SEATTLE GENETICS PRESENTS RESULTS OF NHL TRIAL

Seattle Genetics has announced positive data from a Phase I trial of its lead product candidate, SGN-40, demonstrating that it exhibits durable objective responses and is well-tolerated in patients with non-Hodgkin's lymphoma (NHL) who have failed multiple prior therapies. Another Phase I study showed SGN-40 induces antitumor activity and is well tolerated, and a maximum tolerated dose has not been reached in patients with relapsed multiple myeloma. The data were reported at the American Society of Hematology annual meeting.

In a single-arm, dose-escalation study, 35 patients have been enrolled with various subtypes of NHL, including diffuse large B-cell, follicular, mantle cell, marginal zone and small lymphocytic lymphomas. The median number of prior therapies per patient was 3.5. Out of 31 evaluable patients, five had measurable objective responses, including one complete response ongoing after 41 weeks. Four patients achieved partial responses, three of which are ongoing with durations of 10, 18 and 31 weeks. Eight additional patients had stable disease at the end of treatment. Notably, of the five responses, three were in patients with diffuse large B-cell lymphoma, an aggressive subtype of NHL.

SGN-40 was well tolerated using a dose-loading schedule. No dose-limiting toxicities or immunogenicity were identified, and adverse events were consistent with antibody administration, including fatigue and headache.

The company plans to initiate a single-agent Phase II clinical trial of SGN-40 in patients with diffuse large B-cell lymphoma to further investigate its utility in the relapsed or refractory patient population.

SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is highly expressed on most B lineage hematologic malignancies including NHL, multiple myeloma and chronic lymphocytic leukemia. CD40 is also found on many types of solid tumors, including bladder, renal and ovarian cancer, and may also play a role in immunologic diseases. In addition to relapsed/refractory NHL, SGN-40 is undergoing Phase I clinical trials for multiple myeloma and chronic lymphocytic leukemia.