Erbitux (cetuximab)

P1/2, N=29, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Feb 2030 --> Jun 2026

P2, N=150, Not yet recruiting, Verastem, Inc.

The biomarker data supported the mechanism of action involving the upregulation of CD8+ T cells and NK cells. ClinicalTrials.gov Identifier: NCT05104567.

P1/2, N=58, Completed, Associacio Per A La Recerca Oncologica | Phase classification: P=N/A --> P1/2 | --> Completed

P2, N=28, Completed, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting --> Completed

Histopathological analysis confirmed that therapeutic efficacy was driven by a significant reduction in EGFR protein levels. Our findings establish Hsp90-mediated stabilization of monomeric EGFR as a novel resistance mechanism and provide a translational rationale for employing low-dose Hsp90 inhibition in combination with cetuximab to improve clinical outcomes for HNSCC patients currently lacking effective targeted options.

MiR-31-3p is a promising predictive biomarker for cetuximab response in RAS wild-type mCRC, with low expression consistently associated with improved outcomes. However, tumor sidedness may modulate its predictive value. Prospective validation studies with standardized assays are needed before clinical implementation. Integration of miR-31-3p with existing markers could help identify patients unlikely to benefit from anti-EGFR therapy.

P1, N=12, Terminated, Biond Biologics | N=280 --> 12 | Trial completion date: Nov 2027 --> Apr 2026 | Recruiting --> Terminated | Trial primary completion date: Sep 2027 --> Apr 2026; Study terminated due to strategic considerations

For OS, both cetuximab + chemotherapy [hazard ratio (HR)=0.853; 95% CI: 0.775-0.938; P=0.001] and panitumumab + chemotherapy (HR=0.855; 95% CI: 0.738-0.992; P=0.038) exhibited statistically significant superiority compared with bevacizumab + chemotherapy...In the present sensitivity analysis, UDP glucuronosyltransferase family 1 member A1-guided bevacizumab + 5-fluorouracil, leucovorin and irinotecan demonstrated favorable outcomes, with OS and PFS P-scores of 0.932 and 0.992, respectively; however, these findings were derived from a single trial with limited comparability...Treatment benefit from anti-EGFR therapy was markedly influenced by primary tumor location, with notable benefit observed in left-sided tumors and no benefit in right-sided tumors. These findings support tumor sidedness-guided treatment selection in clinical practice, favoring anti-EGFR-based therapy for left-sided and bevacizumab-based therapy for right-sided RAS wild-type mCRC.

P1/2, N=383, Active, not recruiting, MedImmune LLC | Trial completion date: Sep 2025 --> Jul 2027

P2, N=7, Terminated, Northwestern University | Trial completion date: Jul 2030 --> Apr 2026 | Active, not recruiting --> Terminated | Trial primary completion date: May 2026 --> Oct 2025; The study was closed due to accrual.

In cisplatin-ineligible populations, ICI regimens did not improve PFS compared with cetuximab plus RT. This study showed that although in the overall population there was no significant difference in EFS/PFS/DFS, in the PD-L1-positive subgroup, patients experienced significantly improved PFS with ICIs compared with control, while in the PD-L1-negative subgroup, patients demonstrated inferior PFS in the ICIs arm; these results were mirrored in the cisplatin-eligible subgroup.