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).
- 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.