BLA submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma
PRINCETON, NJ, USA I December 18, 2019 IBristol-Myers Squibb Company (NYSE: BMY) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.
The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently presented data from this pivotal study at the American Society of Hematology annual meeting.
Liso-cel has been granted Breakthrough Therapy (BT) and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA for relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma (NHL), including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority Medicines (PRIME) scheme by the European Medicines Agency for relapsed/refractory DLBCL.
Liso-cel is an investigational compound that is not approved for use in any country.
About Diffuse Large B-cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL, accounting for three out of every five cases. Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease. Historically, median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.
Bristol-Myers Squibb: Advancing Cancer Research
At Bristol-Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.
About Lisocabtagene Maraleucel (liso-cel)
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain. The defined composition of CAR-positive viable T-cells (consisting of CD8 and CD4 components) in liso-cel may reduce product variability; however, the clinical significance of defined composition is unknown.
About TRANSCEND NHL 001
TRANSCEND NHL 001 is an open-label, multicenter, pivotal phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of liso-cel in patients with relapsed/refractory B-cell NHL, including DLBCL, PMBCL, Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Secondary outcome measures included complete response rate, duration of response, and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple disease states and treatment stages.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol-Myers Squibb
Post Views: 249
BLA submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma
PRINCETON, NJ, USA I December 18, 2019 IBristol-Myers Squibb Company (NYSE: BMY) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.
The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently presented data from this pivotal study at the American Society of Hematology annual meeting.
Liso-cel has been granted Breakthrough Therapy (BT) and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA for relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma (NHL), including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority Medicines (PRIME) scheme by the European Medicines Agency for relapsed/refractory DLBCL.
Liso-cel is an investigational compound that is not approved for use in any country.
About Diffuse Large B-cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL, accounting for three out of every five cases. Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease. Historically, median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.
Bristol-Myers Squibb: Advancing Cancer Research
At Bristol-Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.
About Lisocabtagene Maraleucel (liso-cel)
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain. The defined composition of CAR-positive viable T-cells (consisting of CD8 and CD4 components) in liso-cel may reduce product variability; however, the clinical significance of defined composition is unknown.
About TRANSCEND NHL 001
TRANSCEND NHL 001 is an open-label, multicenter, pivotal phase 1 study to determine the safety, pharmacokinetics, and antitumor activity of liso-cel in patients with relapsed/refractory B-cell NHL, including DLBCL, PMBCL, Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Secondary outcome measures included complete response rate, duration of response, and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple disease states and treatment stages.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol-Myers Squibb
Post Views: 249
