Updated results from CheckMate -214 study show that more than 50% of patients treated with Opdivo plus Yervoy were alive at 42 months compared to 39% of patients treated with sunitinib
Complete response rates, per independent review, for patients treated with Opdivo plus Yervoy were maintained and ongoing in over 80% of patients
Results represent the longest follow-up with any immuno-oncology–based therapy in this setting
PRINCETON, NJ, USA I February 15, 2020 IBristol-Myers Squibb Company (NYSE: BMY) today announced updated results from the Phase 3 CheckMate -214 study evaluating the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). With a minimum follow-up of 42 months, the combination of Opdivo plus Yervoy continues to show superior overall survival (OS), objective response rates (ORR), duration of response (DOR) and complete response (CR) rates. The safety profile for Opdivo plus Yervoy was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up. The data will be featured in an oral presentation (Abstract #609) on Saturday, February 15, 2020 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.
A significant OS benefit was observed in both patients from the intermediate- and poor-risk (IP) and the intent-to-treat (ITT, i.e. all randomized) populations treated with Opdivo plus Yervoy compared to those treated with sunitinib alone. Of the patients treated with Opdivo plus Yervoy who experienced a complete response, per independent review, that response was ongoing in 84% and 86% of patients in the IP and ITT populations, respectively.
In the IP populations, patients treated with Opdivo plus Yervoy demonstrated significantly improved:
- OS: At 42 months, the OS rate was 52% for patients treated with Opdivo plus Yervoy and 39% for patients treated with sunitinib alone [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.55-0.80)].
- ORR: Per independent review, ORR was 42% with Opdivo plus Yervoy and 26% for sunitinib (p=0.0001).
- DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 19.7 months (95% CI: 16.4-26.4) for patients treated with sunitinib.
- CR: Per independent review, 10% of patients treated with Opdivo plus Yervoy experienced a CR compared to 1% with sunitinib alone.
Results were similar for the ITT population, where patients treated with Opdivo plus Yervoy experienced significantly improved:
- OS: At 42 months, the OS rate for the ITT population was 56% for patients treated with Opdivo plus Yervoy and 47% for patients treated with sunitinib alone [HR 0.72 (95% CI: 0.61-0.86)].
- ORR: Per independent review, ORR was 39% with Opdivo plus Yervoy and 33% for sunitinib (p=0.02).
- DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 24.8 months (95% CI: 19.4-27.3) for patients treated with sunitinib.
- CR: Per independent review, 11% of patients treated with Opdivo plus Yervoy experienced a CR compared to 2% with sunitinib alone.
“Results from this 42-month follow-up from the CheckMate -214 study reinforce the previously observed findings and add to the growing body of evidence suggesting that nivolumab plus ipilimumab has the potential to significantly improve long-term survival for patients with advanced renal cell carcinoma, a population with high unmet needs,” said CheckMate -214 investigator Nizar M. Tannir, MD, FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “Particularly noteworthy is that a consistently higher proportion of patients treated with the combination of nivolumab plus ipilimumab achieved a complete response and the majority of these complete responses were durable.”
“These positive findings from CheckMate -214 continue to demonstrate the complementary nature of dual immuno-therapy and reinforce the depth and durability of response the combination of Opdivo plus Yervoy can deliver for patients,” said Brian Lamon, Ph.D., development lead, genitourinary cancers, Bristol-Myers Squibb. “We look forward to continuing to explore the potential that this combination holds for patients with difficult-to-treat cancers.”
About CheckMate -214
CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses followed by Opdivo 3 mg/kg every two weeks. Patients in the comparator group received sunitinib 50 mg once daily for four weeks, followed by two weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects. The primary endpoints of the trial are overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in an intermediate to poor-risk patient population (approximately 75% of patients).
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
Bristol-Myers Squibb: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.
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 treated more than 35,000 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 65 countries, including the United States, the European Union, Japan and China. 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 unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
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 metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. 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 advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
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), as a single agent, is indicated for the treatment of adult 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), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older 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.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
Indications and Important Safety Information for YERVOY®(ipilimumab)
Indications
YERVOY® (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older).
YERVOY® (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Checkmate Trials and Patient Populations
Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., 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, Ono and Bristol-Myers Squibb 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, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.
