NEW YORK, NY, USA I April 21, 2015 I Pfizer today announced that the Phase 3 study investigating the treatment of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard of care chemotherapy.
The Phase 3 study has two primary endpoints, complete hematologic remission rate and overall survival. Pfizer is continuing the study to allow for the data on overall survival to mature.
“We are excited about the results of the INO-VATE ALL study especially since relapsed and refractory acute lymphoblastic leukemia is a particularly difficult disease to treat in adults. The top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option for patients with relapsed or refractory disease,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “We look forward to discussing these data with the FDA and other regulatory authorities.”
No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting.
About the INO-VATE ALL Study
The INO-VATE ALL Study, also known as Study 1022, is an open-label, randomized, Phase 3 study evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin as compared with a defined set of chemotherapy choices in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL).
The two primary endpoints are hematologic remission, defined as a complete response with or without platelet and/or neutrophil recovery (CR/CRi), and overall survival. Secondary endpoints include progression-free survival, volume of distribution and systemic clearance for inotuzumab ozogamicin in serum, duration of response, rate of stem-cell transplantation, minimal residual disease, cytogenetics, safety and quality of life (European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire, Core-30 and EuroQual-5D Health Questionnaire).1
Inotuzumab ozogamicin was administered intravenously once weekly for three weeks for a three to four week cycle up to six cycles. Chemotherapy options included fludarabine, cytarabine and G-CSF (FLAG); high dose cytarabine (HIDAC); or cytarabine and mitoxantrone.2
There were 326 patients enrolled in the trial. Enrollment is now complete.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.3 The current foundational treatment is intensive, long-term chemotherapy.4 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.5 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.6
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22,7 a cell surface antigen expressed on approximately 90 percent of B-cell malignancies,8 linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.9
Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information, please visit www.Pfizer.com.
SOURCE: Pfizer
Post Views: 154
NEW YORK, NY, USA I April 21, 2015 I Pfizer today announced that the Phase 3 study investigating the treatment of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard of care chemotherapy.
The Phase 3 study has two primary endpoints, complete hematologic remission rate and overall survival. Pfizer is continuing the study to allow for the data on overall survival to mature.
“We are excited about the results of the INO-VATE ALL study especially since relapsed and refractory acute lymphoblastic leukemia is a particularly difficult disease to treat in adults. The top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option for patients with relapsed or refractory disease,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “We look forward to discussing these data with the FDA and other regulatory authorities.”
No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting.
About the INO-VATE ALL Study
The INO-VATE ALL Study, also known as Study 1022, is an open-label, randomized, Phase 3 study evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin as compared with a defined set of chemotherapy choices in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL).
The two primary endpoints are hematologic remission, defined as a complete response with or without platelet and/or neutrophil recovery (CR/CRi), and overall survival. Secondary endpoints include progression-free survival, volume of distribution and systemic clearance for inotuzumab ozogamicin in serum, duration of response, rate of stem-cell transplantation, minimal residual disease, cytogenetics, safety and quality of life (European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire, Core-30 and EuroQual-5D Health Questionnaire).1
Inotuzumab ozogamicin was administered intravenously once weekly for three weeks for a three to four week cycle up to six cycles. Chemotherapy options included fludarabine, cytarabine and G-CSF (FLAG); high dose cytarabine (HIDAC); or cytarabine and mitoxantrone.2
There were 326 patients enrolled in the trial. Enrollment is now complete.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.3 The current foundational treatment is intensive, long-term chemotherapy.4 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.5 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.6
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22,7 a cell surface antigen expressed on approximately 90 percent of B-cell malignancies,8 linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.9
Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information, please visit www.Pfizer.com.
SOURCE: Pfizer
Post Views: 154
