8:32AM Seattle Genetics highlights ADCETRIS Phase 2 Clinical data in diffuse large B-cell lymphoma; 42% objective response rate in relapsed or refractory DLBCL (SGEN) 41.16 : Co announces updated results from a phase 2 clinical trial of ADCETRIS in diffuse large B-cell lymphoma and other B-cell non-Hodgkin lymphomas. ADCETRIS is an antibody-drug conjugate directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL or other B-cell lymphomas.
A Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas: Interim Results in Patients with DLBCL and Other B-cell Lymphomas
Interim data from an ongoing phase 2 clinical trial were reported from 50 patients with DLBCL and 18 patients with other B-cell lymphomas. Among the DLBCL patients, the median age was 63 years, 74% were refractory to frontline therapy and 82% were refractory to their most recent prior therapy. Patients were treated with single-agent ADCETRIS every three weeks. The trial was designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients.
Key findings presented included:
Of the 50 patients with DLBCL, 42% achieved an objective response, including 16% complete remissions and 26% partial remissions.
At the time of data analysis, the median duration of response for DLBCL was 5.8 months. For DLBCL patients who achieved a complete remission, the median duration of response was 11.5 months.
Objective responses were observed across a broad range of CD30 expression, from DLBCL patients with undetectable CD30 by standard immunohistochemistry testing to those with CD30 expression up to 90%.
The most common treatment-emergent adverse events of any grade in patients with DLBCL and other B-cell lymphomas occurring in more than 25% of all patients enrolled were fatigue (49%), neutropenia (40%), nausea (38%), diarrhea (37%) and fever (29%).
The most common Grade 3 treatment-emergent adverse events in patients with DLBCL and other B-cell lymphomas were neutropenia and anemia. The only Grade 4 treatment-emergent event was neutropenia. Serious adverse events considered related to treatment and occurring in more than one patient were pneumonia (three patients) and anemia, febrile neutropenia, neutropenia and thrombocytopenia (two patients each).
