ONO PHARMACEUTICAL CO., LTD. February 2, 2016
(PRINCETON, NJ, January 28, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) announced that a randomized Phase 3 study evaluating Opdivo (nivolumab) versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.
In USA, Opdivo was approved under accelerated approval for the treatment of unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor in December 2014 and approved for the treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March 2015. Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma received the approval in October 2015. Also, Opdivo received expanded FDA approval in previously- treated metastatic non-small cell lung cancer in the same month. Furthermore, Opdivo was approved for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy, and for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma as a single agent in November 2015. In EU, Opdivo was approved for the treatment of advanced (unresectable or metastatic) melanoma in adults regardless of BRAF status in June 2015.
European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in July 2015.
Also, BMS has a robust clinical development program in a variety of tumor types overseas, including: Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Urothelial Cancer, etc. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. ONO was approved for the treatment of patients with unresectable, advanced or recurrent NSCLC in December 2015. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Hodgkin Lymphoma, Urothelial Cancer, Glioblastoma, Ovarian Cancer, etc. In Japan, ONO and Bristol Myers KK are co-promoting Opdivo.
Attached from the following page is the press release made by BMS for your information.
Contact
ONO PHARMACEUTICAL CO., LTD.
Corporate Communications public_relations@ono.co.jp
CheckMate -141, a Pivotal Phase 3 Opdivo (nivolumab) Head and Neck Cancer Trial, Stopped Early
Opdivo Study Demonstrates Superior Overall Survival Compared to Therapy of Investigator's Choice in Patients with Recurrent or Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck
(PRINCETON, NJ, January 28, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) today announced that a randomized Phase 3 study evaluating Opdivo (nivolumab) versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.
"With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer."
CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data and work with investigators on the future presentation and publication of the results.
About CheckMate -141
CheckMate -141 is a Phase 3, open-label, randomized study of Opdivo versus investigator's choice of therapy in previously treated patients with SCCHN who have tumor progression on or within 6 months of platinum therapy in the primary, recurrent, or metastatic setting. The trial randomized 361 patients 2:1 to receive either nivolumab 3 mg/kg intravenously every two weeks or investigator's choice (cetuximab/methotrexate/docetaxel) until documented disease progression or
unacceptable toxicity. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression free survival.
About Head & Neck Cancer
Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five year survival rate is reported as less than four percent for metastatic Stage IV disease. SCCHN accounts for approximately 90 percent of all head and neck cancers with global incidence expected to increase by 17 percent between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption and the increasing role of Human Papilloma Virus (HPV) infection leading to rapid increase in oropharyngeal SCCHN in Europe and North America. Quality of life is often impacted for SCCHN patients as physiological function (breathing, swallowing, eating, drinking), personal characteristics (appearance, speaking, voice), sensory function (taste, smell, hearing), and psychological/social function can be effected.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Modern 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 is responsible for researching the potential Immuno-Oncology and non-Immuno-Oncology combinations, with the 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 46 countries including the United States, Japan, and in the European Union.
INDICATIONS
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) 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
ONO Pharmaceutical Co. Ltd. issued this content on 02 February 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 02 February 2016 07:25:15 UTC
Original Document: http://www.ono.co.jp/eng/news/pdf/sm_cn160202_02.pdf
