Seagen announces results from Phase 2 trial of ADCETRIS

Seagen announced results from two parts of a phase 2 trial evaluating ADCETRIS in combination with the PD-1 inhibitor nivolumab and standard chemotherapy agents doxorubicin and dacarbazine for the frontline treatment of patients with classical Hodgkin lymphoma. Part B of the trial evaluated patients with advanced-stage disease and was presented as an oral presentation, and Part C evaluated patients with early-stage disease and was presented as a poster at the 64th American Society of Hematology Annual Meeting and Exposition in New Orleans. Results demonstrated a complete response rate of 88% and an overall response rate of 93% in patients with advanced-stage disease and a CR rate of 92% and an ORR of 95% in patients with early-stage disease. The data showed that the combination was well-tolerated, with no new safety signals observed. Part B Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Advanced Stage Classic Hodgkin Lymphoma: Part B of SGN35-027 is evaluating the novel ADCETRIS combination in 57 patients with advanced-stage cHL. Results showed: An 88% CR rate and 93% ORR at the end of treatment.The estimated 12-month progression-free survival rate was 95%. The most frequently reported treatment-related treatment-emergent adverse events occurring in more than 40% of patients were nausea at 65%, fatigue at 47% and peripheral sensory neuropathy at 44%. Peripheral sensory neuropathy was primarily low grade, and no patients discontinued due to peripheral sensory neuropathy. Part C Phase 2 Study of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Early-Stage Classic Hodgkin Lymphoma. Part C of SGN35-027 is evaluating the novel ADCETRIS combination in 125 patients with early-stage cHL. Of 125 patients in the study, 76 were included at the time of efficacy assessment. Results showed: A 92% CR rate and a 95% ORR at end of treatment. Follow up is ongoing and PFS results are not yet available. The most frequently reported treatment-related TEAEs occurring in more than 30% of patients were nausea at 68%, peripheral sensory neuropathy at 42%, and fatigue at 38%/ Peripheral sensory neuropathy was primarily low grade, and no patients discontinued due to peripheral sensory neuropathy