This single-arm trial enrolled 36 patients with relapsed or refractory multiple myeloma who received escalating doses of dacetuzumab ranging from 4 mg/kg to 12 mg/kg in combination with Revlimid and weekly dexamethasone. Patients had a median age of 64.5 years and had received a median of four prior cancer-related therapies. Fifty percent of patients had received prior Revlimid.

The combination was generally well-tolerated and no maximum tolerated dose was identified. The majority of adverse events were Grade 1 or 2 in severity. The most common adverse events were fatigue, neutropenia, and thrombocytopenia. Objective responses were achieved in 44 percent of patients (16 out of 36 patients), including two complete responses and 14 partial responses. The objective response rate was 61 percent for patients who were Revlimid-na ve and 28 percent for those who had previously received Revlimid. (Abstract # 2870)

Dacetuzumab Gene Signature

Data were presented describing a diagnostic gene signature that may identify lymphoma patients who are more likely to respond to dacetuzumab therapy. In a retrospective analysis of patient samples from single-agent phase I and phase II trials, the data demonstrate that the gene signature correlated with sensitivity to treatment with dacetuzumab with an overall accuracy of 80 percent. In addition, patients predicted to respond to dacetuzumab therapy exhibited a longer progression-free survival than patients who did not express the gene signature. (Abstract # 2721)

seagen/