Seagen's Adcetris/Immunotherapy Combo Achieves 98% Overall Response Rate in Early-Stage Lymphoma Setting

Seagen Inc SGEN announced updated efficacy and safety results from Part C of phase 2 single-arm trial of Adcetris (brentuximab vedotin) combined with nivolumab and standard chemotherapy agents doxorubicin & dacarbazine (AN+AD) for the frontline treatment of patients with early-stage classical Hodgkin lymphoma. 

Adcetris + AVD chemotherapy (Adriamycin, vinblastine, dacarbazine) is a U.S. standard of care in advanced-stage cHL based on national treatment guidelines. The data has shown that the regimen has a statistically significant overall survival benefit at six years of follow-up, reducing the risk of death by 41% for these patients.

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Adcetris is approved for seven indications in the U.S. and five in Europe, where Takeda Pharmaceutical Co Ltd TAK has commercialization rights.

Of 154 patients with early-stage disease in Part C of the study, 150 were included at the time of efficacy assessment, showing:

A 98% ORR and a 93% CR rate at the end of treatment.

Follow-up is ongoing, and progression-free survival (PFS) results are not yet available.

The most frequently reported treatment-related treatment-emergent adverse events (TRAEs) of any grade occurring in more than 30% of patients were nausea (65%), peripheral sensory neuropathy (47%), and fatigue (44%).

Peripheral sensory neuropathy was primarily low-grade. There were no cases of febrile neutropenia.

Updated data results from Part B of the study in patients with advanced-stage disease (n=57) were presented at the European Hematology Association 2023 Congress, which showed an estimated 95% 12-month PFS rate and 93% 18-month PFS rate, an ORR of 95% and CR rate of 89%. 

Price Action: SGEN shares are down 0.23% at $197.61 on the last check Tuesday.