Garsorasib
- Generic Name
- Garsorasib
- Brand Names
- 安方宁
FDA Approves Lumakras and Vectibix Combination for KRAS G12C-Mutated Metastatic Colorectal Cancer
• The FDA has approved Lumakras (sotorasib) combined with Vectibix (panitumumab) for treating KRAS G12C-mutated metastatic colorectal cancer in adults after prior chemotherapy.
• CodeBreaK 300 trial data showed the combination significantly improved progression-free survival compared to standard of care in chemorefractory patients.
• Patients on Lumakras and Vectibix had a median progression-free survival of 5.6 months, compared to 2 months on standard of care, with a 26% overall response rate.
• This approval provides a new targeted treatment option for a subset of colorectal cancer patients with limited alternatives, emphasizing the importance of biomarker testing.
Yifang Biopharma's TYK2 Inhibitor D-2570 Shows Promising Phase II Results in Psoriasis Treatment
• Yifang Biopharma's TYK2 inhibitor, D-2570, demonstrated significant efficacy in a Phase II trial for moderate to severe plaque psoriasis, with high PASI 75 response rates across multiple dose groups.
• The Phase II trial of D-2570 met its primary endpoint, showing statistically significant improvements in psoriasis symptoms compared to placebo, with a favorable safety profile.
• Gesolexab (D-1553), a KRAS G12C inhibitor developed by Yifang Biopharma, has completed first subject enrollment in Phase III clinical study for non-small cell lung cancer.
• D-0502, an oral selective estrogen receptor degrader (SERD), is currently in Phase III clinical trials for second-line treatment of ER-positive, HER2-negative breast cancer, showing promising clinical benefit.
InxMed's Ifebemtinib Receives Breakthrough Therapy Designation for NSCLC with KRAS G12C Mutation
• InxMed's ifebemtinib has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for first-line treatment of NSCLC with KRAS G12C mutation.
• The BTD is supported by Phase Ib/II study data, showcasing a 90.3% objective response rate and a 96.8% disease control rate when combined with garsorasib.
• Ifebemtinib, a FAK inhibitor, has shown synergies with targeted therapies and immunotherapies, with ongoing trials in multiple cancer types.
• InxMed plans to submit a New Drug Application in 2025 for platinum-resistant ovarian cancer, with several proof-of-concept trials underway.
Sino Biopharm's Garsorasib Approved in China for Advanced NSCLC
• Sino Biopharmaceutical's Garsorasib, a KRAS G12C inhibitor, has been approved in China for treating advanced non-small cell lung cancer (NSCLC).
• Clinical trials demonstrated that Garsorasib significantly improved survival rates compared to existing treatment options for NSCLC patients.
• This approval positions Garsorasib as a key precision-targeted therapy, potentially expanding to other cancer indications in the future.
KRAS Inhibitors Market Set for Growth with Novel Therapies Targeting Key Mutations in Cancer
• The KRAS inhibitors market is projected to grow significantly, driven by increasing cancer incidence and advancements in targeted therapies.
• KRAZATI (adagrasib) is expected to lead in revenue among approved KRAS inhibitors, surpassing LUMAKRAS (sotorasib) during the forecast period.
• Pan-KRAS drugs, targeting multiple KRAS mutations, hold substantial market potential due to their broader applicability across cancer types.
• Emerging therapies like JDQ443 and avutometinib are poised to transform the treatment landscape, offering new options for patients with KRAS-mutated cancers.
Drug Development Updates
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