# InxMed Announces Publication in The Lancet Respiratory Medicine Featuring Promising Anticancer Activity of Ifebemtinib in combination with Garsorasib in First-Line non-small cell lung cancer (NSCLC) Harboring KRAS G12C Mutation

- Link: https://www.thailand-business-news.com/pr-news/inxmed-announces-publication-in-the-lancet-respiratory-medicine-featuring-promising-anticancer-activity-of-ifebemtinib-in-combination-with-garsorasib-in-first-line-non-small-cell-lung-cancer-nsclc-h
- Published: 2026-07-09T16:28:00+07:00
- Author: PR Newswire

NANJING, China, July 9, 2026 /PRNewswire/ — InxMed Co., Ltd ("InxMed"), a clinical-
stage biotechnology company dedicated to developing innovative therapies targeting
cancer treatment resistance and metastasis, today announced that the clinical results
of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor,
in combination with garsorasib (D-1553), a potent KRAS^(G12C) inhibitor in first-
line _KRAS__^(G12C)_-mutant NSCLC, have been published online in **_The Lancet Respiratory
Medicine_**.

The data were derived from a phase Ib/II trial evaluating the efficacy and safety
of ifebemtinib plus garsorasib in _KRAS__^(G12C)_-mutant solid tumors (NCT06166836/
NCT05379946), where ifebemtinib plus garsorasib, as an all‑oral, chemotherapy‑free
regimen, demonstrated impressive results in patients with first-line _KRAS__^(G12C)_-
mutant NSCLC.

**Promising Antitumor Efficacy and Manageable Safety Profile**

33 first-line NSCLC patients with _KRAS__^(G12C)_-mutation were enrolled in the 
single-arm phase II cohort and received ifebemtinib (100mg once a day) and garsorasib(
600mg twice a day) orally. By data cutoff on September 16, 2025 reported in this
paper, the median follow-up duration was 21.5 months. Ifebemtinib in combination
with garsorasib demonstrated a high response rate and durable responses in first-
line _KRAS__^(G12C)_-mutation NSCLC, increasing the possibility of a paradigm shift,
which, if confirmed in currently ongoing phase 3 trial (NCT07174908), could substantially
impact the current treatment options for this patient population.

Key findings published in this paper:

 ◦ High Response Rates: Of the 33 enrolled patients, 31 were evaluable. The cORR
   was 82% (27/33) across all enrolled patients and 87% (27/31) among evaluable 
   patients. And tumor shrinkage was observed in all evaluable patients, even in
   the patient with best overall response of PD.
 ◦ Durable Responses: Among responders, the median Duration of Response (DOR) was
   Not Reached (NR) (95% CI: 15.2–NE), underscoring the potential of FAK inhibition
   to prevent or significantly delay treatment resistance.
 ◦ Prolonged survival benefit of PFS and overall survival (OS): The mPFS reached
   an extraordinary 22.3 months (95% CI: 9.6–NE), with 12-month and 18-month PFS
   rates standing at 67.9% and 58.2%, respectively. The median OS was 27.8 months(
   95% CI: 27.8–NE), which remained immature as most patients was censored before
   27.8 months. The 12-month and 24-month OS rates were 75.8% and 69.7%, respectively.
 ◦ Manageable safety profile: All 33 patients experienced treatment-emergent adverse
   events (TEAE). Most of the TEAE were grade 1 or 2; grade 3 or 4 events occurred
   in 11 (33%) of 33 patients, of which eight (24%) were related to study drugs.
   No treatment-related death or treatment-related AEs leading to drug discontinuation
   were reported.

"The publication of our long-term follow-up data in _The Lancet Respiratory Medicine_
serves as a momentous validation of our translational science," said Dr. Zaiqi Wang,
Chairman and Chief Executive Officer of InxMed. "By pairing KRAS^(G12C) inhibitor
with our FAK inhibitor ifebemtinib, we have succeeded in blocking this adaptively
resistant pathway. An ORR of 82% and a median PFS of over 22 months in the first-
line setting represents a paradigm shift, offering these patients a highly potent,
completely chemotherapy-free and all-oral option."

**Overcoming Resistance by FAK Inhibition When Targeting ****_KRAS_****_^(G12C)_**

_KRAS__^(G12C)_ mutations occur in roughly 12-14% of NSCLC cases. Currently there
were six KRAS^(G12C) inhibitors approved in previously-treated _KRAS__^(G12C)_-mutant
NSCLC, including sotorasib and adagrasib (approved in the USA and Europe) and fulzerasib,
garsorasib, glecirasib and sosimerasib (approved in China). However, no KRAS^(G12C)
inhibitors monotherapy or combination regimens were approved in first-line settings
partially due to primary or acquired resistance when targeting _KRAS__^(G12C)_ alone.
InxMed’s translational research showed that KRAS^(G12C) inhibition alone triggers
adaptive hyperactivation of the FAK‑YAP signaling pathway, promotes fibrogenesis
in the tumor microenvironment, and thereby enhances tumor cell survival. And FAK
inhibition by Ifebemtinib disrupts this resistance mechanism, sensitizing tumor 
cells to KRAS^(G12C) inhibition and prolonging the duration of treatment response.

Based on these promising clinical data, ifebemtinib has been granted Breakthrough
Therapy Designation (BTD) in first-line NSCLC harboring _KRAS__^(G12C)_ mutation
from the China National Medical Products Administration (NMPA). InxMed is progressing
its clinical development plan, including an ongoing randomized Phase III confirmatory
trial (NCT07174908) intended to support the adoption of this all‑oral, chemotherapy-
free regimen as a new standard of care in the front‑line setting.

Based on a robust translational medicine foundation and compelling clinical evidence,
Ifebemtinib is poised to become a revolutionary therapeutic that could fundamentally
reshape the RAS-targeted treatment paradigm. InxMed is strategically driving a comprehensive
development program for Ifebemtinib across RAS-mutant tumors, with combination regimens
already initiated or in preparation not only with KRAS G12C inhibitors, but also
with _KRAS__^(G12D)_ inhibitors and multi‑RAS inhibitors, among other novel classes,
underscoring the company’s commitment to transforming the future of RAS-addicted
cancers.

**About Ifebemtinib (IN10018)**

Ifebemtinib (IN10018) is an orally available, highly potent, and selective small-
molecule inhibitor of focal adhesion kinase (FAK). InxMed holds exclusive global
development and commercialization rights. Clinically, ifebemtinib has demonstrated
excellent safety and tolerability in over 700 subjects globally, showing vast potential
as a "backbone" combination partner across multiple modalities, including RAS inhibitors,
immune checkpoint blockades, and antibody-drug conjugates (ADCs). It has received
multiple Breakthrough Therapy Designations from the NMPA and Fast Track Designation
from the U.S. FDA.

**About InxMed**

Founded in 2017, InxMed is a late clinical-stage biotechnology company dedicated
to tackling a central challenge in cancer therapy—drug resistance caused by tumor
defense mechanisms. Our strategy focuses on critical signaling hubs shared across
multiple tumor types, most notably the focal adhesion kinase (FAK) and integrin 
pathways, which play pivotal roles in tumor cell survival and contribute to treatment
failure across various therapeutic modalities. In parallel, we target cancer-associated
fibroblasts (CAFs) to dismantle the protective barrier around tumor cells. Through
these integrated efforts, we aim to redefine cancer treatment and pioneer new frontiers
in therapeutic innovation.  For more information, please visit [en.inxmed.com](https://en.inxmed.com/).

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