ASH Clinical News September 2015 | Page 33

CLINICAL NEWS The U.S. FDA approved brentuximab vedotin for the post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression. The approval was based on the results of a randomized, double-blind, placebo-controlled trial that included 329 patients with classical Hodgkin lymphoma. After auto-HSCT, patients were randomized 1:1 to receive brentux- fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea. The most commonly reported serious adverse events included pneumonia, pyrexia, vomiting, nausea, hepatotoxicity, and peripheral sensory neuropathy. Of the patients in the brentuximab vedotin group, infusion-related reactions were reported in 15 percent of patients (n=25) and pulmonary toxicity was reported in five percent of patients (n=8). imab vedotin or placebo once every three weeks for a maximum of 16 cycles. The median progression-free survival in the brentuximab vedotin cohort was 42.9 months, compared with 24.1 months in the control group (hazard ratio=0.57; 95% CI 0.40-0.81; p=0.001). The most commonly reported treatment-associated adverse events for the brentuximab vedotin group were neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, Source: U.S. FDA press release First Study to Show T-Cell Therapy Response in Multiple Myeloma A new study published in Nature Medicine indicated that T-cell receptor therapy using a patient’s own immune system to recognize and destroy cancer T:7” Table 4: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms* All Adverse Reactionsa Table 4: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms* Grade 3/4 Adverse Reactionsb Grade 3/4 Adverse Reactionsb All Adverse Reactionsa Rd Rd System organ class Continuous Rd18 MPT Continuous Rd18 MPT Preferred term (N = 532) (N = 540) (N = 541) (N = 532) (N = 540) (N = 541) Rd Rd System organ class Continuous Rd18 MPT Continuous Rd18 MPT Preferred term (N = 532) (N = 540) (N = 541) (N = 532) (N = 540) (N = 541)