Effectiveness of Loncastuximab Tesirine versus Idelalisib in FL

• Research type

  Research Study

• Full title

  A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

• IRAS ID

  1003466

• Contact name

  Sabine Soldan

• Sponsor organisation

  ADC Therapeutics SA

• Eudract number

  2020-003695-40

• Research summary

  Research Summary

  This study will take place globally and will involve approximately 150 male and female participants 18 years of age and older who have lymphoma which has worsened after treatment or has not responded to treatment (relapsed or refractory follicular lymphoma).

  This study will investigate whether the medication loncastuximab tesirine may be a more effective treatment for relapsed or refractory follicular lymphoma than treatment with the medication idelalisib. Loncastuximab tesirine is an antibody drug conjugate (ADC), which is a type of medication that combines an antibody (a protein that binds to specific substances in the body) with a chemotherapy medication that has the ability to kill cells. The antibody part of the medication helps direct the chemotherapy to cancer cells, or cells that help your cancer grow, and kill them. Idelalisib (ZYDELIG®) is approved by the US FDA and the European Medicines Agency (EMA) for use in follicular lymphoma when the disease worsens after two prior medication treatments.

  For each participant, the study includes a screening period (up to 28 days), a treatment period (cycles of 3/4 weeks), and a follow-up period (up to 3 years after the end of treatment). Participants will be randomly assigned to either loncastuximab tesirine or idelalisib. Twice as many participants will be assigned to treatment with loncastuximab tesirine as will be assigned to treatment with idelalisib. Participants assigned to loncastuximab tesirine treatment will receive one loncastuximab tesirine infusion through the vein every 3 weeks. Participants assigned to idelalisib treatment will take an idelalisib tablet by mouth twice a day every day. The duration of the treatment period depends on how well the participant tolerates the study medication and how their cancer responds to the treatment.

  Participants will undergo study procedures such as physical examinations, sample collection, ECGs and PET-CT/CT or MRI scans.

  Summary of Results

  Due to the early study termination and limited data, efficacy, and overall safety profile of loncastuximab tesirine compared to idelalisib could not be analysed; therefore, this study could not report any conclusions.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0062

• Date of REC Opinion

  16 Apr 2021

• REC opinion

  Further Information Favourable Opinion