Confirmed objective response rate was 24.4% in these previously treated patients who received Opdivo
Similar response rates were observed regardless of PD-L1 expression status; in patients with PD-L1 <1%, the objective response rate was 26.8%, and in patients with PD-L1 ≥1%, the objective response rate was 24%
At one year, patients treated with Opdivo had an overall survival rate of 45.6%, with a median overall survival of more than nine months
PRINCETON, NJ, USA I June 5, 2016 I Bistol-Myers Squibb Company (NYSE:BMY) announced today the first presentation of results for Opdivo in the cohort of patients with metastatic urothelial cancer (n=78), the most common type of bladder cancer, after platinum-based therapy from CheckMate -032, a Phase 1/2 open-label trial. In the trial, the primary endpoint of investigator-assessed confirmed objective response rate (ORR), was 24.4% (95% CI: 15.3-35.4) in patients treated with Opdivo, with a minimum follow-up of nine months. Response rates by tumor PD-L1 expression, evaluated as an exploratory endpoint, were similar regardless of PD-L1 expression levels. In patients with PD-L1 <1%, the ORR was 26.8%, and in patients with PD-L1 ≥1%, the ORR was 24%. At one year, patients treated with Opdivo had an overall survival (OS, a secondary endpoint) rate of 45.6%, with a median OS of 9.72 months (95% CI: 7.26-16.16). The safety profile of Opdivo in CheckMate -032 was consistent with the known safety profile of Opdivo in other tumor types.
These data will be presented today, Sunday, June 5, at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in an oral abstract session from 8:12 AM – 8:24 AM CDT (Abstract #4501).
Padmanee Sharma, M.D., Ph.D., study investigator and professor at The University of Texas MD Anderson Cancer Center, commented, “Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. Patients with advanced stages of the disease face high rates of disease recurrence and progression, making new research an extremely important factor to address this high unmet medical need. We are pleased with the findings from the Phase 1/2 study, CheckMate -032, which provide support for further study of Opdivo in patients with this cancer to assess outcomes and survival.”
Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year. The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and progression are high, and approximately 78% of patients will experience a recurrence within five years. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV bladder cancer, the five-year survival rate is 15%.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, “We are excited to present for the first time results for Opdivo in previously treated metastatic urothelial cancer, a type of bladder cancer. We are encouraged by the response rates and overall survival data observed with Opdivo in CheckMate -032, which supports the ongoing Phase 2 study in this cancer. Through our Immuno-Oncology research across different tumor types, our goal is to help more patients achieve quality long-term survival, and we look forward to further study of our Immuno-Oncology agents, including the Opdivo and Yervoy combination, in advanced bladder cancer.”
About CheckMate -032
CheckMate -032 is an ongoing Phase 1/2 open-label trial, evaluating the safety and efficacy of Opdivo monotherapy, or Opdivo combined with Yervoy in advanced or metastatic solid tumors. The trial enrolled patients regardless of PD-L1 expression. The primary endpoint was investigator-assessed confirmed objective response rate (ORR). Secondary endpoints included safety, duration of response, overall survival (OS) and progression-free survival (PFS).
Data presented at ASCO specific to metastatic or locally advanced urothelial cancer were from a cohort of 78 patients who have received one or more prior lines of platinum-based therapy. In this analysis, patients received Opdivo monotherapy (3 mg/kg administered intravenously every two weeks) until progression or discontinuation. Patients treated with Opdivo monotherapy were allowed to continue treatment beyond progression if Opdivo was tolerated and clinical benefit was noted, or patients could cross over to receive the combination of Opdivo and Yervoy if they met prespecified criteria.
In the trial, the investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3-35.4) for the cohort of patients treated with Opdivo. Median duration of response was not estimable (9.92-NE). In addition, the one-year OS rate reported for the Opdivo-cohort was 45.6%, based on Kaplan-Meier estimates, with a median OS of 9.72 months (95% CI: 7.26-16.16). Median PFS was 2.78 months (95% CI: 1.45-5.85).
