NEW YORK, NY, USA & STRASBOURG, France I April 25, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) and Transgene today announced a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.
The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine designed to generate an immune response against MUC1 expressing tumors such as NSCLC, in conjunction with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo, designed to alleviate immune suppression. Both therapies will be combined with standard chemotherapy in first line NSCLC patients. The Phase 2 trial will evaluate objective tumor responses, and disease control in patients provided the regimen of TG4010 + Opdivo + CT, whose tumors express low and undetectable levels of PD-L1. In addition, the study will evaluate safety and tolerability of this regimen together with other efficacy metrics. This multi-center single-arm trial is expected to deliver first results in 2018.
Under the terms of the agreement, Transgene will be the sponsor of the trial. Bristol-Myers Squibb will provide Opdivo for use in the study.
“We are excited to explore the potential benefits of combining Opdivo with an investigational therapeutic vaccine, TG4010, in NSCLC where the need for new therapies is particularly acute,” said Fouad Namouni, M.D., head of Oncology Development, Bristol-Myers Squibb. “As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with potential combinations of therapies that may help advance new therapeutic approaches for patients in need of better options.”
“We are enthusiastic about this new collaboration with Bristol-Myers Squibb. This trial will assess the potential of Transgene’s TG4010, an investigational therapeutic vaccine that is designed to stimulate the immune system, in combination with nivolumab, Bristol-Myers Squibb’s immune checkpoint inhibitor, and standard chemotherapy. Based on the results obtained with TG4010 in a large Phase 2b trial (TIME trial) in combination with chemotherapy, we are hopeful that this triple combination regimen could provide a treatment option for patients with advanced NSCLC,” commented Philippe Archinard, Chairman and CEO Transgene.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). TG4010, which is based on a modified vaccinia virus (MVA), induces an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC).
The results from the Phase 2b TIME trial with TG4010 immunotherapy associated with chemotherapy in NSCLC have been published in the peer-reviewed medical journal, The Lancet Oncology in December 2015.
About Non-Small Cell Lung Cancer
Lung cancer is one of the most common malignancies worldwide with an estimated 1.8 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated nearly 1.6 million deaths in 2012 (Source: GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease.
U. S. FDA APPROVED INDICATIONS FOR OPDIVO ®
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Checkmate Trials and Patient Populations
Checkmate 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 017 – squamous non-small cell lung cancer (NSCLC); Checkmate 057 – non-squamous NSCLC; Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma; Checkmate 141 – squamous cell carcinoma of the head and neck; Checkmate 275 – urothelial carcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
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 and Facebook.
About Transgene
Transgene S.A. (Euronext:TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing immune-targeted viral-based therapies for the treatment of cancers and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010, a therapeutic vaccine for non-small cell lung cancer, and Pexa-Vec, an oncolytic virus for liver cancer. The Company has several other programs, including TG4001, in clinical and preclinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China. Additional information about Transgene is available at www.transgene.fr.
SOURCE: Bristol-Myers Squibb
Post Views: 81
NEW YORK, NY, USA & STRASBOURG, France I April 25, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) and Transgene today announced a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.
The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine designed to generate an immune response against MUC1 expressing tumors such as NSCLC, in conjunction with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo, designed to alleviate immune suppression. Both therapies will be combined with standard chemotherapy in first line NSCLC patients. The Phase 2 trial will evaluate objective tumor responses, and disease control in patients provided the regimen of TG4010 + Opdivo + CT, whose tumors express low and undetectable levels of PD-L1. In addition, the study will evaluate safety and tolerability of this regimen together with other efficacy metrics. This multi-center single-arm trial is expected to deliver first results in 2018.
Under the terms of the agreement, Transgene will be the sponsor of the trial. Bristol-Myers Squibb will provide Opdivo for use in the study.
“We are excited to explore the potential benefits of combining Opdivo with an investigational therapeutic vaccine, TG4010, in NSCLC where the need for new therapies is particularly acute,” said Fouad Namouni, M.D., head of Oncology Development, Bristol-Myers Squibb. “As the science around cancer research continues to rapidly evolve, we are building on our leadership in Immuno-Oncology with potential combinations of therapies that may help advance new therapeutic approaches for patients in need of better options.”
“We are enthusiastic about this new collaboration with Bristol-Myers Squibb. This trial will assess the potential of Transgene’s TG4010, an investigational therapeutic vaccine that is designed to stimulate the immune system, in combination with nivolumab, Bristol-Myers Squibb’s immune checkpoint inhibitor, and standard chemotherapy. Based on the results obtained with TG4010 in a large Phase 2b trial (TIME trial) in combination with chemotherapy, we are hopeful that this triple combination regimen could provide a treatment option for patients with advanced NSCLC,” commented Philippe Archinard, Chairman and CEO Transgene.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
About TG4010
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). TG4010, which is based on a modified vaccinia virus (MVA), induces an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC).
The results from the Phase 2b TIME trial with TG4010 immunotherapy associated with chemotherapy in NSCLC have been published in the peer-reviewed medical journal, The Lancet Oncology in December 2015.
About Non-Small Cell Lung Cancer
Lung cancer is one of the most common malignancies worldwide with an estimated 1.8 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated nearly 1.6 million deaths in 2012 (Source: GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease.
U. S. FDA APPROVED INDICATIONS FOR OPDIVO ®
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Checkmate Trials and Patient Populations
Checkmate 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 017 – squamous non-small cell lung cancer (NSCLC); Checkmate 057 – non-squamous NSCLC; Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma; Checkmate 141 – squamous cell carcinoma of the head and neck; Checkmate 275 – urothelial carcinoma.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
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 and Facebook.
About Transgene
Transgene S.A. (Euronext:TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing immune-targeted viral-based therapies for the treatment of cancers and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010, a therapeutic vaccine for non-small cell lung cancer, and Pexa-Vec, an oncolytic virus for liver cancer. The Company has several other programs, including TG4001, in clinical and preclinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China. Additional information about Transgene is available at www.transgene.fr.
SOURCE: Bristol-Myers Squibb
Post Views: 81
