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The use of immune checkpoint inhibitors (ICIs) in treating cancer has greatly improved survival outcomes, particularly in patients with advanced disease for whom successful treatment options have previously been limited. For example, in patients with metastatic melanoma, the median survival time has improved from just 6 months to approximately 6 years with the use of […]

Victoria P. Werth, ACR 2022: The phase 3 DeterMine trial of lenabasum in dermatomyositis

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Published Online: Jan 4th 2023

DeterMine (NCT03813160) was a phase 3 randomized, double-blind, placebo-controlled study investigating the efficacy and safety of lenabasum for the treatment of dermatomyositis. It was a pleasure to talk with Prof. Victoria P. Werth (University of Pennsylvania, Philadelphia, PA, USA) to discuss the aims, design, eligibility criteria and findings of the phase 3 study.

This information is brought to you by Touch Medical Media and is not sponsored by, nor a part of, the American College of Rheumatology.

The abstract ‘Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis.‘ (Abstract number: 0173) was presented at the ACR Convergence, November 10–14, 2022.

Questions

  1. Could you tell us a little about dermatomyositis and the unmet needs in its treatment? (0:16)
  2. What is lenabasum and what is the rationale for its use in this indication? (2:38)
  3. What were the aims, design and eligibility criteria of your phase 3 study? (3:29)
  4. What were the primary and secondary outcome measures and how well were they achieved? (5:49)
  5. Why do you think these endpoints were not met, and what were the positive outcomes of this study? (7:26)

Disclosures: Victoria P. Werth discloses receiving grants from: Celgene, Amgen, Janssen, Biogen, Gilead, Viela, Horizon therapeutics, and Ventus; consulting for: Astra-Zeneca, Pfizer, Biogen, Celgene, Resolve, Janssen, Gilead, Lilly, BMS, Nektar, Abbvie, Viela, GSK, EMD Serona, Sanofi, Anaptysbio, Amgen, Merck Kyowa Kirin, Rome Therapeutics, and Xencor; serving on advisory boards for: Lupus Foundation of America; and receiving honorarium from: Astra-Zeneca, Pfizer, Biogen, Celgene, Resolve, Janssen, Gilead, Lilly, BMS, Nektar, Abbvie, Viela, GSK, EMD Serona, Sanofi, Anaptysbio, Amgen, Merck Kyowa Kirin, Rome Therapeutics, and Xencor.

Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.

Filmed in coverage of the ACR Convergence 2022.

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