By December 30,2024, the median total treatment duration in the trial group (N=86) was 139.0 days (range: 21 to 621 days), and in the control group (N=87) it was 66.0 days (range: 20 to 557 days).
The AE summary is described in Supplementary Table 1. The most common TEAEs and TRAEs are described in Table 3 and Supplementary Table 2, with a focus on TRAEs and their corresponding incidence rates of Grade 3 or higher.
In the MRG003 treatment group, 4 patients (4.7%) experienced AESIs, all occurring during treatment (1 case of Grade 3 bowel obstruction, 2 cases of Grade 2 bowel obstruction, and 1 case of Grade 2 idiopathic interstitial pneumonia). Among these, the outcome for the 1 case of Grade 2 idiopathic interstitial pneumonia was recovering/improving, while the other AESIs had resolved. In the MRG003 treatment group, 3 patients (3.5%) died due to AEs (2 cases due to pulmonary infection and 1 case due to severe pneumonia caused by MRSA, methicillin-resistant Staphylococcus aureus). In the control group, 7 patients (8.0%) died (1 case due to tumor hemorrhage, 3 cases due to metastatic nasopharyngeal carcinoma, 1 case due to infectious pneumonia, 1 case due to decreased platelet count, and 1 case of unknown cause).