mCRC: tivantinib+cetuximab fails in anti-EGFR, MET-high patients

  • Rimassa L, et al.
  • Clin Colorectal Cancer
  • 4 Feb 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Single-group study. 

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