What are ADC's

Our services

ADC Review
is made possible by:


Study Title
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) (NCT01100502)

Trial Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

This trial is sponsored by Seattle Genetics/Millennium Pharmaceuticals. [1]

Study Data

  • Condition: Lymphoma
  • Interventions:
  • Phase: III
  • Enrollment: 329
  • Start: April 2010
  • Estimated Completion: April 2016
  • Last verified: March 2015
  • Last updated: April 12, 2016
  • Health Authority: United States Food and Drug Administration (FDA)

Study Schematic 

Fig 1.0: The AETHERA Trial is a Phase III Study of Brentuximab Vedotin, also known as SGN-35, in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant. PFS follow-up (year 2) included continued monitoring with scans at 18 and 24 months and quarterly clinical assessments. Patients in this trial who experienced disease progression per investigator during the study were unblinded and could receive brentuximab vedotin as part of a separate trial.

Trial Results
The AETHERA trial is a randomized, double-blind, phase III study of brentuximab vedotin and best supportive care (BSC) vs. placebo and BSC in Hodgkin lymphoma (HL) patients at increased risk of relapse or progression post-autologous stem cell transplant (ASCT). Early consolidation post-ASCT with brentuximab vedotin demonstrated improved progression-free survival (PFS) per independent review compared with placebo (median PFS 43 vs 24 months; HR = 0.57, p = 0.001). The most common treatment-emergent grade ≥3 adverse events (AEs) were neutropenia (29% brentuximab vedotin vs 10% placebo), peripheral sensory neuropathy (10% vs 1%), thrombocytopenia (4% vs 3%), peripheral motor neuropathy (6% vs 1%) and anaemia (4% vs 2%). Treatment discontinuation due to AEs occurred in 33% vs 6% of patients, and 53 patients died on study (17% vs 16%). [2]

Last Editorial review: June 10, 2016
Information based on (NIH/NCI) and other sources.

Copyright © 2015 – 2016 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Add to Flipboard Magazine.


Recommended Articles

Four Ways to Show Nonobviousness of ADC Inventions

05 October, 2018

When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000,[1] only a handful of patent applications claiming ADCs had been published.[2] As research cont...

Skip to toolbar