On May 30, 2024 InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against tumor-treatment resistance and metastasis, reported results from the Phase Ib/II clinical trial of ifebemtinib, the company’s focal adhesion kinase (FAK) inhibitor, in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation, for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation (Press release, InxMed, MAY 30, 2024, View Source [SID1234643889]).

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These results will be featured in a poster presentation (Abstract: 8605 | Poster #469) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4, 2024, in Chicago, IL.

As of the cutoff date of May 10, 2024, a total of 33 subjects were enrolled in the study. Among the 31 evaluable patients, the antitumor responses were assessed and summarized as follows:

The objective response rate (ORR) was 90.3% (95% CI: 74.3, 98.0), and the disease control rate (DCR) was 96.8% (95% CI: 83.3, 99.9). A total of 28 partial responses (PRs) and two stable diseases (SDs) were reported. Twenty-six out of 28 PRs were confirmed thus far.
The data for median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) are still maturing.
The overall safety profile of the combination of ifebemtinib with garsorasib is consistent with either ifebemtinib or garsorasib monotherapy. Most treatment-related adverse events (AEs) were Grade 1 or 2, and some Grade 3 AEs were reported.
"The objective responses in patients exceeded our initial expectations. The combination regimen was well tolerated with known, non-overlapping, and manageable AEs from both agents," said Zhengbo Song, M.D., Associate Professor, Director of Phase 1 Unit, Zhejiang Cancer Hospital, University Chinese Academy of Sciences and Principal Study Investigator. "These data warrant further investigation to assess the potential of ifebemtinib to impact the future standard of care for KRAS G12C mutant-driven NSCLC, with or without immunotherapies in the combination regimen."

"We are highly encouraged by the results of the current clinical study of ifebemtinib in NSCLC. RAS mutations account for approximately 30 percent of all cancer patients, and KRAS mutations, including the G12C mutation, wreak havoc in many people with solid tumors, including lung, pancreatic, and colorectal cancers," stated James McLeod, M.D., Chief Medical Officer of InxMed. "With recent rapid advances in KRAS G12C inhibitors comes the need for further improving clinical responses and safety/tolerability profiles of treatment regimens. We have studied FAK tumor biology and designed the combination therapy with KRAS inhibitors based on our deep understanding of FAK’s roles in the tumor defense mechanism. We are pleased to see that ifebemtinib significantly amplifies the clinical responses of the combination regimen."

Dr. McLeod added, "The current data set, albeit early with PFS and DOR data, is still maturing but is consistent with the results from our clinical trials in other tumor types. These initial findings demonstrate the potential of ifebemtinib to become an anchor component in combination regimens with chemotherapies, targeted therapies, or immunotherapies. We will continue further exploring the clinical utility of ifebemtinib in combination therapy and certainly welcome collaborations with global leaders in cancer therapies."

About Ifebemtinib
Ifebemtinib (IN10018, BI853520) is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has significant synergies with a broad spectrum of therapeutic modalities. Clinically, ifebemtinib has demonstrated therapeutic synergies with chemotherapy agents, targeted therapies, and immunotherapies. InxMed is currently pursuing a registrational trial in platinum-resistant ovarian cancer in China, and multiple proof-of-concept trials are ongoing in lung, colorectal, melanoma, and pancreatic cancers, with select tumor types to progress into pivotal clinical trials. Thus far, more than 600 patients have been treated with ifebemtinib, and a favorable safety and tolerability profile was observed.

Ifebemtinib was 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). InxMed plans to submit a New Drug Application to the NMPA in early 2025.