ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb (BMS) has a robust clinical development program in Opdivo monotherapy and in combination therapy with other therapeutic drugs in a variety of tumor types overseas, including Head and Neck Cancer, Glioblastoma, Small Cell Lung Cancer, Urothelial Cancer, Hepatocellular Carcinoma, Esophageal Cancer, Hodgkin Lymphoma, Colorectal Cancer, Solid Tumors (Triple-Negative Breast Cancer, Gastric Cancer, Pancreatic Cancer), Blood Cancer, etc.
In Japan, Ono Pharmaceutical Co., Ltd. (ONO) launched Opdivo for the treatment of unresectable melanoma in September 2014. ONO received an approval for additional indication of unresectable, advanced or recurrent non-small cell lung cancer in December 2015. In addition, ONO has submitted supplemental applications for additional indications of Renal Cell Cancer and Hodgkin Lymphoma, and is conducting clinical development program including Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Glioblastoma, Ovarian Cancer, Urothelial Cancer, Biliary Tract Cancer, etc.
In Japan, ONO and BMS (and BMS Japan subsidiary BMSKK) have formed a strategic partnership that includes co-development, co-commercialization, and co-promotion of multiple immunotherapies for patients with cancer.
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
Opdivo is the first and only PD-1 inhibitor to demonstrate a statistically significant improvement in overall survival compared to three standard of care options in this setting, based on CheckMate -141
Data from CheckMate -141 showed survival benefit with Opdivo in this overall population, regardless of PD-L1 expression or HPV status
Safety of Opdivo in CheckMate -141 was consistent with prior studies, with no new safety signals identi- fied
(PRINCETON, NJ, April 19, 2016) - Bristol-Myers Squibb Company (NYSE: BMY) announced today the first presentation of data from CheckMate -141, a Phase 3 open-label, randomized trial, evalu- ating Opdivo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum therapy compared to investigator's choice of therapy (methotrexate, docetaxel, or cetuximab). In the trial, which evaluated overall survival (OS) as the primary endpoint, patients treat- ed with Opdivo experienced a 30% reduction in the risk of death, with a median OS of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator's choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101). The one-year survival rate for Opdivo was 36% compared to 16.6% for investiga- tor's choice. The safety profile of Opdivo in CheckMate -141 was consistent with prior studies, with no new safety signals identified.
These data were featured today, Tuesday, April 19, during the 2016 Annual Meeting of the American Association for Cancer Research (AACR) official press program at 8:30 A.M. CT and will be presented during the Immuno-Oncology Clinical Trials II Plenary Session from 10:30 A.M. - 12:15
P.M. CT.
Maura Gillison, M.D., Ph.D., lead investigator, Jeg Coughlin Chair of Cancer Research, The Ohio State University Wexner Medical Center, commented, "Squamous cell carcinoma of the head and neck that progresses after platinum-therapy is a devastating disease with a very poor prognosis. There are no systemic therapies that improve survival, and therefore, there is a tremendous unmet need for new treatment options for this patient population. In CheckMate -141, Opdivo demonstrated an improvement
in survival compared to three standard of care options in this overall patient population, regardless of PD-L1 expression levels and HPV status."
Based on a planned interim analysis, this trial was stopped early in January 2016 because an as- sessment conducted by the independent Data Monitoring Committee concluded the study met its prima- ry endpoint of OS in patients receiving Opdivo compared to the control arm.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, comment- ed, "We are excited to share, for the first time, data from the CheckMate -141 trial with the oncology community at the 2016 AACR Annual Meeting. We are encouraged by the overall survival results seen with this investigational use of Opdivo versus three standard of care options for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who often face poor survival rates. These findings are supportive of our Immuno-Oncology research goal to study potential treatment options for their ability to help patients with difficult-to-treat cancers achieve long-term survival."
About CheckMate -141
CheckMate -141 is a Phase 3, open-label, randomized trial evaluating Opdivo versus investigator's choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum therapy in the adjuvant, primary, recurrent or metastatic setting. Patients were randomized 2:1 to receive Opdivo 3 mg/kg intravenously over 60 minutes every two weeks, or one of the following single agents: methotrextate 40 mg/m2 intravenously weekly, docetaxel 30 mg/m2 intra-
venously weekly, or cetuximab 400 mg/m2 intravenously once then 250 mg/m2 weekly. Therapies cho-
sen for the control arm represent the most commonly used therapies in the platinum refractory setting. The primary endpoint was OS. Secondary endpoints included objective response rate (ORR) and pro- gression-free survival (PFS). Additional endpoints included safety.
In the trial, patients treated with Opdivo experienced a significant reduction (30%) in the risk of death, with a median OS of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for the control arm (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101). The one-year OS rate was 36% for Opdi- vo compared to 16.6% for the control arm.
CheckMate -141 also evaluated the efficacy of Opdivo by HPV status and PD-L1 expression compared to investigator's choice of therapy. HPV testing was performed for patients identified by in- vestigators with oropharyngeal tumors. In the study, Opdivo demonstrated improved survival in this overall population, regardless of HPV status. HPV-positive status was associated with greater magnitude of effect with Opdivo versus investigator's choice. In HPV-positive patients treated with Opdivo, medi-
an OS was 9.1 months vs. 4.4 months for patients treated with investigator's choice of therapy (HR=0.56 [95% CI: 0.32-0.99]). In HPV-negative patients treated with Opdivo, median OS was 7.5 months vs. 5.8 months for patients treated with investigator's choice of therapy (HR=0.73 [95% CI: 0.42-1.25])
Of randomized patients, 72% (260) were evaluable for PD-L1 expression. Rates of PD-L1 ex- pression were balanced between subgroups. Opdivo demonstrated improved survival in the overall population, regardless of PD-L1 expression level (chart below).
Hazard Ratio (HR) for Opdivo vs. Investigator's Choice Therapy (Median OS, mos) | |
>1% PD-L1 expression level | HR=0.55 [95% CI: 0.36-0.83] 8.7 mos vs. 4.6 mos (95% CI: 5.7-9.1) (95% CI: 3.8-5.8) |
HR=0.89 [95% CI: 0.54-1.45] 5.7 mos vs. 5.8 mos (95% CI: 4.4-12.7) (95% CI: 4.0-9.8) |
The safety profile of Opdivo in CheckMate -141 was consistent with prior studies with no new safety signals identified. Treatment-related adverse events (TRAEs) of any grade occurred in 58.9% of patients on Opdivo vs. 77.5% of patients on investigator's choice. Grade 3-4 TRAEs were reported in 13.1% of patients on Opdivo vs. 35.1% of patients on investigator's choice. Two drug-related deaths were reported as related to Opdivo (pneumonitis and hypercalcemia), and one Grade 5 event of lung in- fection on the investigator's choice arm.
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 re- ported as less than 4% for metastatic Stage IV disease. Squamous cell carcinoma of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol con- sumption, 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
ONO Pharmaceutical Co. Ltd. issued this content on 21 April 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 21 April 2016 07:15:24 UTC
Original Document: http://www.ono.co.jp/eng/news/pdf/sm_cn160421.pdf
