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June 6, 2016

Long-Term Survival and Improvement in Quality of Life Observed with Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma Patients Based on New Data Presented at the 2016 ASCO Annual Meeting

(PRINCETON, NJ, June 5, 2016) - Bristol-Myers Squibb (NYSE: BMY) announced new long- term overall survival (OS) results from two dose-ranging studies, the Phase 1 CA209-003 study and the Phase 2 CA209-010 study, evaluating Opdivo in patients with previously treated advanced renal cell carcinoma (RCC). Findings include the first report of four- and five-year survival data from the advanced RCC cohort (n=34) of study -003, in which overall survival (OS) was an exploratory endpoint. In study -003, 38% of patients were alive at four years, and 34% of patients were alive at five years. In study -010 (n=167), in which OS was a secondary endpoint, 29% of patients were alive at four years. The long-term safety profile of Opdivo in studies -003 and -010 was consistent with previously reported studies, with no new safety signals identified after more than four years of follow-up.

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.

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ONO PHARMACEUTICAL CO., LTD.

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Long-Term Survival and Improvement in Quality of Life Observed with Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma Patients Based on New Data Presented at the 2016 ASCO Annual Meeting

More than one-third (34%) of previously treated advanced renal cell carcinoma patients who received

Opdivo were alive at five years, in the Phase 1 study¸CA209-003

In the Phase 2 study, CA209-010, 29% of previously treated advanced renal cell carcinoma patients who received Opdivo were alive at four years

Improved health-related quality of life observed with Opdivo, versus everolimus, based on pivotal Phase 3 study, CheckMate -025

(PRINCETON, NJ, June 5, 2016) - Bristol-Myers Squibb Company (NYSE: BMY) announced today new long-term overall survival (OS) results from two dose-ranging studies, the Phase 1 CA209- 003 study and the Phase 2 CA209-010 study, evaluating Opdivo in patients with previously treated advanced renal cell carcinoma (RCC). Findings include the first report of four- and five-year survival data from the advanced RCC cohort (n=34) of study -003, in which overall survival (OS) was an exploratory endpoint. In study -003, 38% of patients were alive at four years, and 34% of patients were alive at five years. In study -010 (n=167), in which OS was a secondary endpoint, 29% of patients were alive at four years. The long-term safety profile of Opdivo in studies -003 and -010 was consistent with previously reported studies, with no new safety signals identified after more than four years of follow-up.

Bristol-Myers Squibb is also presenting additional analyses of health-related quality of life data, a secondary endpoint, from the pivotal, Phase 3 study, CheckMate -025, which evaluated Opdivo versus everolimus in patients with advanced RCC who received prior anti-angiogenic therapy. In this study, 55.4% of patients treated with Opdivo experienced a clinically meaningful improvement in disease- related symptoms, as defined in the study, versus 36.7% of patients treated with everolimus (HR=1.66 [95% CI: 1.33-2.08; p

Dr. Bernard Escudier, Chair of the Genitourinary Oncology Committee, Institut Gustave Roussy in Villejuif, France, commented, "Historically, five-year survival rates for patients diagnosed with advanced kidney cancer have been less than 12%. Building on the survival results seen in the Phase 3 study, CheckMate -025, research evaluating whether Opdivo may provide long-term survival has been of interest to physicians. Data from studies -003 and -010 report, for the first time, longer than four-year

survival with Opdivo in previously treated advanced renal cell carcinoma. These findings offer additional important information about the role of Opdivo as a treatment option for these patients."

The results from studies -003 and -010 will be presented today, Sunday, June 5, at the 52nd

Annual Meeting of the American Society of Clinical Oncology (ASCO) during an oral presentation from 10:24 AM - 10:36 AM CDT (Abstract #4507). Data from CheckMate -025 will be presented during a poster session on Monday, June 6, from 1:00 PM - 4:30 PM CDT (Abstract #4549).

