Phase 1b Study to Combine TAR-200 (GemRIS™) with Opdivo ® (nivolumab) in the Treatment of Muscle Invasive Bladder Cancer
LEXINGTON, MA & NEW YORK, NY, USA I December 20, 2017 I TARIS Biomedical LLC, and Bristol-Myers Squibb (NYSE:BMY) today announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b trial will evaluate the combination in patients with Muscle Invasive Bladder Cancer (MIBC) who are scheduled for radical cystectomy. In conjunction with this collaboration, Bristol-Myers Squibb also made an equity investment in TARIS.
Bladder cancer affects more than 2.7 million patients worldwide, and is among one of the most expensive types of cancers to treat on a per-patient lifetime basis. Few options are available to treat MIBC, which often may metastasize and leads to death.
“This is the first study evaluating the potential benefits of combining TAR-200 with a systemically administered immune checkpoint inhibitor,” said Purnanand Sarma, Ph.D., president and CEO of TARIS. “MIBC is a potentially lethal disease with high unmet clinical need. We are excited to partner with Bristol-Myers Squibb, a world-leader in oncology, to advance approaches that may provide meaningful benefit to patients.”
“We continue to explore multiple approaches to treating cancer as part of our broad research program focused on delivering the next wave of oncology therapies,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “Partnering with TARIS will allow us to advance our scientific understanding of combining Opdivo with continuous local chemotherapy as we seek to improve outcomes for patients with this aggressive form of bladder cancer.”
About TARIS System and TAR-200 (GemRIS™)
The TARIS® System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over seven days.
About TARIS Biomedical ®
TARIS Biomedical® is building a unique therapeutically-focused urology company, developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases. We are advancing therapies for debilitating conditions, including bladder cancer and overactive bladder, enabled by continuous local dosing where it is needed. www.tarisbiomedical.com
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.
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 adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. 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.
OPDIVO® (nivolumab) is indicated for the treatment of adults and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. 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 hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the 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; Checkmate 040 – hepatocellular carcinoma.
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.
SOURCE: Bristol-Myers Squibb
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Phase 1b Study to Combine TAR-200 (GemRIS™) with Opdivo ® (nivolumab) in the Treatment of Muscle Invasive Bladder Cancer
LEXINGTON, MA & NEW YORK, NY, USA I December 20, 2017 I TARIS Biomedical LLC, and Bristol-Myers Squibb (NYSE:BMY) today announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b trial will evaluate the combination in patients with Muscle Invasive Bladder Cancer (MIBC) who are scheduled for radical cystectomy. In conjunction with this collaboration, Bristol-Myers Squibb also made an equity investment in TARIS.
Bladder cancer affects more than 2.7 million patients worldwide, and is among one of the most expensive types of cancers to treat on a per-patient lifetime basis. Few options are available to treat MIBC, which often may metastasize and leads to death.
“This is the first study evaluating the potential benefits of combining TAR-200 with a systemically administered immune checkpoint inhibitor,” said Purnanand Sarma, Ph.D., president and CEO of TARIS. “MIBC is a potentially lethal disease with high unmet clinical need. We are excited to partner with Bristol-Myers Squibb, a world-leader in oncology, to advance approaches that may provide meaningful benefit to patients.”
“We continue to explore multiple approaches to treating cancer as part of our broad research program focused on delivering the next wave of oncology therapies,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “Partnering with TARIS will allow us to advance our scientific understanding of combining Opdivo with continuous local chemotherapy as we seek to improve outcomes for patients with this aggressive form of bladder cancer.”
About TARIS System and TAR-200 (GemRIS™)
The TARIS® System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over seven days.
About TARIS Biomedical ®
TARIS Biomedical® is building a unique therapeutically-focused urology company, developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases. We are advancing therapies for debilitating conditions, including bladder cancer and overactive bladder, enabled by continuous local dosing where it is needed. www.tarisbiomedical.com
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.
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 adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. 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.
OPDIVO® (nivolumab) is indicated for the treatment of adults and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. 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 hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the 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; Checkmate 040 – hepatocellular carcinoma.
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.
SOURCE: Bristol-Myers Squibb
Post Views: 17
