According to Table 2, the treatment response results are as follows: The IRC-ORR for the MRG003 treatment group and the control group were 30.2% (95% CI: 20.8%, 41.1%) and 12.6% (95% CI: 6.5%, 21.5%), respectively, with a difference of 17.6% (95% CI: 5.6%, 29.6%; P=0.0050). Subgroup analysis results for IRC-ORR are shown in Figure 3A.
At the time of the final progression-free survival analysis (June 30, 2024), the median follow-up times for the experimental group and the control group were 7.82 months and 7.23 months, respectively. According to Table 2 and Figure 2B, the IRC-PFS results are described as follows: In the MRG003 treatment group, there were 58 PFS events (67.4%), with a median PFS of 5.82 months (95% CI: 4.21, 6.24); in the control group, there were 56 PFS events (64.4%), with a median PFS of 2.83 months (95% CI: 2.00, 5.45). MRG003 reduced the risk of progression or death by 37% (HR=0.63; 95% CI: 0.43, 0.91; log-rank P=0.0146). Subgroup analysis showed that the benefit of MRG003 treatment was significant in the liver metastasis subgroup (HR=0.50; 95% CI: 0.31, 0.81).