Garsorasib

At Present Only 2 Drugs Are Approved In Market With More Than 90 Drugs In Clinical Trials KRAS-targeted therapies have emerges as a groundbreaking opportunity in oncology drug development, addressing a long-standing challenge in cancer treatment. after decades of being considered “undruggable”, the KRAS protein has finally succumbed to therapeutic intervention, opening a substantial commercial opportunity for pharmaceutical companies. The market for these therapies has shown a remarkable growth since the first approval in 2021, exceeding US$ 300 million in 2023, driven by high unmet medical needs and the prevalence of KRAS mutations in various cancers. Download KRAS Inhibitors Commercial & Clinical Development Insight As of July 2024, two KRAS targeted therapies have received approval. The first, Lumakras (sotorasib) from Amgen, was approved in May 2021 for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations. The second, Krazati (adagrasib) from Mirati Therapeutics, received approval in December 2022, also for NSCLC patients with KRAS G12C mutations. Furthermore, in June 2024, it received an accelerated approval for the treatment of adult patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in combination with Erbitux (cetuximab). These approvals have validated the KRAS-targeting approach and paved the way for further development in this space. Currently undergoing late-stage clinical trials and possibly the next in line for regulatory clearance are D-1553 (Garsorasib) from Chia Tai Tianqing Pharmaceutical, Glecirasib (JAB-21822) from Jacobio Pharma, and MK-1084 from Merck, among others. This shows the robust involvement of pharmaceutical companies around the world working to improve treatment outcomes for patients with KRAS-mutated cancers. In addition, certain regional drug regulatory agencies have accepted the New Drug Application (NDA) for Glecirasib and Garsorasib, as well as a few others. These drugs are anticipated to be approved and launched within the next year. The commercial opportunity for KRAS-targeted therapies is significant, underpinned by several key factors. KRAS mutations occur in approximately 25% of all cancers, with particularly high frequencies in pancreatic cancer, colorectal cancer and lung cancer. This translates into a substantial patient population, providing a large addressable market. While current approved therapies majorly focus on the G12C mutations, such as G12V and G12D. Success in these areas would significantly expand the market potential. Combination therapies represent another avenue for growth. KRAS inhibitors are being studies in combination with targeted therapies, immunotherapies, and standard-of-care treatments. For instance, Sidney Kimmel Comprehensive Cancer Center is conducting a Phase 1 clinical trial assessing the combination of a KRAS-targeted vaccine with Nivolumab (anti-PD-1) and Ipilimumab (anti-CTLA-4) for patients with NSCLC. Successful combinations could lead to improved efficacy, expanded indications, and increased market share. Additionally, the global potential is considerable. Initial approvals have focused on the US market, but global expansion presents significant opportunities, particularly in Europe and Asia. As precision medicines addressing a critical unmet need, KRAS-targeted therapies command premium pricing. For example, Lumakras is priced at approximately US$ 22,245 per month in the US. This pricing strategy, combined with the potential for label expansion to other KRAS-mutated cancers, further enhances the commercial prospects of these therapies. The rapid market growth and intense research activity in this field suggests that KRAS-targeted therapies will continue to be a major focus of for pharmaceutical companies and investors. As more data emerges from ongoing clinical trials and potentially new approvals are granted, the market is expected to expand significantly in the coming years, possibly reaching billions of dollars annually within the next decade.

Ifebemtinib in combination with garsorasib in NSCLC showed ORR of 90.3% and DCR of 96.8% Ifebemtinib is a highly selective, orally administered, focal adhesion kinase inhibitor with significant synergies with a broad spectrum of therapeutic modalities NANJING, China, May 30, 2024 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against tumor-treatment resistance and metastasis, today announced 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. These results will be featured in a poster presentation (Abstract: 8605 | Poster #469) at the 2024 American Society of Clinical Oncology (ASCO) 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. About InxMed InxMed Co. Ltd is a clinical-stage biotech company developing innovative therapies against tumor treatment resistance and metastasis. Established in 2018, InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed's pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, visit en.inxmed.com. SOURCE InxMed Ltd