JMT101 Plus Irinotecan and SG001 Shows Promise in Metastatic Colorectal Cancer
According to results from a phase 2 study, JMT101, a humanized IgG1 anti-EGFR monoclonal antibody, plus irinotecan with or without SG001, a humanized IgG4 anti PD-1 monoclonal antibody, demonstrated promise among patients with metastatic colorectal cancer.
These data were first presented by Jianmin Xu, PhD, Fudan University, Shanghai, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this multicenter, open-label trial, researchers enrolled 109 patients with RAS or BRAF wild-type metastatic colorectal cancer who were neither microsatellite instability-high nor mismatch repair deficient who experienced disease progression after ≥ 2 lines of prior systemic therapy. Three patients were enrolled in a safety run-in to receive 6 mg/kg of JMT101 plus 180 mg/m2 of irinotecan and 240 mg of SG001 once every 2 weeks. Following dose confirmation, 106 additional patients were randomized on a 1-to-1-to-1 basis to receive either JMT101 plus irinotecan and SG001 (n = 36), JMT101 plus irinotecan (n = 35), or 160 mg of regorafenib on days 1 through 21 of each 28-day cycle (n = 35). The primary end point was objective response rate (ORR). Key secondary end points included disease control rate, duration of response, median progression-free survival (PFS), and safety.
At a median follow-up of 7.4 months, the ORR was 44.1% in arm A, 34.3% in arm B, and 2.9% in arm C. Disease control rate was 82.4%, 86.7%, and 61.8%, respectively. Duration of response was 48 months in arm A, 71.4 months in arm B, and not evaluable in arm C. Median PFS was 5.7 months, 7.4 months, and 2.9 months, respectively. Grade ≥ 3 treatment-related adverse events occurred in 38.9% of patients in arm A, 54.3% of patients in arm B, and 48.6% of patients in arm C. Treatment-related adverse events led to treatment discontinuation in 5.7% of patients in arm C. No treatment-related adverse events led to death.
“Results demonstrated a promising response rate and a tolerable safety profile of JMT101 + irinotecan +/- SG001,” concluded Dr Xu et al. “Preliminary data support continued investigation, with updated results to follow.”
Source:
Xu J, Tang W, Lin R, et al. JMT101 in combination with irinotecan and SG001 versus regorafenib in patients with metastatic colorectal adenocarcinoma (mCRC): Results of a randomized, controlled, open-label, phase II study. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract LBA3516
