55% of evaluable patients achieved an objective response
Median duration of response not reached, with a median follow-up of 7.1 months
SAN DIEGO, CA, USA I December 11, 2011 I New findings from a phase 1 trial presented yesterday at the 53rd Annual American Society of Hematology (ASH) Annual Meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.
Data presented at the meeting focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.
"The level of activity observed with a single agent in this heavily pre-treated patient population is unusual," said Andreas Viardot, M.D., Department of Medicine III, University of Ulm. "We look forward to further exploring blinatumomab’s activity in patients with relapsed diffuse large B cell lymphoma."
The most common clinical adverse events were grade 1 or 2 and included flu-like symptoms, pyrexia, headache, and fatigue. These were most frequently seen at the onset of treatment. The clinically most relevant adverse events were fully reversible central nervous system (CNS) events. A key objective of this study was to optimize the type and timing of steroid administration to mitigate the risk of developing CNS adverse events. Notably, no discontinuations due to CNS events were observed in the five patients who received an optimized steroid schedule including dexamethasone administration starting 12 hours before the start of blinatumomab infusion.
“With an improved steroid pre-medication schedule, we have successfully treated patients with relapsed diffuse large B cell lymphoma at the blinatumomab target dose,” said Jan Fagerberg, M.D., Ph.D., Micromet’s Senior Vice President and Chief Medical Officer. “We plan to initiate in 2012 a phase 2 trial in patients with diffuse large B cell lymphoma.”
Study design
This open-label, single-arm phase 1 study was designed to assess the safety and efficacy of blinatumomab in 76 patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) whose disease progressed despite prior treatment. Endpoints included safety, objective response rate, progression-free survival, time to disease progression, and overall survival.
Blinatumomab Experience in Indolent Lymphoma and Mantle Cell Lymphoma
Results from this study were reported at the 2011 Annual International Conference on Malignant Lymphoma. At the therapeutic dose level of 60 micrograms per meter squared per day, 71% of NHL patients (20 of 28) achieved an objective response, including 10 out of 12 follicular lymphoma patients and 4 out of 5 mantle cell lymphoma patients. The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant adverse events were fully reversible and manageable CNS events.
Phase 2 Trial in Patients with Relapsed Diffuse Large B-Cell Lymphoma
Based on the results reported at ASH, in 2012 the Company plans to initiate a phase 2 study intended to further evaluate the efficacy and safety of blinatumomab in patients with relapsed/refractory DLBCL. The primary endpoint of the study will be objective response rate according to Cheson criteria. Secondary endpoints will include duration of response, time to progression, overall survival, and incidence and severity of adverse events. Results from this trial will inform the Company’s registration strategy in this patient population.
Conference Call and Webcast
Micromet management will host a meeting for the investment community on Monday, December 12 beginning at 12 PM PT to review the data presented at ASH. To participate in the event, please dial 888-567-1602 (domestic) or 201-604-5049 (international) and reference the Micromet ASH analyst event. The presentation will be available via webcast in the Investors and Media section of the Micromet website at: www.micromet.com. The archived webcast will be available for 30 days at www.micromet.com.
About Blinatumomab
Blinatumomab (MT103) is a next-generation monoclonal antibody-based therapeutic designed to direct the body’s cell destroying T-cells against target cells expressing CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non-Hodgkin’s lymphomas. Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the U.S. Food and Drug Administration for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
About Micromet, Inc.
Micromet (NASDAQ: MITI – News) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. The Company is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. The Company’s lead product candidate blinatumomab (MT103) is currently the subject of a European pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Nycomed and Sanofi.
SOURCE: Micromet
Post Views: 59
55% of evaluable patients achieved an objective response
Median duration of response not reached, with a median follow-up of 7.1 months
SAN DIEGO, CA, USA I December 11, 2011 I New findings from a phase 1 trial presented yesterday at the 53rd Annual American Society of Hematology (ASH) Annual Meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.
Data presented at the meeting focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.
"The level of activity observed with a single agent in this heavily pre-treated patient population is unusual," said Andreas Viardot, M.D., Department of Medicine III, University of Ulm. "We look forward to further exploring blinatumomab’s activity in patients with relapsed diffuse large B cell lymphoma."
The most common clinical adverse events were grade 1 or 2 and included flu-like symptoms, pyrexia, headache, and fatigue. These were most frequently seen at the onset of treatment. The clinically most relevant adverse events were fully reversible central nervous system (CNS) events. A key objective of this study was to optimize the type and timing of steroid administration to mitigate the risk of developing CNS adverse events. Notably, no discontinuations due to CNS events were observed in the five patients who received an optimized steroid schedule including dexamethasone administration starting 12 hours before the start of blinatumomab infusion.
“With an improved steroid pre-medication schedule, we have successfully treated patients with relapsed diffuse large B cell lymphoma at the blinatumomab target dose,” said Jan Fagerberg, M.D., Ph.D., Micromet’s Senior Vice President and Chief Medical Officer. “We plan to initiate in 2012 a phase 2 trial in patients with diffuse large B cell lymphoma.”
Study design
This open-label, single-arm phase 1 study was designed to assess the safety and efficacy of blinatumomab in 76 patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) whose disease progressed despite prior treatment. Endpoints included safety, objective response rate, progression-free survival, time to disease progression, and overall survival.
Blinatumomab Experience in Indolent Lymphoma and Mantle Cell Lymphoma
Results from this study were reported at the 2011 Annual International Conference on Malignant Lymphoma. At the therapeutic dose level of 60 micrograms per meter squared per day, 71% of NHL patients (20 of 28) achieved an objective response, including 10 out of 12 follicular lymphoma patients and 4 out of 5 mantle cell lymphoma patients. The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant adverse events were fully reversible and manageable CNS events.
Phase 2 Trial in Patients with Relapsed Diffuse Large B-Cell Lymphoma
Based on the results reported at ASH, in 2012 the Company plans to initiate a phase 2 study intended to further evaluate the efficacy and safety of blinatumomab in patients with relapsed/refractory DLBCL. The primary endpoint of the study will be objective response rate according to Cheson criteria. Secondary endpoints will include duration of response, time to progression, overall survival, and incidence and severity of adverse events. Results from this trial will inform the Company’s registration strategy in this patient population.
Conference Call and Webcast
Micromet management will host a meeting for the investment community on Monday, December 12 beginning at 12 PM PT to review the data presented at ASH. To participate in the event, please dial 888-567-1602 (domestic) or 201-604-5049 (international) and reference the Micromet ASH analyst event. The presentation will be available via webcast in the Investors and Media section of the Micromet website at: www.micromet.com. The archived webcast will be available for 30 days at www.micromet.com.
About Blinatumomab
Blinatumomab (MT103) is a next-generation monoclonal antibody-based therapeutic designed to direct the body’s cell destroying T-cells against target cells expressing CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non-Hodgkin’s lymphomas. Micromet has received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the U.S. Food and Drug Administration for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia and indolent B cell lymphoma.
About Micromet, Inc.
Micromet (NASDAQ: MITI – News) is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. The Company is advancing a robust pipeline of novel therapeutics based on its proprietary BiTE® technology. The Company’s lead product candidate blinatumomab (MT103) is currently the subject of a European pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Amgen, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, MedImmune, Nycomed and Sanofi.
SOURCE: Micromet
Post Views: 59
