AMBIGUOUS RESULTS

InxMed's ifebemtinib-garsorasib combo posts 82% ORR in first-line KRAS G12C NSCLC

The chemotherapy-free oral pairing hit a response rate and 22.3-month PFS no first-line KRAS G12C regimen has cleared, in a 33-patient single-arm cohort now moving to Phase 3 confirmation.

By AppliedXLJuly 9, 2026Trial NCT06166836

Executive Summary

InxMed's oral combination of a FAK inhibitor and a KRAS G12C inhibitor produced response rates and progression-free survival in first-line lung cancer patients that no approved KRAS G12C regimen has reported in that setting.
Every approved KRAS G12C inhibitor to date treats previously treated patients; resistance has kept the mechanism out of the first-line setting, and this cohort is designed to test whether adding FAK inhibition removes that barrier.
The results come from a small, uncontrolled single-arm cohort, so the finding is a signal to be tested, not a settled benefit, and its durability will be judged against a randomized comparator in the trial now underway.
A randomized Phase 3 trial is already enrolling to confirm the result, and Chinese regulators have granted the combination a designation reserved for programs addressing high unmet need.

The data

The results come from a single-arm Phase II cohort of the Phase Ib/II trial NCT06166836, which paired InxMed's FAK inhibitor ifebemtinib (IN10018) with garsorasib (D-1553), a KRAS G12C inhibitor, in 33 first-line NSCLC patients carrying a KRAS G12C mutation. Of the 33 enrolled, 31 were evaluable; the confirmed overall response rate reached 82% across all enrolled patients and 87% among the evaluable group, with tumor shrinkage seen in every evaluable patient. Median duration of response had not been reached at data cutoff, and median progression-free survival reached 22.3 months, with 12-month and 18-month PFS rates of 67.9% and 58.2%. Median overall survival reached 27.8 months, though the company said that figure remained immature because most patients were censored before reaching it. NCT06166836+1

Probability of Success

Endpoint Met86%

Completes42%

Clinical Significance36%

Regulatory79%

How it was done

The trial is a Phase Ib/II, single-arm, open-label study run in China, registering 140 patients across dose-escalation and expansion cohorts, with the NSCLC-specific readout drawn from a 33-patient cohort dosed with ifebemtinib 100mg once daily and garsorasib 600mg twice daily, both oral. Data cutoff was September 16, 2025, with a median follow-up of 21.5 months. The trial's two registered primary endpoints are objective response rate and the recommended Phase II dose for the combination; this cohort's disclosed results speak to the response-rate endpoint. All 33 patients experienced treatment-emergent adverse events, mostly grade 1 or 2; grade 3 or 4 events occurred in 11 patients (33%), of which eight (24%) were attributed to study drugs, with no treatment-related deaths or drug discontinuations. NCT06166836+1

What it displaces

Six KRAS G12C inhibitors are approved worldwide in previously treated NSCLC, including sotorasib and adagrasib in the US and Europe and four additional agents approved in China, but none carries a first-line approval, partly because KRASG12C inhibition alone triggers resistance pathways that blunt durability. InxMed's chairman and CEO, Dr. Zaiqi Wang, said pairing the KRAS G12C inhibitor with ifebemtinib "succeeded in blocking this adaptively resistant pathway," framing the FAK addition as the mechanism behind the response depth. The company has not disclosed a comparator arm within this dataset, so the claim that FAK inhibition drives the durability rests on the single-arm result rather than a head-to-head test. InxMed

The competitive field

Direct comparators sharing the KRAS G12C target and small-molecule modality include Merck's calderasib and MK-4716 and Roche's divarasib, all still in Phase 1 or Phase 3 testing in NSCLC, with none yet reporting a first-line combination result. Across Phase 1 KRAS G12C programs in tumors of any type, 40% have failed, with two sponsors terminating trials in this target-indication pairing, a base rate against which InxMed's cohort will be measured. No competitor has disclosed a FAK-plus-KRAS-G12C first-line NSCLC combination, leaving this cohort without a direct precedent to benchmark against; the nearest context is garsorasib and other KRAS G12C monotherapies approved only in later lines.

The path forward

InxMed said ifebemtinib has received Breakthrough Therapy Designation from China's National Medical Products Administration in first-line KRASG12C-mutant NSCLC, and a randomized Phase 3 confirmatory trial, NCT07174908, is already enrolling to test whether the combination can support adoption as a front-line standard of care. The trial feeding this readout, NCT06166836, remains active and not recruiting, with a primary completion date of December 31, 2027, following a two-year extension from an original December 2025 target set earlier in the program. InxMed+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.