Data highlights from the long-term survival analysis in the pivotal trial were:
- After a median observation time of approximately 2.5 years from first dose of ADCETRIS, 59 percent of patients (60 of 102 patients) were alive and the median overall survival had not yet been reached.
- The estimated two year survival rate was 65 percent, including 91 percent for patients who achieved a complete remission.
- Improved overall survival and progression-free survival correlated with PET (positron emission tomography) evaluation at Cycle four.
- There was no significant difference in prolonged overall survival in patients whose disease progressed less than or more than one year following ASCT. The only pretreatment factor that was associated with a higher two year survival rate was a baseline ECOG score of 0.
- The most common adverse events of any grade were peripheral sensory neuropathy (47 percent), fatigue (46 percent), nausea (42 percent), upper respiratory tract infection (37 percent) and diarrhea (36 percent).
- Among the most common adverse events of any grade, the most common Grade 3 or 4 adverse events were neutropenia (14 percent Grade 3, 6 percent Grade 4) and peripheral sensory neuropathy (9 percent Grade 3). Other Grade 3 or 4 adverse events occurring in at least five percent of patients were thrombocytopenia (8 percent) and anemia (6 percent).
Overall Survival Benefit for Patients with Relapsed Hodgkin Lymphoma Treated with Brentuximab Vedotin After Autologous Stem Cell Transplant (Abstract #3701)
An independent retrospective comparison conducted by MD Anderson Cancer Center evaluated overall survival in 102 relapsed HL patients treated with ADCETRIS in a pivotal clinical trial compared to data from 756 relapsed HL patients treated at six international centers (Horning et al., 2008). The authors compared median overall survival, starting at the time of receiving an ASCT, among ADCETRIS treated patients to patients not treated with ADCETRIS. Key findings, which were highlighted in a presentation by Dr. Meghan Karuturi from MD Anderson Cancer Center, included:
- Median overall survival following the date of ASCT in ADCETRIS treated patients was 91.49 months compared to 27.99 months in those not treated with ADCETRIS (p<0.0001).
- In an analysis evaluating predictors of patients who achieved a durable complete remission with ADCETRIS, only the stage of disease at initial diagnosis had a significant effect on overall survival.
Brentuximab Vedotin as a First Line Salvage Therapy in Relapsed/Refractory HL (Abstract #3699)An investigator-sponsored trial was conducted to evaluate ADCETRIS as a salvage therapy for HL. Fourteen patients were evaluated for response and safety and all had relapsed or refractory HL after initial therapy with the chemotherapy regimens ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, Adriamycin, cyclophosphamide, Oncovin, procarbazine hydrochloride, prednisone) or a combination of chemotherapy with or without consolidative radiation treatment. Patients were treated with ADCETRIS every three weeks for a maximum of four cycles. Data were presented by Dr. Robert Chen from City of Hope National Medical Center in Duarte, CA.