Of randomized patients, 67 patients had quantifiable tumor PD-L1 expression, with 37.3% expressing PD-L1 at ≥1%. Objective response rate was 26.8% (14.2-42.9) in patients with PD-L1 <1%, and 24% (9.4-45.1) in patients with PD-L1 ≥1%. Efficacy of Opdivo by PD-L1 expression was an exploratory endpoint in CheckMate -032.
The safety profile of Opdivo in CheckMate -032 was consistent with the known safety profile of Opdivo in other tumor types. Grade 3-4 treatment-related adverse events (AEs) occurred in 22% of patients receiving Opdivo, with the most frequent AEs of any grade reported in ≥10% of patients being fatigue (36%), pruritus (30%), maculopapular rash (18%), increased lipase (14%), nausea (13%), arthralgia (12%), and anemia (10%). Two Grade 5 treatment-related AEs occurred in patients treated with Opdivo (pneumonitis [n=1] and thrombocytopenia [n=1]). No Grade 3 or 4 pneumonitis or thrombocytopenia was reported.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These pathways may lead to potential new treatment options – in combination or monotherapy – to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large biotech companies, to research the potential of Immuno-Oncology and non-Immuno-Oncology combinations, helps achieve our goal of providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.
About Opdivo
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system, including the interference with an anti-tumor immune response.
Opdivo’s broad global development program is based on Bristol-Myers Squibb’s understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression. To date, the Opdivo clinical development program has enrolled more than 18,000 patients.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 51 countries including the United States, Japan, and in 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 wild-type unresectable or metastatic melanoma.
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 confirmatory trials.
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 post- transplantation brentuximab vedotin. 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.
Please refer to the end of the Important Safety Information for a brief description of the patient populations studied in the Checkmate trials.
CHECKMATE Trials and Patient Populations
Checkmate 069 and 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 057 – non-squamous non-small cell lung cancer (NSCLC); Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma
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: 57
Confirmed objective response rate was 24.4% in these previously treated patients who received Opdivo
Similar response rates were observed regardless of PD-L1 expression status; in patients with PD-L1 <1%, the objective response rate was 26.8%, and in patients with PD-L1 ≥1%, the objective response rate was 24%
At one year, patients treated with Opdivo had an overall survival rate of 45.6%, with a median overall survival of more than nine months
PRINCETON, NJ, USA I June 5, 2016 I Bistol-Myers Squibb Company (NYSE:BMY) announced today the first presentation of results for Opdivo in the cohort of patients with metastatic urothelial cancer (n=78), the most common type of bladder cancer, after platinum-based therapy from CheckMate -032, a Phase 1/2 open-label trial. In the trial, the primary endpoint of investigator-assessed confirmed objective response rate (ORR), was 24.4% (95% CI: 15.3-35.4) in patients treated with Opdivo, with a minimum follow-up of nine months. Response rates by tumor PD-L1 expression, evaluated as an exploratory endpoint, were similar regardless of PD-L1 expression levels. In patients with PD-L1 <1%, the ORR was 26.8%, and in patients with PD-L1 ≥1%, the ORR was 24%. At one year, patients treated with Opdivo had an overall survival (OS, a secondary endpoint) rate of 45.6%, with a median OS of 9.72 months (95% CI: 7.26-16.16). The safety profile of Opdivo in CheckMate -032 was consistent with the known safety profile of Opdivo in other tumor types.
These data will be presented today, Sunday, June 5, at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in an oral abstract session from 8:12 AM – 8:24 AM CDT (Abstract #4501).
Padmanee Sharma, M.D., Ph.D., study investigator and professor at The University of Texas MD Anderson Cancer Center, commented, “Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. Patients with advanced stages of the disease face high rates of disease recurrence and progression, making new research an extremely important factor to address this high unmet medical need. We are pleased with the findings from the Phase 1/2 study, CheckMate -032, which provide support for further study of Opdivo in patients with this cancer to assess outcomes and survival.”
Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year. The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and progression are high, and approximately 78% of patients will experience a recurrence within five years. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV bladder cancer, the five-year survival rate is 15%.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, “We are excited to present for the first time results for Opdivo in previously treated metastatic urothelial cancer, a type of bladder cancer. We are encouraged by the response rates and overall survival data observed with Opdivo in CheckMate -032, which supports the ongoing Phase 2 study in this cancer. Through our Immuno-Oncology research across different tumor types, our goal is to help more patients achieve quality long-term survival, and we look forward to further study of our Immuno-Oncology agents, including the Opdivo and Yervoy combination, in advanced bladder cancer.”
About CheckMate -032
CheckMate -032 is an ongoing Phase 1/2 open-label trial, evaluating the safety and efficacy of Opdivo monotherapy, or Opdivo combined with Yervoy in advanced or metastatic solid tumors. The trial enrolled patients regardless of PD-L1 expression. The primary endpoint was investigator-assessed confirmed objective response rate (ORR). Secondary endpoints included safety, duration of response, overall survival (OS) and progression-free survival (PFS).
Data presented at ASCO specific to metastatic or locally advanced urothelial cancer were from a cohort of 78 patients who have received one or more prior lines of platinum-based therapy. In this analysis, patients received Opdivo monotherapy (3 mg/kg administered intravenously every two weeks) until progression or discontinuation. Patients treated with Opdivo monotherapy were allowed to continue treatment beyond progression if Opdivo was tolerated and clinical benefit was noted, or patients could cross over to receive the combination of Opdivo and Yervoy if they met prespecified criteria.
In the trial, the investigator-assessed confirmed ORR was 24.4% (95% CI: 15.3-35.4) for the cohort of patients treated with Opdivo. Median duration of response was not estimable (9.92-NE). In addition, the one-year OS rate reported for the Opdivo-cohort was 45.6%, based on Kaplan-Meier estimates, with a median OS of 9.72 months (95% CI: 7.26-16.16). Median PFS was 2.78 months (95% CI: 1.45-5.85).
Of randomized patients, 67 patients had quantifiable tumor PD-L1 expression, with 37.3% expressing PD-L1 at ≥1%. Objective response rate was 26.8% (14.2-42.9) in patients with PD-L1 <1%, and 24% (9.4-45.1) in patients with PD-L1 ≥1%. Efficacy of Opdivo by PD-L1 expression was an exploratory endpoint in CheckMate -032.
The safety profile of Opdivo in CheckMate -032 was consistent with the known safety profile of Opdivo in other tumor types. Grade 3-4 treatment-related adverse events (AEs) occurred in 22% of patients receiving Opdivo, with the most frequent AEs of any grade reported in ≥10% of patients being fatigue (36%), pruritus (30%), maculopapular rash (18%), increased lipase (14%), nausea (13%), arthralgia (12%), and anemia (10%). Two Grade 5 treatment-related AEs occurred in patients treated with Opdivo (pneumonitis [n=1] and thrombocytopenia [n=1]). No Grade 3 or 4 pneumonitis or thrombocytopenia was reported.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.
We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents, and continue to study the role of combinations in cancer.
We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These pathways may lead to potential new treatment options – in combination or monotherapy – to help patients fight different types of cancers.
Our collaboration with academia, as well as small and large biotech companies, to research the potential of Immuno-Oncology and non-Immuno-Oncology combinations, helps achieve our goal of providing new treatment options in clinical practice.
At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.
About Opdivo
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system, including the interference with an anti-tumor immune response.
Opdivo’s broad global development program is based on Bristol-Myers Squibb’s understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology to extend survival in hard-to-treat cancers. This scientific expertise serves as the basis for the Opdivo development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. The Opdivo trials have also contributed toward the clinical and scientific understanding of the role of biomarkers and how patients may benefit from Opdivo across the continuum of PD-L1 expression. To date, the Opdivo clinical development program has enrolled more than 18,000 patients.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 51 countries including the United States, Japan, and in 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 wild-type unresectable or metastatic melanoma.
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 confirmatory trials.
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 post- transplantation brentuximab vedotin. 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.
Please refer to the end of the Important Safety Information for a brief description of the patient populations studied in the Checkmate trials.
CHECKMATE Trials and Patient Populations
Checkmate 069 and 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 057 – non-squamous non-small cell lung cancer (NSCLC); Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma
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: 57
