(B-Cell Lymphoma) Is Opdivo + Adcetris Effective?

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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