As of data cutoff June 13, 2023, 116 patients were enrolled. The Median treatment duration was 188 days, with 37.1% remaining on treatment. Moreover, the confirmed ORR was 46.6%, meeting pre-specified endpoint. Apart from that, the disease control rate (DCR) was 90.5% with the median DoR of 8.3 months. The median progression-free survival (PFS) was 8.3 months, and median survival (OS) was not yet reached. In terms of safety, IBI351 was well tolerated, with 90.5% experiencing treatment-related adverse events (mostly grade 1-2). The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia, and proteinuria. Grade 3 or higher TRAEs occurred in 40.5% of subjects.

KOL insights

“KRAS mutation as the 'undruggable' target for decades has become one of the most popular directions for clinical development recently. Although FDA has approved KRAS G12C targeted drugs overseas, there's no drug approved in China. IBI351 is China’s first KRAS G12C inhibitor with NDA acceptance. As a selective, covalent and irreversible KRAS G12C inhibitor, IBI351 has demonstrated excellent efficacy and manageable safety in pivotal Phase 2 study. We look forward to the approval of this drug to benefit more NSCLC patients harbouring KRAS G12C mutation who have received at least one systemic therapy." –Expert Opinion.

Conclusion

In the bustling realm of KRAS G12C inhibitors, IBI351 shines as the prime choice for Chinese patients battling KRASG12C NSCLC. Its stellar efficacy and well-handled safety profile position IBI351 as a promising monotherapy, poised to emerge as a breakthrough for advanced KRASG12C mutant NSCLC patients.

Note: The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.