Allogeneic Transplant Following Brentuximab Vedotin Treatment in Patients with Relapsed or Refractory CD30+ Lymphomas Illidge T et al. Proc ASH 2011;Abstract.

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Allogeneic Transplant Following Brentuximab Vedotin Treatment in Patients with Relapsed or Refractory CD30+ Lymphomas Illidge T et al. Proc ASH 2011;Abstract 3091.

Illidge T et al. Proc ASH 2011;Abstract Background Allogeneic stem cell transplantation (allo-SCT) is an available treatment option for relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), though its exact role is unclear. Two phase II trials have evaluated brentuximab vedotin (B-vedotin), an anti-CD30 antibody-drug conjugate, in patients with relapsed or refractory CD30+ lymphomas: - HL: 75% ORR, 34% CR (Proc ASCO 2011;Abstract 8031) - sALCL: 86% ORR, 57% CR (Proc ASCO 2011;Abstract 8032) Current Study Objective: To retrospectively characterize the outcome of patients with HL and sALCL who received allo-SCTs after treatment with B-vedotin in the 2 Phase II trials.

Baseline Characteristics CharacteristicN = 15 HL8 sALCL7 Refractory to front-line therapy9 (60%) Refractory to most recent therapy4 (27%) Received a previous ASCT12 (80%) Prior chemotherapy regimens, median (range) 3 (2-5) ALK-positive (sALCL only)6 (40%) Illidge T et al. Proc ASH 2011;Abstract Fifteen patients of 160 total in the 2 Phase II trials received allo-SCT as their first therapy subsequent to treatment with B-vedotin.

Clinical Responses of Patients Receiving B-Vedotin and Allo-SCT Response, n (%) HL n = 7 sALCL n = 8 Total n = 15 Objective responses7 (100)8 (100)15 (100) Complete remission5 (71)7 (88)12 (80) Partial remission2 (29)1 (12)3 (20) Illidge T et al. Proc ASH 2011;Abstract 3091.

Progression-Free and Overall Survival (Median Follow-Up 19.6 Months) With permission from Illidge T et al. Proc ASH 2011;Abstract Five patients (1 with HL, 4 with sALCL) have progressed or died post allo-SCT. –Of the 2 deaths (both patients with sALCL who had a CR with B-vedotin), 1 was disease-related and the other due to transplant-related complications. Percentage of Subjects Alive Time From First Dose of B-Vedotin (Months) * Calculated from first dose of B-vedotin * Median not reached PFS OS

Maximum Tumor Reduction with B-Vedotin Prior to Allo-SCT With permission from Illidge T et al. Proc ASH 2011;Abstract Tumor Size (% Change from Baseline) Individual Patients (n = 15) Complete Response Partial Response

Adverse Events in 25% Patients (N = 15) Adverse eventAll gradesGrade 3 Peripheral sensory neuropathy53%13% Pyrexia53% Diarrhea47%7% Neutropenia33%7% Nausea33% Chills27% Dyspnea27%7% Other Grade 3 or 4 events in >2 patients: Anemia (20%) and thrombocytopenia (20%) Illidge T et al. Proc ASH 2011;Abstract 3091.

Author Conclusions Treatment with B-vedotin may be an option for reducing tumor burden to facilitate a consolidative allo-SCT in patients with relapsed or refractory HL or sALCL. Despite adverse risk factors, 10 of 15 patients (67%) in this case series remain in remission following treatment with B-vedotin and subsequent allo-SCT. After a median duration of follow-up of 19.6 months, the median PFS and OS for patients who received an allo-SCT after B-vedotin treatment has not yet been reached. Illidge T et al. Proc ASH 2011;Abstract 3091.

Investigator Commentary: Allogeneic Transplant Following B-Vedotin in Relapsed or Refractory CD30+ Lymphomas In this Phase II trial that I am part of, patients with HL and sALCL who achieved a remission were allowed to be taken off study and taken to transplant. Two out of 3 patients with HL that I have treated have been cured. One patient with sALCL achieved a remission but died because of complications from the transplant. Hence, decisions must be made cautiously. On the flip side, I treated a 62-year-old patient for whom an autologous transplant failed. She was not likely to receive an allogeneic transplant, so I started B-vedotin for her as part of the open-label study. I will keep her on B-vedotin until she has side effects. Another presentation at ASH showed no added toxicity in patients on extended treatment with B-vedotin. You can envision having a patient who responds to B-vedotin and will not be transplant eligible or does not want a transplant for whom you likely will recommend a treatment strategy by which you will administer this drug indefinitely while adjusting the dose. Interview with Craig Moskowitz, MD, January 11, 2012