garsorasib, a KRAS G12C inhibitor taken at 600 milligrams twice daily. Both are oral medications, meaning patients avoid the infusions typical of chemotherapy.

The Phase Ib/II trial, registered as NCT06166836 and NCT05379946, enrolled patients with previously untreated KRAS G12C-mutated non-small cell lung cancer. Researchers tracked outcomes in 31 patients who could be evaluated for efficacy.

With a median follow-up of 21.5 months and data cut off in September 2025, the combination showed an objective response rate of 87.1%—meaning tumors shrank by a predefined amount in 27 of 31 patients. All evaluable patients saw their tumors reduce from baseline.

Survival Data

The median duration of response had not been reached, with a 95% confidence interval of 15.2 months to not estimable.

Median progression-free survival was 22.3 months (95% CI: 9.6 months to not estimable). At 12 months, 67.9% of patients remained progression-free; at 18 months, 58.2% remained so.

Median overall survival was 27.8 months (95% CI: 27.8 months to not estimable), though the company noted the data are not yet mature. The 12-month overall survival rate was 75.8%, and the 24-month rate was 69.7%.

Safety Profile

All 33 patients reported at least one treatment-emergent adverse event, though most were mild to moderate. Grade 3 or 4 adverse events occurred in 33% of patients, with 24% judged related to the study drugs.

No fatal adverse events or events leading to permanent discontinuation were reported.

The KRAS Challenge

KRAS G12C mutations occur in roughly 1.4% to 4.3% of lung cancer cases in Asian populations. While KRAS G12C inhibitors have shown activity in previously treated patients, first-line treatment has remained dominated by immunotherapy combined with chemotherapy.

Preclinical research suggests ifebemtinib may enhance the effectiveness of KRAS G12C inhibitors by blocking compensatory FAK-YAP signaling pathways, reducing tumor fibrosis, and promoting the infiltration of cancer-killing T cells.

Regulatory Momentum

Ifebemtinib has already received three Breakthrough Therapy Designations from China's National Medical Products Administration and one Fast Track designation from the U.S. Food and Drug Administration.

InxMed is now accelerating a randomized, controlled Phase III confirmatory trial (NCT07174908), which launched in the fourth quarter of 2025. The study plans to enroll patients across approximately 90 research centers in China, including Shanghai Chest Hospital, Zhejiang Cancer Hospital, Beijing Cancer Hospital, and seven other major institutions.

About InxMed

Founded in 2017, InxMed is a clinical-stage biotechnology company focused on overcoming drug resistance and metastasis in solid tumors. The company targets critical signaling hubs in cancer cells, particularly focal adhesion kinase and integrin pathways, while also disrupting the protective barriers surrounding tumors.

The company has established partnerships with multinational pharmaceutical companies and biotech firms globally. Its core team includes veterans from Roche, Novartis, Merck, GlaxoSmithKline, Johnson & Johnson, and BeiGene, who have led the clinical development and registration of more than a dozen drugs in China, including Keytruda and Gardasil.

Source: InxMed company announcement. Data from Phase Ib/II clinical trial NCT06166836/NCT05379946, published in The Lancet Respiratory Medicine on July 7, 2026.