PT  - JOURNAL ARTICLE
AU  - Bai, Ming
AU  - Lu, Yao
AU  - Shi, Chunmei
AU  - Yang, Jianwei
AU  - Li, Wei
AU  - Yin, Xianli
AU  - Huang, Chenghui
AU  - Shen, Lin
AU  - Xie, Liangzhi
AU  - Ba, Yi
TI  - Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer
AID  - 10.20892/j.issn.2095-3941.2023.0301
DP  - 2023 Dec 23
TA  - Cancer Biology & Medicine
PG  - 20230301
4099  - http://www.cancerbiomed.org/content/early/2023/12/22/j.issn.2095-3941.2023.0301.short
4100  - http://www.cancerbiomed.org/content/early/2023/12/22/j.issn.2095-3941.2023.0301.full
AB  - Objective: This study evaluated the safety and efficacy of an anti-epidermal growth factor receptor (EGFR) antibody (SCT200) and an anti-programmed cell death 1 (PD-1) antibody (SCT-I10A) as third-line or subsequent therapies in patients with rat sarcoma viral oncogene (RAS)/v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (wt) metastatic colorectal cancer (mCRC).Methods: We conducted a multicenter, open-label, phase Ib clinical trial. Patients with histologically confirmed RAS/BRAF wt mCRC with more than two lines of treatment were enrolled and treated with SCT-I10A and SCT200. The primary endpoints were the objective response rate (ORR) and safety. The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).Results: Twenty-one patients were enrolled in the study through January 28, 2023. The ORR was 28.57% and the DCR was 85.71% (18/21). The median PFS and OS were 4.14 and 12.84 months, respectively. The treatment-related adverse events (TRAEs) were tolerable. Moreover, compared with the monotherapy cohort from our previous phase I study evaluating SCT200 for RAS/BRAF wt mCRC in a third-line setting, no significant improvements in PFS and OS were observed in the combination group.Conclusions: SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt mCRC patients with an acceptable safety profile. Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting. (Registration No. NCT04229537).The data generated in this study are available upon request from the corresponding author.