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  • Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Phase 2 Clinical Data in Diffuse Large B-cell Lymphoma (DLBCL) at ASH 2013

    Seattle Genetics today announced updated results from a phase 2 clinical trial of ADCETRIS (brentuximab vedotin) in diffuse large B-cell lymphoma (DLBCL) and other B-cell non-Hodgkin lymphomas. The data, which demonstrated an encouraging activity and tolerability profile in the relapsed and refractory setting, were presented in an oral presentation at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL or other B-cell lymphomas.

    “In DLBCL, patients with relapsed or refractory disease have poor outcomes, and there is a significant need for better therapeutic approaches to treat this aggressive non-Hodgkin lymphoma subtype,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “We are encouraged by the interim phase 2 results which demonstrated that single-agent ADCETRIS induced a 42 percent objective response rate and manageable safety profile among advanced DLBCL patients, including a high percentage whose disease was refractory to their prior therapy. Based on these data, we have expanded our clinical program for ADCETRIS in DLBCL both as a single-agent and in combination with standard regimens for both relapsed and newly diagnosed patients.”

    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 (Abstract #848)

    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 percent were refractory to frontline therapy and 82 percent 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 by Dr. Nancy Bartlett from the Washington University, Siteman Cancer Center in St. Louis, MO, included:

    • Of the 50 patients with DLBCL, 42 percent achieved an objective response, including 16 percent complete remissions and 26 percent 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 percent.
    • The most common treatment-emergent adverse events of any grade in patients with DLBCL and other B-cell lymphomas occurring in more than 25 percent of all patients enrolled were fatigue (49 percent), neutropenia (40 percent), nausea (38 percent), diarrhea (37 percent) and fever (29 percent).
    • 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).

    These encouraging findings support Seattle Genetics’ ongoing evaluation of ADCETRIS as a treatment for DLBCL. The phase 2 clinical trial presented at ASH has been expanded to include a treatment arm to assess the activity and tolerability of ADCETRIS in combination with Rituxan (rituximab) as well as an arm to evaluate single-agent ADCETRIS in patients with undetectable CD30 expression using standard immunohistochemistry methods. In addition, a phase 2 trial was recently initiated to evaluate ADCETRIS plus R-CHOP in newly diagnosed, high-risk DLBCL patients, regardless of CD30 expression level. More information about these ongoing phase 2 DLBCL clinical trials, including enrolling centers, is available by visiting the clinical trials website.

    Published in: Seattle Genetics Website, December 10, 2013

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    Annual Resource Guide


  • Seattle Genetics Highlights Data from Broad ADCETRIS® (Brentuximab Vedotin) Development Program at ASH 2013

    Seattle Genetics today summarized ADCETRIS (brentuximab vedotin) data in Hodgkin lymphoma (HL) and non-Hodgkin lymphoma from multiple presentations at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. Highlights include encouraging interim data from a phase 2 clinical trial evaluating ADCETRIS as a single-agent for previously untreated HL patients age 60 or older and updated data from a phase 1 clinical trial of ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, commonly referred to as peripheral T-cell lymphoma (PTCL). In addition, data were presented from an investigator-sponsored phase 2 clinical trial evaluating ADCETRIS in relapsed cutaneous T-cell lymphoma (CTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of frontline HL, frontline MTCL or relapsed CTCL.

    “ADCETRIS is being evaluated broadly through more than 20 ongoing corporate and investigator-sponsored clinical trials in a variety of Hodgkin lymphoma and non-Hodgkin lymphoma disease settings,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “The interim data evaluating ADCETRIS as a treatment for older Hodgkin lymphoma patients are particularly encouraging, suggesting compelling activity and a manageable safety profile in a patient population that historically cannot tolerate conventional combination chemotherapy regimens and has inferior outcomes. In addition, updated data from trials evaluating ADCETRIS in both frontline mature T-cell lymphoma and cutaneous T-cell lymphoma provide strong rationale for the ongoing phase 3 ECHELON-2 and ALCANZA clinical trials.”

    Frontline Data Presentations

    A Phase 2 Study of Single-Agent Brentuximab Vedotin for Frontline Therapy of Hodgkin Lymphoma in Patients Age 60 Years and Above: Interim Results (Abstract #4389)

    Data were presented from an ongoing phase 2 clinical trial evaluating ADCETRIS as frontline therapy for patients age 60 or older with previously untreated HL. The data presented are from a trial that is designed to assess the activity and tolerability of ADCETRIS as a monotherapy for older HL patients who have received no prior treatment. Interim data were reported from 19 patients. The median age of patients was 78 years (range, 64 to 92). The data were highlighted in a poster presentation by Dr. Christopher Yasenchak from the Northwest Cancer Specialists in Tualatin, OR. The key findings included:

    • Of the 19 patients evaluable at the time of this analysis, 17 patients (89 percent) had an objective response, including 12 (63 percent) complete remissions and five (26 percent) partial remissions.
    • All 19 patients (100 percent) achieved tumor reduction as determined by best percentage change from baseline.
    • The median duration of treatment was 18 weeks (six cycles) at the time of analysis.
    • The most common treatment-emergent adverse events were Grade 1 or 2 and included peripheral sensory neuropathy (47 percent), fatigue (32 percent), diarrhea (26 percent), peripheral edema (26 percent), itching (26 percent), hair loss (21 percent), nausea (21 percent) and urinary tract infection (21 percent).
    • Grade 3 events occurring in one patient each included peripheral sensory neuropathy, rash, neutropenia and dizziness upon standing. No Grade 4 events were observed.

