Overall response rate of 26.3% in patients with cervical cancer regardless of PD-L1, HPV status and number of prior systemic therapies
Median duration of response has not been reached after 6 months of follow-up
PRINCETON, NJ, USA I June 2, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced the first disclosure of data from a cohort of the Phase 1/2 CheckMate -358 study evaluating Opdivo (nivolumab) for the treatment of patients with advanced cervical, vaginal and vulvar cancers, all associated with infection by the human papillomavirus (HPV). The cohort included 24 patients, 19 of which were cervical cancer patients. The preliminary efficacy measures from the Phase 1/2 CheckMate -358 study (N=24) in patients with advanced cervical, vaginal and vulvar cancers, included an objective response rate (ORR), the primary endpoint, of 20.8% (95% CI: 7.1 to 42.2), with a 70.8% disease control rate of women experiencing complete or partial response or stable disease. The median progression-free survival (PFS) was 5.5 months (95% CI: 3.5 to not reached) and the median overall survival (OS) was not yet reached. Responses were seen only in cervical cancer patients. Of the 19 women with cervical cancer, five had complete and partial responses, with an ORR of 26.3% (95% CI: 9.1 to 51.2). Median duration of response has not been reached after 6 months of follow-up. Opdivo showed a safety profile consistent with previous results seen with Opdivo monotherapy in other tumor types. Grade 3/4 treatment-related adverse events (AEs) occurred in 12.5% of patients. These data will be presented today in an oral session at 4:12 to 4:24 PM CDT at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
“These CheckMate -358 results demonstrate the value of studying the potential of an Immuno-Oncology agent to address the significant challenge of treating patients with advanced cervical, vaginal and vulvar cancers,” said lead investigator Antoine Hollebecque, M.D., senior medical physician, Gustave Roussy Cancer Institute in Villejuif, France. “As a clinical investigator, I am encouraged by these findings in the women with advanced cervical cancer, and look forward to the anticipated data from the planned longer term analyses.”
HPV, which is transmitted through sexual contact, is linked with more than 90% of cervical cancers, about 75% of vaginal cancers and 69% of vulvar cancers. First-line treatment for women with advanced cervical cancer often consists of chemotherapy alone or combined with radiation, and the five-year survival rate for advanced cervical cancer, stages III and IV, ranges from about 35% to 16%.
“This first assessment of Opdivo’s activity in women with advanced cervical, vaginal and vulvar cancers enrolled in this cohort of CheckMate -358 supports further investigation, especially because these patients have very limited options after chemotherapy or radiation fails,” said Shinta Cheng, M.D., Ph.D., development lead, Bristol-Myers Squibb. “These trial results also underscore our continued commitment to explore how Immuno-Oncology therapy might benefit as many appropriate patients as possible, including those with virally associated cancers of the gynecological system.”
About CheckMate -358 (Abstract #5504)
CheckMate -358 is an ongoing Phase 1/2, open-label, international, multicenter, non-comparative, multi-cohort study that is evaluating the safety and efficacy of Opdivo monotherapy and Opdivo combination therapy in adult patients with virally associated tumors (Merkel cell carcinoma, gastric/gastroesophageal junction carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the head and neck, and squamous cell carcinoma of the cervix, vagina, vulva, anal canal and penis).
Patient tumor type, disease stage and resectability determined eligibility for enrollment in one of five treatment cohorts: neoadjuvant Opdivo monotherapy, metastatic Opdivo monotherapy, metastatic Opdivo combination therapy with Yervoy, metastatic Opdivo combination therapy with anti-LAG-3, or metastatic Opdivo combination therapy with daratumumab.
Patients in the neoadjuvant cohort received 2 doses of Opdivo 240 mg intravenously prior to scheduled surgery and patients in the monotherapy cohort were treated with Opdivo 240 mg intravenously every 2 weeks until unacceptable toxicity, withdrawal of consent or disease progression. The primary endpoints of the Phase 2 part of the study are objective response rate by investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and safety. Secondary endpoints include progression-free survival overall survival, and duration of response.
About HPV & Cervical, Vaginal and Vulvar Cancers
In the majority of patients with human papillomavirus (HPV), which is transmitted through sexual contact, the immune system is effective at eliminating the initial infection. However, 10% to 15% establish life-long persistent infection, which may lead to virally mediated immune suppression and increased risk of cancers like cervical, vaginal and vulvar.
Worldwide, cervical cancer is the fourth most frequent cancer in women with an estimated 530,000 new cases in 2012 and is responsible for 7.5% of all female cancer deaths. Globally, more than an estimated one million women currently live with cervical cancer, as a consequence of a long-term HPV infection. Cancers of the vagina and vulva are rarer than cervical cancer, with estimated new annual diagnoses of 13,000 and 27,000 respectively, which represented 2% and 4% of all gynecological cancers in 2008.
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 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 patients’ individual 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 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.
