(B-Cell Lymphoma) Is Opdivo + Adcetris Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
From June 13 to 16, 2019, Pier Luigi Zinzani presented at the European Hematology Association (EHA) conference in Amsterdam, Netherlands, the "Efficacy and Safety Evaluation of Combined Anti-PD-1 Antibody Opdivo (nivolumab) Plus Anti-CD30 Antibody Adcetris (brentuximab vedotin) in CD30-Positive Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBL) in the CheckMate 436 Phase II Clinical Trial."
The CheckMate 436 trial was an international multicenter open-label trial administering combined Opdivo + Adcetris therapy (every 3 weeks: Opdivo 240mg + Adcetris 1.8mg/kg) to patients with CD30-positive relapsed or refractory primary mediastinal B-cell lymphoma. The primary endpoint was objective response rate, and secondary endpoints included progression-free survival and overall survival.
The trial enrolled 30 patients with the following characteristics:
- Median age: 35.5 years (range 19-83)
- Median number of prior treatment regimens: 2 (range 2-5)
- Prior hematopoietic stem cell transplant: 13% (N=4)
The primary endpoint objective response rate was 73%, with complete response at 37% (N=11). Among 25 evaluable patients, 13 patients showed target lesion reduction of 50% or more.
Regarding safety, the most commonly observed adverse events were neutropenia (30%), peripheral neuropathy (27%), peripheral sensory neuropathy (13%), thrombocytopenia (13%), skin lesions (13%), and hyperthyroidism (13%).
The most commonly observed serious adverse events were neutropenia (30%), thrombocytopenia (10%), peripheral neuropathy (27%), febrile neutropenia (7%), hypersensitivity (3%), ulcerative colitis (3%), rash (3%), maculopapular rash (3%), and autoimmune hepatitis (3%).
Based on the CheckMate 436 trial results, Pier Luigi Zinzani concluded: "Combined anti-PD-1 antibody Opdivo plus anti-CD30 antibody Adcetris achieved an objective response rate of 73% in CD30-positive relapsed or refractory primary mediastinal large B-cell lymphoma (PMBL). The safety profile was consistent with data from other clinical trials, and patients were able to tolerate the adverse events."
Source: NIVOLUMAB COMBINED WITH BRENTUXIMAB VEDOTIN FOR RELAPSED/REFRACTORY PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA: EFFICACY AND SAFETY RESULTS FROM THE PHASE 2 CHECKMATE 436 STUDY. (2019 EHA, Abstract No: S1601)
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