PARIS, France & PRINCETON, NJ, USA I June 5, 2017 I The French Cooperative Thoracic Intergroup (IFCT) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY) announced today results from the IFCT-1501 MAPS-2 trial evaluating the safety and efficacy of nivolumab or nivolumab combined with ipilimumab for previously treated unresectable malignant pleural mesothelioma (MPM) patients. The study was sponsored by the IFCT. Bristol-Myers Squibb supplied nivolumab and ipilimumab, and a research grant to the IFCT.
The 12-week disease control rate, the primary endpoint of the study, was 44.4% [95% CI: 31.2-57.7%] with nivolumab, and 50% [36.7-63.3%] with nivolumab plus ipilimumab, as assessed by an independent panel of radiologists. The objective response rate was 18.5% [8.2%-28.9%] with nivolumab, and 25.9% [14.2-37.6%] with nivolumab plus ipilimumab. The median overall survival was 10.4 months with nivolumab and not reached for the combined-treatment group. The progression-free survival was 4.0 months for monotherapy and 5.6 months for the combined-treatment group. The numbers of all Grade and Grade 3-4 toxicities were 86.9% and 18% in the combined-treatment group versus 77.8% and 9.5% with nivolumab alone.
These data will be featured today, June 5, during the Annual Meeting of the American Society of Clinical Oncology (ASCO) press briefing at 8:00 AM CDT and presented during an oral session from 10:12-10:24 AM CDT (Abstract LBA8507).
Arnaud Scherpereel, M.D., principal investigator of the study, head of the Pulmonary and Thoracic Oncology Department at the University Hospital (CHU) of Lille in France, stated: “For too long, patients with mesothelioma have been underserved in terms of treatment options compared with other types of cancers. The encouraging results of the previous IFCT trial, reported at the ASCO 2015 annual meeting, showed that when bevacizumab was used with the current standard-of-care combination of pemetrexed and cisplatin, it improved survival in patients with mesothelioma. Unfortunately, all patients in that study experienced disease progression. The results of IFCT-1501 MAPS-2 study, showing the efficacy and safety of nivolumab alone or in combination with ipilimumab, are promising, and additional research is needed for patients with relapsed mesothelioma.”
Nick Botwood, M.D., development lead, Thoracic Malignancies, Bristol-Myers Squibb, stated: “We would like to thank the researchers at IFCT, and the patients who participated in this important clinical trial. There has been little progress over the past decade in the treatment of malignant pleural mesothelioma, and for patients whose disease progresses following initial chemotherapy, there are limited data to guide subsequent treatment. The encouraging disease control rates seen in this study for nivolumab plus ipilimumab and nivolumab alone support further study of I-O therapy in mesothelioma. BMS is committed to continued research in thoracic cancers and is exploring the potential of I-O regimens for mesothelioma, with the hope of improving outcomes for patients with this rare, devastating disease.”
About IFCT-1501 MAPS-2
MAPS-2 is a Phase 2 multi-center randomized, non-comparative study evaluating nivolumab monotherapy and nivolumab plus ipilimumab combination therapy in patients with previously treated recurrent malignant pleural mesothelioma (MPM).
From March to August 2016, 125 patients were enrolled in 21 centers in France. Eligible patients, previously treated by 1 or 2 systemic chemotherapy lines, were randomized into two treatment groups: Patients received nivolumab (3 mg/kg every 2 weeks) or nivolumab (3 mg/kg every 2 weeks) combined with ipilimumab (1 mg/kg every 6 weeks) until progression or unacceptable toxicity.
The primary endpoint is disease control rate (DCR). Secondary endpoints include number of participants with treatment-related adverse events, progression-free survival, overall survival, quality of life, evaluation of predictive value of tumor PD-L1 score and prognostic value of biomarkers.
Rationale for immunotherapy in mesothelioma
MPM is a highly aggressive tumour. Asbestos exposure is the main factor involved in pathogenesis, which can explain the rise in incidence of mesothelioma patients since the 1960s (Bertazzi 2005, Goldberg 2006). Although mesothelioma is rare in the general population (prevalence in the non-exposed population <1 case/million individuals per year), around 100 cases per million per year in exposed individuals leads to an incidence between 900 and 1000 cases per year in France (Le Stang 2010, Cherié-Chaline 2012). Mesothelioma is a disease in which immune and inflammatory host response is thought to play a major role. Early data indicate that the combination of PD-1 and CTLA-4 receptor blockade may improve antitumor activity, and suggest further study to evaluate anti-PD-1 plus anti-CTLA-4 combination in MPM patients.
About the French Cooperative Thoracic intergroup (IFCT)
The IFCT is an independent, non-profit academic research intergroup specializing in thoracic oncology. Its objective is to improve survival and quality of life for thoracic cancer patients. Established in 1999, the IFCT has its own operational infrastructure and is equipped to design, promote, and carry out clinical studies in France and internationally, and to communicate the findings thus obtained. The IFCT’s activity regularly results in the introduction of new drugs or strategies that improve the efficacy, safety, and/or economic impact of anti-cancer therapies. This, in turn, leads to better patient management. All IFCT projects are coordinated by a Clinical Research Unit accredited by the National Cancer Institute (INCa) and the National League Against Cancer.
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 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 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 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.
