Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its Phase II clinical trial results for Dupert (fulzerasib) have been selected for an oral presentation at the 2024 World Conference on Lung Cancer (WCLC). The study, known as HARMONi-2 (AK112-303), focuses on the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) that harbors the KRAS G12C mutation.
Dupert, a first-in-class, orally active, potent KRAS G12C inhibitor, has shown promising results in the trial. As of the data cutoff on December 13, 2023, the study enrolled 116 evaluable NSCLC subjects. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1%, with a disease control rate (DCR) of 90.5%. The median duration of response (DoR) has not yet been reached, while the median progression-free survival (PFS) was 9.7 months. The median overall survival (OS) has not been reached.
In terms of safety, fulzerasib was generally well-tolerated, with treatment-related adverse events (TRAEs) occurring in 92.2% of patients, mostly Grade 1-2. The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia, and proteinuria. These results are consistent with previous reports, and the overall tolerability was good, with no new safety signals observed.
Dupert (fulzerasib) received marketing approval in China in August 2024 for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy. The drug is also being investigated in combination with EGFR inhibitors, which may offer a synergistic effect and the possibility of first-line treatment. A European study initiated last year is currently exploring this combination, with preliminary Phase II data demonstrating an 81.8% objective response rate. – Flcube.com