SOURCE: Bristol-Myers Squibb
Post Views: 129
Updated results from CheckMate -214 study show that more than 50% of patients treated with Opdivo plus Yervoy were alive at 42 months compared to 39% of patients treated with sunitinib
Complete response rates, per independent review, for patients treated with Opdivo plus Yervoy were maintained and ongoing in over 80% of patients
Results represent the longest follow-up with any immuno-oncology–based therapy in this setting
PRINCETON, NJ, USA I February 15, 2020 IBristol-Myers Squibb Company (NYSE: BMY) today announced updated results from the Phase 3 CheckMate -214 study evaluating the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). With a minimum follow-up of 42 months, the combination of Opdivo plus Yervoy continues to show superior overall survival (OS), objective response rates (ORR), duration of response (DOR) and complete response (CR) rates. The safety profile for Opdivo plus Yervoy was consistent with prior findings and no new safety signals or drug-related deaths occurred with extended follow-up. The data will be featured in an oral presentation (Abstract #609) on Saturday, February 15, 2020 at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.
A significant OS benefit was observed in both patients from the intermediate- and poor-risk (IP) and the intent-to-treat (ITT, i.e. all randomized) populations treated with Opdivo plus Yervoy compared to those treated with sunitinib alone. Of the patients treated with Opdivo plus Yervoy who experienced a complete response, per independent review, that response was ongoing in 84% and 86% of patients in the IP and ITT populations, respectively.
In the IP populations, patients treated with Opdivo plus Yervoy demonstrated significantly improved:
- OS: At 42 months, the OS rate was 52% for patients treated with Opdivo plus Yervoy and 39% for patients treated with sunitinib alone [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.55-0.80)].
- ORR: Per independent review, ORR was 42% with Opdivo plus Yervoy and 26% for sunitinib (p=0.0001).
- DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 19.7 months (95% CI: 16.4-26.4) for patients treated with sunitinib.
- CR: Per independent review, 10% of patients treated with Opdivo plus Yervoy experienced a CR compared to 1% with sunitinib alone.
Results were similar for the ITT population, where patients treated with Opdivo plus Yervoy experienced significantly improved:
- OS: At 42 months, the OS rate for the ITT population was 56% for patients treated with Opdivo plus Yervoy and 47% for patients treated with sunitinib alone [HR 0.72 (95% CI: 0.61-0.86)].
- ORR: Per independent review, ORR was 39% with Opdivo plus Yervoy and 33% for sunitinib (p=0.02).
- DOR: Median DOR was not reached for patients treated with Opdivo plus Yervoy and was 24.8 months (95% CI: 19.4-27.3) for patients treated with sunitinib.
- CR: Per independent review, 11% of patients treated with Opdivo plus Yervoy experienced a CR compared to 2% with sunitinib alone.
“Results from this 42-month follow-up from the CheckMate -214 study reinforce the previously observed findings and add to the growing body of evidence suggesting that nivolumab plus ipilimumab has the potential to significantly improve long-term survival for patients with advanced renal cell carcinoma, a population with high unmet needs,” said CheckMate -214 investigator Nizar M. Tannir, MD, FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “Particularly noteworthy is that a consistently higher proportion of patients treated with the combination of nivolumab plus ipilimumab achieved a complete response and the majority of these complete responses were durable.”
“These positive findings from CheckMate -214 continue to demonstrate the complementary nature of dual immuno-therapy and reinforce the depth and durability of response the combination of Opdivo plus Yervoy can deliver for patients,” said Brian Lamon, Ph.D., development lead, genitourinary cancers, Bristol-Myers Squibb. “We look forward to continuing to explore the potential that this combination holds for patients with difficult-to-treat cancers.”
About CheckMate -214
CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses followed by Opdivo 3 mg/kg every two weeks. Patients in the comparator group received sunitinib 50 mg once daily for four weeks, followed by two weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects. The primary endpoints of the trial are overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in an intermediate to poor-risk patient population (approximately 75% of patients).
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
Bristol-Myers Squibb: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.
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 treated more than 35,000 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 65 countries, including the United States, the European Union, Japan and China. 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 unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
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 metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. 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 advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
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), as a single agent, is indicated for the treatment of adult 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), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older 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.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
Indications and Important Safety Information for YERVOY®(ipilimumab)
Indications
YERVOY® (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older).
YERVOY® (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Checkmate Trials and Patient Populations
Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., 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, Ono and Bristol-Myers Squibb 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, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.
SOURCE: Bristol-Myers Squibb
Post Views: 129
