EMB-01, an Anti-EGFR/c-MET Bispecific Antibody, in Patients with Heavily Pretreated Metastatic Colorectal Cancer from a Phase Ib/II, Open-Label, Multicenter Study.
Ting Xu, Christine M Parseghian, Yanqiao Zhang et al.
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In 30 seconds
This phase Ib/II, open-label, multicenter study evaluated weekly intravenous EMB-01, an EGFR/c-MET bispecific antibody, in patients predominantly with heavily pretreated metastatic colorectal cancer (mCRC). Among 48 patients with mCRC, the confirmed objective response rate was 12.5% (95% CI, 4.7%-25.2%); all responses occurred in the evaluable subgroup with left-sided, RAS/RAF wild-type disease and no prior fruquintinib, regorafenib, or trifluridine-tipiracil. In that subgroup, confirmed response was 20.7% (95% CI, 8%-39.7%). Grade ≥3 treatment-related adverse events occurred in 63.5% of all enrolled patients.
Key findings
- Among 48 patients with mCRC, confirmed objective response was 12.5% (95% CI, 4.7%-25.2%); median response duration was 32 weeks (95% CI, 16-not estimable).
- In the favorable evaluable subgroup (n = 29), confirmed objective response was 20.7% (95% CI, 8%-39.7%); median progression-free survival was 19 weeks (95% CI, 12.3-24.1 weeks).
- Grade ≥3 treatment-related adverse events occurred in 63.5%; rash (25%) and dermatitis acneiform (17.3%) were the most frequent.
Why it matters
The study provides early clinical evidence of antitumor activity for EGFR/c-MET bispecific blockade in heavily pretreated mCRC, with responses concentrated in a defined subgroup. The response and progression-free survival estimates may help inform further evaluation of this approach, while the frequency of severe treatment-related events underscores the need to weigh activity against toxicity.
What to keep in mind
This was an open-label, nonrandomized phase Ib/II study with 52 patients overall; subgroup estimates were based on 29 evaluable patients.