科伦博泰SKB264大样本疗效数据有所下滑 肺癌细分适应症仍占据优势 | 2025ASCO

Core Insights - The 2025 ASCO Annual Meeting will showcase significant research results from domestic innovative drugs, highlighting their potential in oncology treatments [1] Group 1: Clinical Data and Drug Performance - The TROP2 ADC SKB264 from Kelun-Biotech reported a 59.3% overall response rate (ORR) and a 91.4% disease control rate (DCR) in a Phase II trial for non-small cell lung cancer (NSCLC) [2] - The median progression-free survival (mPFS) for the same patient group was 15.0 months, with ORR varying by PD-L1 expression levels: 47.1% for TPS<1%, 68.1% for TPS≥1%, and 77.8% for TPS≥50% [2] - Compared to previous data, the ORR decreased from 72.7% to 59.3% in a larger sample size [2] - SKB264 demonstrated superior efficacy over other PD-1/VEGF dual antibodies, with ORR of 54.5% for SSGJ-707 and 47% for Ivosidenib [3] Group 2: Safety and Adverse Effects - The incidence of grade 3 or higher adverse reactions for SKB264 was 40%, higher than SSGJ-707's 24.1% and Ivosidenib's 29% [3] - However, the discontinuation rate due to adverse effects for SKB264 was 0%, lower than Ivosidenib's 2% and SSGJ-707's 6% [3] Group 3: Comparative Efficacy in EGFR Mutant NSCLC - In a separate study for EGFR mutant NSCLC, SKB264 showed a 45.1% ORR and mPFS of 6.9 months, statistically significant compared to Docetaxel [4] - Despite a decrease in ORR and mPFS in larger sample sizes, SKB264 still outperformed Dato-DXd (43%) and HER3-DXd (35.2%) in efficacy [4] - Other domestic competitors also showed promising results, with Ivosidenib achieving an ORR of 50.6% and BL-B01D1 reaching 52.5% in their respective trials [4][5]