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2023-09-25T14:39:57.000Z

SLS009 exhibits favorable data in R/R lymphomas: topline results from phase I dose escalation trial.

Sep 25, 2023
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma.

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Topline results obtained from a phase I dose escalation trial (NCT04588922) show that primary and secondary endpoints in safety, clinical activity, pharmacokinetics, and pharmacodynamics were met in patients with relapsed/refractory (R/R) lymphomas.1 These results indicate that SLS009 (formerly GFH009) may be a safe and efficacious treatment option for this patient population.1

Key findings1

A total of 52 R/R patients with lymphoma were enrolled and 34 patients were evaluable for efficacy. In this population:

  • In total, 14.7% achieved a clinical response, with a reduction in tumor burden of up to 62%.
  • Seven patients (20.6%) achieved stable disease, leading to an overall disease control rate of 35.3%.
  • Among the patients who had peripheral T-cell lymphoma, four out of 11 patients (36.4%) achieved clinical response.

No patients had unexpected toxicities and the drug was well tolerated, with no drug-related deaths reported at any dose level.

  • Patients receiving once-weekly infusions had ≥Grade 3 treatment-related adverse events which occurred at higher dose regimens.
  • Non-hematologic toxicities occurred in five patients (9.6%), of whom 5.8% experienced hypokalemia, 1.9% experienced upper respiratory tract infection, and 1.9% experienced increase in bilirubin.
  • Maximum tolerated dose was not reached.

The topline data from this phase I dose-escalation trial have led to a phase II clinical study. This study will assess SLS009 in patients with peripheral T-cell lymphoma, further elucidating the potential of this treatment for those with hematologic malignancies who have exhausted previous treatment options.1

  1. BioSpace.  SELLAS announces positive topline data in lymphoma cohort from SLS009 phase 1 dose-escalation trial, supporting advancement to phase 2 clinical study; primary and secondary endpoints met. https://www.biospace.com/article/releases/sellas-announces-positive-topline-data-in-lymphoma-cohort-from-sls009-phase-1-dose-escalation-trial-supporting-advancement-to-phase-2-clinical-study-primary-and-secondary-endpoints-met/. Published Sep 21, 2023. Accessed Sep 22, 2023.

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