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Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter,

Richard D Carvajal1, Sophie Piperno-Neumann1, Ellen Kapiteijn1

  • 1Richard D. Carvajal and Gary K. Schwartz, Columbia University Medical Center; Paul B. Chapman and Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center, New York, NY; Sophie Piperno-Neumann and Manuel J. Rodrigues, Institut Curie, Paris; Lauris Gastaud, Centre Antoine-Lacassagne, Nice, France; Ellen Kapiteijn, Leiden University Medical Center, Leiden, the Netherlands; Stephen Frank, Hebrew University Hadassah Medical School - The Sharett Institute of Oncology, Jerusalem; Jacob Schachter, Sheba Medical Center at Tel Hashomer, and Tel-Aviv University Medical School, Tel Aviv, Israel; Anthony M. Joshua, Princess Margaret Cancer Centre, Toronto, ON, Canada; Josep M. Piulats, Institut Catala d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain; Pascal Wolter, University Hospitals Leuven, Leuven, Belgium; Veronique Cocquyt, Ghent University Hospital, Ghent, Belgium; Bartosz Chmielowski, University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA; T.R. Jeffry Evans, University of Glasgow, Glasgow; Delyth Clemett, Shirley Spratt, Susan Lovick, and Elaine Kilgour, AstraZeneca, Macclesfield; Dana Ghiorghiu and Gabriella Mariani, AstraZeneca, Cambridge; Paul Nathan, Mt Vernon Cancer Centre, Northwood, United Kingdom; Gerald Linette, Washington University School of Medicine, St Louis, MO; Carola Berking, University Hospital of Munich, Munich, Germany; Peter Barker, AstraZeneca, Gaithersburg, MD; and Zhongwu Lai, AstraZeneca, Waltham, MA.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|March 13, 2018
PubMed

Insights

Metastatic uveal melanoma lacks effective systemic treatments. The combination of selumetinib (a MEK1/2 inhibitor) plus dacarbazine showed a tolerable safety profile but did not significantly improve progression-free survival compared to placebo plus dacarbazine.

Area of Science:

  • Oncology
  • Medical Treatments

Background:

  • Uveal melanoma is the most common primary intraocular malignancy in adults.
  • Currently, there are no effective systemic treatment options for metastatic uveal melanoma.

Purpose of the Study:

  • To evaluate the efficacy and safety of selumetinib plus dacarbazine versus placebo plus dacarbazine in patients with metastatic uveal melanoma.

Main Methods:

  • A phase III, double-blind, randomized trial (SUMIT study) assigned patients with metastatic uveal melanoma to selumetinib plus dacarbazine or placebo plus dacarbazine (3:1 ratio).
  • The primary endpoint was progression-free survival (PFS) assessed by blinded independent central radiologic review.
  • Secondary endpoints included overall survival and objective response rate.

Main Results:

  • 129 patients were randomized. Median PFS was 2.8 months for selumetinib plus dacarbazine versus 1.8 months for placebo plus dacarbazine (HR, 0.78; P = .32).
  • The objective response rate was 3% with selumetinib plus dacarbazine and 0% with placebo plus dacarbazine (P = .36).
  • Overall survival analysis showed a hazard ratio of 0.75 (P = .40). Common adverse events included nausea, rash, fatigue, diarrhea, and peripheral edema.

Conclusions:

  • The combination of selumetinib plus dacarbazine demonstrated a tolerable safety profile in patients with metastatic uveal melanoma.
  • However, this combination did not significantly improve progression-free survival compared to placebo plus dacarbazine.

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