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Nivolumab/Brentuximab Vedotin in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma

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Key Points

  • The objective response rate was 73%, with complete remission occurring in 37% of patients.
  • Median duration of response was not reached at the time of analysis.

As reported in the Journal of Clinical Oncology by Zinzani et al, findings in a phase II expansion cohort of the CheckMate 436 study indicated high levels of activity with the combination of nivolumab and brentuximab vedotin in relapsed or refractory primary mediastinal large B-cell lymphoma. As noted by the investigators, primary mediastinal large B-cell lymphoma is characterized by high expression of programmed cell death ligand 1 and variable expression of CD30.

In the multicenter, multicohort study, 30 evaluable patients received nivolumab at 240 mg and brentuximab vedotin at 1.8 mg/kg every 3 weeks until disease progression or unacceptable toxicity. Patients had received prior autologous hematopoietic cell transplantation or two or more prior chemotherapy regimens if ineligible for transplantation.

Response Rates

Median follow-up was 11.1 months. On investigator assessment, objective responses by Lugano 2014 criteria were observed in 22 patients (73%), with complete remission in 11 (37%). Stable disease was observed in an additional 3 patients (10%). On independent central review, the objective response rate was 70%, with a complete metabolic response rate of 43%.

Median time to first objective response was 1.3 months, and median time to complete response was 3.2 months. At the time of analysis, median duration of response and median progression-free and overall survival had not been reached. At 6 months, progression-free survival was 63.5% and overall survival was 86.3%. Among responders, 11 underwent consolidation with autologous (n = 5) or allogeneic (n = 6) transplantation.

Adverse Events

Treatment-related adverse events of any grade occurred in 25 patients (83%). Treatment-related grade 3 or 4 adverse events occurred in 16 patients (53%), with the most common being neutropenia (30%), thrombocytopenia (10%), and peripheral neuropathy (10%). No treatment-related deaths were reported.

The investigators concluded, “In patients with [relapsed or refractory] primary mediastinal large B-cell lymphoma, the combination of nivolumab plus [brentuximab vedotin] represents a promising option, with high antitumor activity and a manageable safety profile.”

Pier Luigi Zinzani, MD, PhD, of the Institute of Hematology, University of Bologna, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Bristol-Myers Squibb and Seattle Genetics. For full disclosures of the study authors, visit jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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