SOURCE: Bristol-Myers Squibb
Post Views: 76
PARIS, France & PRINCETON, NJ, USA I June 5, 2017 I The French Cooperative Thoracic Intergroup (IFCT) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY) announced today results from the IFCT-1501 MAPS-2 trial evaluating the safety and efficacy of nivolumab or nivolumab combined with ipilimumab for previously treated unresectable malignant pleural mesothelioma (MPM) patients. The study was sponsored by the IFCT. Bristol-Myers Squibb supplied nivolumab and ipilimumab, and a research grant to the IFCT.
The 12-week disease control rate, the primary endpoint of the study, was 44.4% [95% CI: 31.2-57.7%] with nivolumab, and 50% [36.7-63.3%] with nivolumab plus ipilimumab, as assessed by an independent panel of radiologists. The objective response rate was 18.5% [8.2%-28.9%] with nivolumab, and 25.9% [14.2-37.6%] with nivolumab plus ipilimumab. The median overall survival was 10.4 months with nivolumab and not reached for the combined-treatment group. The progression-free survival was 4.0 months for monotherapy and 5.6 months for the combined-treatment group. The numbers of all Grade and Grade 3-4 toxicities were 86.9% and 18% in the combined-treatment group versus 77.8% and 9.5% with nivolumab alone.
These data will be featured today, June 5, during the Annual Meeting of the American Society of Clinical Oncology (ASCO) press briefing at 8:00 AM CDT and presented during an oral session from 10:12-10:24 AM CDT (Abstract LBA8507).
Arnaud Scherpereel, M.D., principal investigator of the study, head of the Pulmonary and Thoracic Oncology Department at the University Hospital (CHU) of Lille in France, stated: “For too long, patients with mesothelioma have been underserved in terms of treatment options compared with other types of cancers. The encouraging results of the previous IFCT trial, reported at the ASCO 2015 annual meeting, showed that when bevacizumab was used with the current standard-of-care combination of pemetrexed and cisplatin, it improved survival in patients with mesothelioma. Unfortunately, all patients in that study experienced disease progression. The results of IFCT-1501 MAPS-2 study, showing the efficacy and safety of nivolumab alone or in combination with ipilimumab, are promising, and additional research is needed for patients with relapsed mesothelioma.”
Nick Botwood, M.D., development lead, Thoracic Malignancies, Bristol-Myers Squibb, stated: “We would like to thank the researchers at IFCT, and the patients who participated in this important clinical trial. There has been little progress over the past decade in the treatment of malignant pleural mesothelioma, and for patients whose disease progresses following initial chemotherapy, there are limited data to guide subsequent treatment. The encouraging disease control rates seen in this study for nivolumab plus ipilimumab and nivolumab alone support further study of I-O therapy in mesothelioma. BMS is committed to continued research in thoracic cancers and is exploring the potential of I-O regimens for mesothelioma, with the hope of improving outcomes for patients with this rare, devastating disease.”
About IFCT-1501 MAPS-2
MAPS-2 is a Phase 2 multi-center randomized, non-comparative study evaluating nivolumab monotherapy and nivolumab plus ipilimumab combination therapy in patients with previously treated recurrent malignant pleural mesothelioma (MPM).
From March to August 2016, 125 patients were enrolled in 21 centers in France. Eligible patients, previously treated by 1 or 2 systemic chemotherapy lines, were randomized into two treatment groups: Patients received nivolumab (3 mg/kg every 2 weeks) or nivolumab (3 mg/kg every 2 weeks) combined with ipilimumab (1 mg/kg every 6 weeks) until progression or unacceptable toxicity.
The primary endpoint is disease control rate (DCR). Secondary endpoints include number of participants with treatment-related adverse events, progression-free survival, overall survival, quality of life, evaluation of predictive value of tumor PD-L1 score and prognostic value of biomarkers.
Rationale for immunotherapy in mesothelioma
MPM is a highly aggressive tumour. Asbestos exposure is the main factor involved in pathogenesis, which can explain the rise in incidence of mesothelioma patients since the 1960s (Bertazzi 2005, Goldberg 2006). Although mesothelioma is rare in the general population (prevalence in the non-exposed population <1 case/million individuals per year), around 100 cases per million per year in exposed individuals leads to an incidence between 900 and 1000 cases per year in France (Le Stang 2010, Cherié-Chaline 2012). Mesothelioma is a disease in which immune and inflammatory host response is thought to play a major role. Early data indicate that the combination of PD-1 and CTLA-4 receptor blockade may improve antitumor activity, and suggest further study to evaluate anti-PD-1 plus anti-CTLA-4 combination in MPM patients.
About the French Cooperative Thoracic intergroup (IFCT)
The IFCT is an independent, non-profit academic research intergroup specializing in thoracic oncology. Its objective is to improve survival and quality of life for thoracic cancer patients. Established in 1999, the IFCT has its own operational infrastructure and is equipped to design, promote, and carry out clinical studies in France and internationally, and to communicate the findings thus obtained. The IFCT’s activity regularly results in the introduction of new drugs or strategies that improve the efficacy, safety, and/or economic impact of anti-cancer therapies. This, in turn, leads to better patient management. All IFCT projects are coordinated by a Clinical Research Unit accredited by the National Cancer Institute (INCa) and the National League Against Cancer.
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 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 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 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.
SOURCE: Bristol-Myers Squibb
Post Views: 76
