All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
  TRANSLATE

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact

Loncastuximab tesirine receives positive CHMP opinion for the treatment of patients with R/R DLBCL

Sep 20, 2022
Share:
Learning objective: After reading this article, learners will be able to cite a new clinical development in R/R DLBCL.

On September 16, 2022, it was announced that loncastuximab tesirine received a positive opinion in Europe from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).1

The approval was based on the supporting results from the phase II LOTIS-2 trial (NCT03589469).1

Loncastuximab tesirine is a CD19-targeted antibody and alkylating agent conjugate designed to target and destroy CD19-expressing malignant B cells.1

LOTIS-2 is a single-arm, multicenter trial in 145 adult patients with R/R DLBCL who received ≥2 prior lines of systemic therapy. The study included heavily pretreated patients with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple-hit genetics, and patients who had a stem cell transplant and chimeric antigen receptor (CAR) T-cell therapy prior to their treatment.2 The study showed that loncastuximab tesirine produces positive responses (an overall response rate of 48.3% and a complete response rate of 24.1%) in heavily pretreated patients with R/R DLBCL. The median duration of response was 10.3 months. The most common Grade ≥3 treatment-emergent adverse events reported in ≥10% of patients were neutropenia (26.2%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (17.2%), and anemia (10.3%).2

This positive CHMP opinion is now referred to the European Commission for approval—a decision is expected later this year.1

Prior to this, on April 23, 2021, the U.S. Food and Drug Administration (FDA) issued an accelerated approval for loncastuximab tesirine for the treatment of adult patients with R/R DLBCL who have had ≥2 prior lines of therapy.2

  1. Business Wire. ADC Therapeutics and Sobi announce ZYNLONTA® (loncastuximab tesirine) receives positive CHMP opinion in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma. https://www.businesswire.com/news/home/20220916005045/en/ADC-Therapeutics-and-Sobi-Announce-ZYNLONTA%C2%AE-loncastuximab-tesirine-Receives-Positive-CHMP-Opinion-in-Europe-for-the-Treatment-of-Relapsed-or-Refractory-Diffuse-Large-B-cell-Lymphoma. Published Sep 16, 2022. Accessed Sep 20, 2022.
  2.  ADC Therapeutics announces FDA approval of ZYNLONTA™ (loncastuximab tesirine-lpyl) in relapsed or refractory diffuse large B-cell lymphoma. https://www.businesswire.com/news/home/20210423005537/en/ADC-Therapeutics-Announces-FDA-Approval-of-ZYNLONTA%E2%84%A2-loncastuximab-tesirine-lpyl-in-Relapsed-or-Refractory-Diffuse-Large-B-Cell-Lymphoma. Published Apr 23, 2021. Accessed Sep 20, 2022.