Relapse-free survival at three years was 56% for Yervoy 3 mg/kg and 54% for Yervoy 10 mg/kg
Treatment-related Grade 3/4 adverse events were experienced by 37% of patients in the Yervoy 3 mg/kg arm and 57% in the 10 mg/kg arm
PRINCETON, NJ, USA I June 4, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced results of an interim descriptive analysis from an ongoing National Cancer Institute (NCI) Phase 3 randomized study evaluating Yervoy (ipilimumab) 3 mg/kg and Yervoy 10 mg/kg in patients with stage III or resectable stage IV melanoma who are at high risk of recurrence following complete surgical resection. In this unplanned analysis of relapse-free survival (RFS) in concurrently randomized patients between the two experimental arms RFS at three years was 56% (n=367) for Yervoy 3 mg/kg (95% CI: 0.50, 0.61) and 54% (n=406) for Yervoy 10 mg/kg (95% CI: 0.49, 0.60).
All-Cause Grade 3/4 adverse events (AEs) were experienced by 53% of patients in the Yervoy 3mg/kg arm (n=516) and 66% of patients in the Yervoy 10 mg/kg (n=503) arm. Treatment-related Grade 3/4 AEs were experienced by 37% and 57% of patients in the Yervoy 3mg/kg and 10 mg/kg arms, respectively. Treatment-related AEs led to discontinuation in 35% of patients taking Yervoy 3 mg/kg and 54% taking Yervoy 10 mg/kg. There were eight deaths in the Yervoy 10 mg/kg arm and two in the Yervoy 3 mg/kg arm that were considered at least possibly treatment-related. These data will be presented during an oral session today from 8:00 – 8:12 a.m. CT during the Melanoma/Skin Cancers session in the Arie Crown Theater at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
“Adjuvant therapy with ipilimumab represents an important option for appropriate stage III melanoma patients following complete resection who have a significant risk of disease recurrence; however, management of adverse events is essential to help ensure that appropriate patients are able to benefit from treatment,” said Ahmad A. Tarhini, MD, PhD, University of Pittsburgh Cancer Institute. “These data are important because they advance our understanding of the benefits and risks of ipilimumab in the adjuvant setting.”
“There is a need for safe and effective treatment options for melanoma patients after surgery who are at high-risk of relapse, only about half of whom receive treatment,” said Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “This analysis provides valuable information that may help inform treatment decisions.”
E1609 is a Phase 3 study that enrolled 1,673 adult patients between May 2011 and August 2014 at multiple clinical sites, all belonging to the research groups in the NCI’s National Clinical Trials Network that design and lead trials focused on adult cancers: the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG. The study is comparing the effect of adjuvant Yervoy at either 3 mg/kg or 10 mg/kg versus high-dose interferon in adult patients with high-risk stage III or IV melanoma that has been removed by surgery. The study was not designed to compare the two Yervoy arms to each other. This analysis was performed to inform the effect of dose on efficacy and safety in the adjuvant setting. Co-primary endpoints of the study are overall survival and RFS comparing Yervoy versus high dose interferon α-2b. Secondary outcome measures include global quality of life and the safety profile of adjuvant Yervoy (10 mg/kg and 3 mg/kg) versus high-dose recombinant interferon α-2b. In this descriptive analysis, data was presented on the efficacy and safety of Yervoy 3 mg/kg and Yervoy 10 mg/kg at a median follow up of 3.1 years.
Adjuvant Therapy in Melanoma
Melanoma is separated into five staging categories (stages 0-4) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.
Stage 3 melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized), and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy, although adjuvant treatment options are very limited. Despite surgical intervention and possible adjuvant treatment, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage 3B and 3C patients (68% and 89%, respectively) and a third of stage 3A patients (37%) have experienced disease recurrence.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
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.
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.
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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Relapse-free survival at three years was 56% for Yervoy 3 mg/kg and 54% for Yervoy 10 mg/kg
Treatment-related Grade 3/4 adverse events were experienced by 37% of patients in the Yervoy 3 mg/kg arm and 57% in the 10 mg/kg arm
PRINCETON, NJ, USA I June 4, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced results of an interim descriptive analysis from an ongoing National Cancer Institute (NCI) Phase 3 randomized study evaluating Yervoy (ipilimumab) 3 mg/kg and Yervoy 10 mg/kg in patients with stage III or resectable stage IV melanoma who are at high risk of recurrence following complete surgical resection. In this unplanned analysis of relapse-free survival (RFS) in concurrently randomized patients between the two experimental arms RFS at three years was 56% (n=367) for Yervoy 3 mg/kg (95% CI: 0.50, 0.61) and 54% (n=406) for Yervoy 10 mg/kg (95% CI: 0.49, 0.60).
All-Cause Grade 3/4 adverse events (AEs) were experienced by 53% of patients in the Yervoy 3mg/kg arm (n=516) and 66% of patients in the Yervoy 10 mg/kg (n=503) arm. Treatment-related Grade 3/4 AEs were experienced by 37% and 57% of patients in the Yervoy 3mg/kg and 10 mg/kg arms, respectively. Treatment-related AEs led to discontinuation in 35% of patients taking Yervoy 3 mg/kg and 54% taking Yervoy 10 mg/kg. There were eight deaths in the Yervoy 10 mg/kg arm and two in the Yervoy 3 mg/kg arm that were considered at least possibly treatment-related. These data will be presented during an oral session today from 8:00 – 8:12 a.m. CT during the Melanoma/Skin Cancers session in the Arie Crown Theater at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
“Adjuvant therapy with ipilimumab represents an important option for appropriate stage III melanoma patients following complete resection who have a significant risk of disease recurrence; however, management of adverse events is essential to help ensure that appropriate patients are able to benefit from treatment,” said Ahmad A. Tarhini, MD, PhD, University of Pittsburgh Cancer Institute. “These data are important because they advance our understanding of the benefits and risks of ipilimumab in the adjuvant setting.”
“There is a need for safe and effective treatment options for melanoma patients after surgery who are at high-risk of relapse, only about half of whom receive treatment,” said Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “This analysis provides valuable information that may help inform treatment decisions.”
E1609 is a Phase 3 study that enrolled 1,673 adult patients between May 2011 and August 2014 at multiple clinical sites, all belonging to the research groups in the NCI’s National Clinical Trials Network that design and lead trials focused on adult cancers: the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG. The study is comparing the effect of adjuvant Yervoy at either 3 mg/kg or 10 mg/kg versus high-dose interferon in adult patients with high-risk stage III or IV melanoma that has been removed by surgery. The study was not designed to compare the two Yervoy arms to each other. This analysis was performed to inform the effect of dose on efficacy and safety in the adjuvant setting. Co-primary endpoints of the study are overall survival and RFS comparing Yervoy versus high dose interferon α-2b. Secondary outcome measures include global quality of life and the safety profile of adjuvant Yervoy (10 mg/kg and 3 mg/kg) versus high-dose recombinant interferon α-2b. In this descriptive analysis, data was presented on the efficacy and safety of Yervoy 3 mg/kg and Yervoy 10 mg/kg at a median follow up of 3.1 years.
Adjuvant Therapy in Melanoma
Melanoma is separated into five staging categories (stages 0-4) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.
Stage 3 melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized), and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy, although adjuvant treatment options are very limited. Despite surgical intervention and possible adjuvant treatment, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage 3B and 3C patients (68% and 89%, respectively) and a third of stage 3A patients (37%) have experienced disease recurrence.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
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.
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.
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: 45
