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» Seattle Genetics Inc. Q1 2010 Earnings Call Transcript
» Seattle Genetics Inc. Q2 2009 Earnings Call Transcript
» Seattle Genetics Inc. Q1 2009 Earnings Call Transcript
I'll now turn the call over to Clay.Clay Siegall Thanks, Peg, and thank you all for joining us this afternoon. Our progress over the past two months has positioned Seattle Genetics for several important milestones over the remainder of 2010 and into 2011. We expect data from our two late-stage programs, brentuximab vedotin and lintuzumab, later this year. We're also making progress on several other clinical stage programs, including SGN-75 and ASG-5ME. And our antibody drug conjugate or ADC technology is continuing to generate value both financially and from the pipeline perspective. Today, I'll summarize our recent accomplishments and planned milestones. I'll start with an update on our lead product candidate, brentuximab vedotin, also known as SGN-35. This is an ADC targeting CD30, the defining marker for Hodgkin lymphoma and a target also highly expressed on several T-cell lymphomas, including anaplastic large cell lymphoma or ALCL. We expect to report top-line data from our pivotal trial in relapsed and refractory Hodgkin lymphoma in the late September to October timeframe. This trial is designed to provide the basis for an NDA in United States under the accelerated approval regulations and in MAA in Europe, both in the first half of 2011. This single-agent pivotal trial in 100 patients is being conducted under a Special Protocol Assessment with the FDA. Key endpoints include objective response rate assessed by independent review, complete response rate, duration of response and safety. We also expect to report interim top-line data from our phase II systemic ALCL trial in the late September to October timeframe. There is a substantial need for new therapies for ALCL, an aggressive type of T-cell non-Hodgkin lymphoma. During the second quarter, we achieved our target enrollment of 55 patients to this study. The ALCL trial has a design similar to our pivotal Hodgkin lymphoma trial, with the primary endpoint of objective response rate assessed by independent review. We believe that ALCL may provide an additional registration pathway for brentuximab vedotin.
At the American Society of Clinical Oncology meeting in June, we presented preliminary data from our experience in the retreatment of patients who relapsed after previously responding to brentuximab vedotin. We reported that tumor reduction was observed in 10 out of 11 retreatment experiences, seven of which were objective responses.Brentuximab vedotin was well tolerated in the retreatment setting. Treatment-related adverse events were all Grade 1 or 2 with peripheral neuropathy, alopecia, joint pain and injection site irritation the most commonly reported. We are continuing to evaluate the retreatment of patients with brentuximab vedotin through our ongoing phase II clinical trial. Data from that trial will identify if retreatment could be an additional option for managing relapsed Hodgkin lymphoma and other CD30-positive malignancies. The other two ongoing clinical trials with brentuximab vedotin include: first, the phase III AETHERA trial, which is designed to globally enroll 322 post-autologous transplant Hodgkin lymphoma patients who are at a high risk for residual disease. This study is evaluating whether brentuximab vedotin can extend progression-free survival in these patients. In addition, the AETHERA trial is intended to fulfill regulatory requirements for full approval in the United States and Europe. The second is a phase I clinical trial of brentuximab vedotin in combination with chemotherapy for the treatment of front-line Hodgkin lymphoma patients. We are assessing its safety in combination with ABVD, a standard chemotherapy regimen for front-line Hodgkin lymphoma. The trial will enroll approximately 40 newly diagnosed patients. Both the AETHERA trial and the front-line combination trial also highlight that we are looking beyond our initial focus of relapsed/refractory Hodgkin lymphoma and ALCL towards the potential of brentuximab vedotin in earlier lines of therapy. We're also considering trials in other CD30-positive malignancies. In addition to our clinical trials, we have substantial manufacturing and regulatory efforts ongoing and are continuing to build the sales and marketing infrastructure necessary for commercialization. These activities are all supportive of our ultimate goal of aggressively driving this program forward for patients with limited treatment options. Read the rest of this transcript for free on seekingalpha.com