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: 49
Overall response rate of 26.3% in patients with cervical cancer regardless of PD-L1, HPV status and number of prior systemic therapies
Median duration of response has not been reached after 6 months of follow-up
PRINCETON, NJ, USA I June 2, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced the first disclosure of data from a cohort of the Phase 1/2 CheckMate -358 study evaluating Opdivo (nivolumab) for the treatment of patients with advanced cervical, vaginal and vulvar cancers, all associated with infection by the human papillomavirus (HPV). The cohort included 24 patients, 19 of which were cervical cancer patients. The preliminary efficacy measures from the Phase 1/2 CheckMate -358 study (N=24) in patients with advanced cervical, vaginal and vulvar cancers, included an objective response rate (ORR), the primary endpoint, of 20.8% (95% CI: 7.1 to 42.2), with a 70.8% disease control rate of women experiencing complete or partial response or stable disease. The median progression-free survival (PFS) was 5.5 months (95% CI: 3.5 to not reached) and the median overall survival (OS) was not yet reached. Responses were seen only in cervical cancer patients. Of the 19 women with cervical cancer, five had complete and partial responses, with an ORR of 26.3% (95% CI: 9.1 to 51.2). Median duration of response has not been reached after 6 months of follow-up. Opdivo showed a safety profile consistent with previous results seen with Opdivo monotherapy in other tumor types. Grade 3/4 treatment-related adverse events (AEs) occurred in 12.5% of patients. These data will be presented today in an oral session at 4:12 to 4:24 PM CDT at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017.
“These CheckMate -358 results demonstrate the value of studying the potential of an Immuno-Oncology agent to address the significant challenge of treating patients with advanced cervical, vaginal and vulvar cancers,” said lead investigator Antoine Hollebecque, M.D., senior medical physician, Gustave Roussy Cancer Institute in Villejuif, France. “As a clinical investigator, I am encouraged by these findings in the women with advanced cervical cancer, and look forward to the anticipated data from the planned longer term analyses.”
HPV, which is transmitted through sexual contact, is linked with more than 90% of cervical cancers, about 75% of vaginal cancers and 69% of vulvar cancers. First-line treatment for women with advanced cervical cancer often consists of chemotherapy alone or combined with radiation, and the five-year survival rate for advanced cervical cancer, stages III and IV, ranges from about 35% to 16%.
“This first assessment of Opdivo’s activity in women with advanced cervical, vaginal and vulvar cancers enrolled in this cohort of CheckMate -358 supports further investigation, especially because these patients have very limited options after chemotherapy or radiation fails,” said Shinta Cheng, M.D., Ph.D., development lead, Bristol-Myers Squibb. “These trial results also underscore our continued commitment to explore how Immuno-Oncology therapy might benefit as many appropriate patients as possible, including those with virally associated cancers of the gynecological system.”
About CheckMate -358 (Abstract #5504)
CheckMate -358 is an ongoing Phase 1/2, open-label, international, multicenter, non-comparative, multi-cohort study that is evaluating the safety and efficacy of Opdivo monotherapy and Opdivo combination therapy in adult patients with virally associated tumors (Merkel cell carcinoma, gastric/gastroesophageal junction carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the head and neck, and squamous cell carcinoma of the cervix, vagina, vulva, anal canal and penis).
Patient tumor type, disease stage and resectability determined eligibility for enrollment in one of five treatment cohorts: neoadjuvant Opdivo monotherapy, metastatic Opdivo monotherapy, metastatic Opdivo combination therapy with Yervoy, metastatic Opdivo combination therapy with anti-LAG-3, or metastatic Opdivo combination therapy with daratumumab.
Patients in the neoadjuvant cohort received 2 doses of Opdivo 240 mg intravenously prior to scheduled surgery and patients in the monotherapy cohort were treated with Opdivo 240 mg intravenously every 2 weeks until unacceptable toxicity, withdrawal of consent or disease progression. The primary endpoints of the Phase 2 part of the study are objective response rate by investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and safety. Secondary endpoints include progression-free survival overall survival, and duration of response.
About HPV & Cervical, Vaginal and Vulvar Cancers
In the majority of patients with human papillomavirus (HPV), which is transmitted through sexual contact, the immune system is effective at eliminating the initial infection. However, 10% to 15% establish life-long persistent infection, which may lead to virally mediated immune suppression and increased risk of cancers like cervical, vaginal and vulvar.
Worldwide, cervical cancer is the fourth most frequent cancer in women with an estimated 530,000 new cases in 2012 and is responsible for 7.5% of all female cancer deaths. Globally, more than an estimated one million women currently live with cervical cancer, as a consequence of a long-term HPV infection. Cancers of the vagina and vulva are rarer than cervical cancer, with estimated new annual diagnoses of 13,000 and 27,000 respectively, which represented 2% and 4% of all gynecological cancers in 2008.
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 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 patients’ individual 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 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.
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: 49
