- In a study of patients with anti-epidermal growth factor receptor (EGFR) therapy-resistant, MET-high metastatic colorectal cancer (mCRC), tivantinib+cetuximab failed to meet the primary endpoint of overall response.
Why this matters
- A significant unmet need persists for therapeutic approaches able to overcome resistance to current therapies.
- Phase 2 study of tivantinib+cetuximab in 41 patients with KRAS wild-type mCRC with EGFR inhibitor resistance and MET overexpression.
- All patients achieved stable disease or better on the last regimen containing cetuximab or panitumumab and had progressed in the 3 months before study enrollment.
- Funding: Daiichi Sankyo, Humanitas Clinical and Research Center.
- 9.8% objective response rate (4 of 5 patient responses required to meet the primary endpoint).
- 2.4% achieved complete response, 7.3% achieved partial response.
- Median PFS: 2.6 (95% CI, 1.9-4.2) months.
- Median OS: 9.2 (95% CI, 1.7-15.1) months.
- In MET amplification testing of tumor tissue from 13 RAS and BRAF wild-type patients:
- Among 4 responders, 2 had MET amplification, 1 was nonamplified, 1 had insufficient tumor tissue available.
- Most common grade ≥3 adverse events included neutropenia (14.6%), skin toxicity (12.2%), fatigue (9.8%), hypomagnesemia (4.9%), and fever (4.9%).
- Single-group study.