Innovent Delivers Oral Presentation of Updated Results from a Pivotal Phase 2 Study of Dupert® (Fulzerasib) in Patients with Advanced Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation
Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor. Based on the results from this single-arm registrational Phase 2 clinical study (NCT05005234).
Dupert® (fulzerasib) received approval by the NMPA in
As of the data cutoff date (
- Fulzerasib showed encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). The disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) has not yet been reached, while the median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0). Median overall survival (OS) has not been reached.
- Fulzerasib was generally well-tolerated, with no additional safety signals observed . Treatment-related adverse events (TRAEs) occurred in 92.2% of patients (107 individuals), mostly Grade 1-2. The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia and proteinuria.
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About Dupert ® (Fulzerasib, KRAS G12C Inhibitor)
The RAS protein family is categorized into KRAS, HRAS and NRAS categories. KRAS mutation are detected in nearly 90% of pancreatic cancers, 30-40% of colon cancers, and 15-20% lung cancers. The KRAS G12C mutation is more prevalent than the combined occurrence of ALK, ROS1, RET and NTRK 1/2/3 mutations.
Fulzerasib is a novel, orally active and potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange—an essential step in pathway activation—by covalently and irreversibly modifying the cysteine residue of KRAS G12C protein. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C, leading to inhibition of downstream signaling, resulting in tumor cells apoptosis and cell cycle arrest.
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About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.
For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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