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A Phase Ib/II Study of Ramucirumab in Combination with Emibetuzumab in Patients with Advanced Cancer

James J Harding1,2, Andrew X Zhu3, Todd M Bauer4

  • 1Memorial Sloan Kettering Cancer Center, New York, New York. hardinj1@mskcc.org.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|May 31, 2019
PubMed
Abstract

Insights

This study combined ramucirumab and emibetuzumab, showing cytostatic antitumor activity. High MET expression in hepatocellular carcinoma patients indicated better progression-free survival, suggesting targeted patient selection.

Area of Science:

  • Oncology
  • Translational Research
  • Immunotherapy

Background:

  • Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) inhibition blocks tumor angiogenesis.
  • Cancer cells can develop resistance to VEGFR-2 inhibitors via activation of the hepatocyte growth factor receptor MET.
  • Combination therapies targeting both VEGFR-2 and MET pathways are being investigated to overcome resistance.

Purpose of the Study:

  • To evaluate the safety and efficacy of combining ramucirumab (anti-VEGFR-2 antibody) with emibetuzumab (anti-MET monoclonal antibody) in patients with solid tumors.
  • To determine the recommended Phase II dose for this combination therapy.
  • To explore the role of tumoral MET expression in predicting patient response.

Main Methods:

  • A Phase Ib/II study involving dose escalation (Phase Ib) and expansion cohorts.
  • 97 patients with various solid tumors received emibetuzumab and ramucirumab.
  • Tumoral MET expression was assessed using immunohistochemistry (IHC).

Main Results:

  • The combination was safe with no dose-limiting toxicities; common adverse events were mild to moderate.
  • Overall response rate was 5.2%, with notable activity in hepatocellular carcinoma (HCC).
  • In HCC patients, high MET expression correlated with a 3-fold increase in progression-free survival (PFS) compared to low MET expression.

Conclusions:

  • Ramucirumab plus emibetuzumab demonstrated safety and cytostatic antitumor activity.
  • MET expression levels can potentially identify patients who may benefit most from this combination therapy in specific cancer types.
  • This combination warrants further investigation for targeted cancer treatment strategies.

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