    Brentuximab Vedotin Administered Before, During, and After Multi-agent Chemotherapy in Patients with Newly-diagnosed CD30+ Mature T- and NK-cell Lymphomas (Abstract #4386)

    Data were presented from a phase 1 clinical trial evaluating ADCETRIS administered in combination with or sequentially with chemotherapy for the treatment of newly-diagnosed MTCL. Data were reported in 13 patients who received sequential treatment with two cycles of ADCETRIS followed by six cycles of the combination chemotherapy regimen CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) and 26 patients who received the combination regimen of ADCETRIS plus CHP (A+CHP), which removes vincristine (Oncovin). The median age of patients was 57 years. The data were highlighted in a poster presentation by Dr. Michelle Fanale from The University of Texas MD Anderson Cancer Center.

    Updated key findings for ADCETRIS in combination with CHP included:

    • Of 26 patients receiving the combination regimen, 23 (88 percent) received all six cycles of initial treatment with A+CHP. Twenty-one patients received maintenance treatment with single-agent ADCETRIS for up to ten additional cycles.
    • All 26 patients (100 percent) achieved an objective response following combination therapy, including 23 (88 percent) complete remissions and three (12 percent) partial remissions.
    • All patients in complete remission after combination therapy maintained response during maintenance. One patient with partial remission during combination treatment converted to complete remission during maintenance.
    • The median observation time from first dose of therapy was 21.4 months. The estimated one-year progression-free survival rate was 71 percent and one-year overall survival rate was 88 percent.
    • The most common treatment-emergent adverse events of any grade occurring in more than 40 percent of patients were peripheral sensory neuropathy (69 percent), nausea (65 percent), diarrhea (58 percent), fatigue (58 percent), shortness of breath (46 percent) and constipation (38 percent).
    • The most common Grade 3 treatment-emergent adverse events were febrile neutropenia, anemia and peripheral sensory neuropathy.

    Based on these results, a global phase 3 study called ECHELON-2 was initiated and is currently enrolling patients. The ECHELON-2 trial is a randomized, double-blind, placebo-controlled, multi-center trial designed to investigate A+CHP versus CHOP as frontline therapy in patients with CD30-expressing MTCL, also known as peripheral T-cell lymphoma. Approximately 300 patients (approximately 150 patients per treatment arm) will be randomized to receive A+CHP or CHOP for six to eight cycles every three weeks.

    Investigator-Sponsored Data Presentation

    Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #367)

    Data were presented from a phase 2 investigator-sponsored trial evaluating the use of ADCETRIS in CD30-positive CTCL patients, including lymphomatoid papulosis (LyP), primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF). The ongoing study is being conducted by Dr. Madeleine Duvic from The University of Texas MD Anderson Cancer Center in Houston, TX. The primary endpoints of the trial are to evaluate the safety and activity of ADCETRIS in CD30-positive CTCL. Among 56 patients enrolled to date, 48 patients had received at least two doses of ADCETRIS and were evaluable at the time of analysis. The key findings included:

    • Thirty-five of 48 patients (73 percent) achieved an objective response, including 20 of 20 (100 percent) with LyP and/or pcALCL and 15 of 28 (54 percent) with MF.
    • In patients with MF, the median time to response was 12 weeks and the median duration of response was 32 weeks. In patients with LyP and/or pcALCL, the median time to response was three weeks and the median duration of response was 26 weeks.
    • Responses were observed in patients with CD30 expression levels ranging from less than 10 percent to more than 50 percent based on standard screening methods.
    • The most common adverse events were peripheral neuropathy (65 percent), fatigue (41 percent) and rash (27 percent). Other common adverse events included nausea, neutropenia, myalgia, diarrhea and localized skin infection.
    • The most common Grade 3 adverse events were neutropenia (five three patients), nausea (two patients), chest pain (two patients), arthralgia (two patients) and infection (two patients). Other Grade 3 or 4 events occurring in one patient each included fatigue, deep vein thrombosis, elevated liver function tests and dehydration. Two patient deaths occurred due to untreated sepsis, including one elderly patient with ALCL after one dose and one patient due to a urinary tract infection.

    Seattle Genetics and Millennium: The Takeda Oncology Company are conducting the ALCANZA trial, a randomized phase 3 clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial is assessing ADCETRIS versus investigator’s choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with pcALCL or MF. The primary endpoint of the study is overall response rate lasting at least four months. Approximately 124 patients will be enrolled in the pivotal trial.

    Published in: Seattle Genetics Website, December 9, 2013

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