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Published on 10 December 2014

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Takeda announces 4-year survival data from ADCETRIS® pivotal trial at ASH annual meeting

Takeda UK announced 4-year overall survival (OS) data from the ADCETRIS (brentuximab vedotin) pivotal Phase II clinical trial in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic ALCL, a type of T-cell lymphoma.

 

Takeda UK announced 4-year overall survival (OS) data from the ADCETRIS (brentuximab vedotin) pivotal Phase II clinical trial in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic ALCL, a type of T-cell lymphoma.

 

At a median follow up of 46.3 months, the estimated 4-year survival rate was 64%. (1) The data were presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Francisco, CA.

Professor Tim Illidge, Professor of Targeted Therapy and Oncology, University of Manchester, The Christie NHS Foundation Trust, and a UK trialist commented, “Patients with systemic anaplastic large cell lymphoma are highly treatment-refractory and historically difficult to treat, representing a significant unmet medical need. The 4-year follow-up of patients in the Phase II pivotal trial with brentuximab vedotin, demonstrates a step change in the clinical outcomes for these patients together with a manageable side effect profile. The overall response rates demonstrate that brentuximab vedotin appears to play a role in the long-term durable remission of some patients.

The data estimate that more than 60% of the relapsed or refractory ALCL patients treated with ADCETRIS in this study are alive at 4 years, which may positively redefine outcome expectations in this difficult to treat cancer,” said Dirk Huebner, MD, Senior Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “The fact that a third of all patients treated in the trial remain in complete remission with no evidence of disease after a median follow up of 46 months suggests the difference ADCETRIS can make in this disease.”

4-Year survival data from an on-going pivotal Phase II study of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (Abstract #3095)

A pivotal, single-arm clinical trial was conducted in 58 relapsed or refractory systemic ALCL patients to assess the efficacy and safety of single-agent brentuximab vedotin. In addition, the trial was designed to determine duration of response, progression-free survival (PFS) and overall survival (OS). Patients received 1.8mg/kg of brentuximab vedotin administered through a 30-minute intravenous infusion every 3 weeks for up to 16 cycles. As previously reported, 86% of patients on the trial achieved an objective response, including 59% with a complete response (CR) and 28% with a partial response (PR).

Barbara Pro, MD, Thomas Jefferson University highlighted data from long-term patient follow-up in this pivotal trial, and include:

  • After a median observation time of 46.3 months from the first dose of brentuximab vedotin, the median OS was 55.1 months and the estimated 4-year OS was 64%.
  • The median PFS per investigator was 20.0 months.
  • 19 of 38 patients (50%) who achieved a CR on study per investigator assessment remained in remission at the time of last follow-up; for all patients who achieved a CR, median OS and PFS had not yet been reached.
  • For the 16 CR patients who received a consolidative transplant (either allogeneic or autologous stem cell transplant), neither median PFS nor OS had been reached.
  • For the 22 CR patients who did not receive a consolidative transplant, median PFS was 39.4 months and median OS had not yet been reached. 8 CR patients remained in remission without receipt of any subsequent anti-lymphoma therapy following brentuximab vedotin.
  • The most common adverse events of any grade were peripheral neuropathy (57%), nausea (40%), fatigue (38%), pyrexia (34%) and diarrhoea (29%).
  • The most common Grade 3 or 4 adverse events occurring in at least 5% of patients were neutropenia (21%), peripheral neuropathy (17%), thrombocytopenia (14%), anaemia (7%) and recurrent ALCL (5%).

About Adcetris (brentuximab vedotin)
Brentuximab vedotin is an innovative antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Once inside the cell, the MMAE is released from the antibody and the cancer cell is destroyed. The innovative mechanism of action and precise cancer cell targeting means that patients generally cope better with the side effects. (2)

Brentuximab vedotin was granted a conditional licence in 2012 by the European Medicines Agency (EMA). A conditional licence is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk, despite the fact that additional data are still required. It is licenced for two indications:

  1. For the treatment of adult patients with relapsed or refractory CD30-positive HL following ASCT, or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
  2. For the treatment of adult patients with relapsed or refractory sALCL.

Further information on brentuximab vedotin can be found in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), which can be obtained at www.medicines.org.uk.

 

References:

  1. Pro et al. The Four-Year Survival Data from an Ongoing Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. Abstract No. 3095. American Society of Hematology, December 2014, San Francisco, CA, USA
  2. Adcetris Summary of Product Characteristics (SmPC). Available at: www.medicines.org.uk.


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