"We are excited to share the overall survival results from studies -010 and -003, as these data provide new insights into the long-term efficacy and safety of Opdivo in previously treated advanced renal cell carcinoma," said Vicki Goodman, M.D., Development Lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. "Additionally, with Opdivo, a meaningful improvement in health-related quality of life, an important factor in cancer care and patient well-being, was observed compared to everolimus, based on new data from CheckMate -025. We look forward to further evaluating our Immuno-Oncology agents across different tumor types, including the Opdivo and Yervoy combination, with the goal of improving long-term survival and quality of life for RCC patients."

About CA209-003

Study -003, is a Phase 1b open-label, multicenter, multidose, dose-escalation study

evaluating Opdivo in 306 patients with select advanced or recurrent malignancies. The primary endpoint was safety and tolerability. Secondary endpoints included objective response rate (ORR). Overall survival (OS) was an exploratory endpoint.

The results from study -003 presented at the 2016 ASCO Annual Meeting focus on the cohort of patients with advanced renal cell carcinoma (RCC, n=34) who had received one to five prior systemic therapies, and were treated with Opdivo 1 mg/kg or 10 mg/kg intravenously every two weeks.

At four years, the OS rate for patients treated with Opdivo was 38%, with a median OS of 22.4 months (95% CI: 12.5-NE), and the five-year survival rate was 34%, with a minimum follow-up of 50.5 months. The long-term safety profile of Opdivo in study -003 was consistent with previous studies, with no new safety signals identified after more than four years of follow-up. Grade 3-4 treatment-related adverse events (AEs) occurred in 17.6% of patients. Any grade treatment-related AEs leading to discontinuation occurred in 8.8% of patients.

About CA209-010

Study -010 is a Phase 2, randomized, dose-ranging study evaluating Opdivo in 167 patients with previously treated advanced renal cell carcinoma (RCC). In the study, patients with advanced RCC who

had received prior treatment with one to three therapies (at least one being an anti-angiogenic agent) were treated with Opdivo (0.3, 2 or 10 mg/kg) every three weeks administered intravenously. The primary endpoint was dose-response by progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS) and safety.

At four years, the OS rate for patients treated with Opdivo was 29%, with a median OS of 23.4 months (95% CI: 17.7-26.9), at a minimum follow-up of 49.2 months. In the study, the ORR was 21.6% (95% CI: 15.6-28.6) with a median duration of response lasting 23 months. Median time to response was 2.8 months (1.2-10.0).

The long-term safety profile of Opdivo in study -010 was consistent with previous studies, with no new safety signals identified after approximately four years of follow-up. Grade 3-4 treatment-related adverse events (AEs) occurred in 14.4% of patients in study -010. Any grade treatment-related AEs leading to discontinuation occurred in 9.6% of patients.

About CheckMate -025

CheckMate -025 is an open-label, randomized Phase 3 study of Opdivo versus everolimus in previously treated patients with advanced clear-cell renal cell carcinoma (RCC) after prior anti- angiogenic therapy. Patients were randomized to receive Opdivo (n=410) 3 mg/kg administered intravenously every two weeks or everolimus (n=411) 10 mg administered orally once daily. The primary endpoint of the study was overall survival (OS). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), quality of life (QoL) and safety. Patient-reported QoL was measured using the kidney specific, Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) scale, and European Quality of Life (EuroQol)-5 Dimensions (EQ-5D) questionnaire. Quality of life was measured at baseline among approximately 361 patients randomized for treatment with Opdivo and 343 patients randomized for treatment with everolimus.

A higher proportion of patients treated with Opdivo experienced a clinically meaningful improvement in health-related QoL (defined as a 2-point increase from baseline using FKSI-DRS) compared to patients treated with everolimus (200 [55.4%] of 361 vs. 126 [36.7%] of 343, respectively; (HR=1.66 [95% CI: 1.33-2.08; pOpdivo and was not estimable with everolimus due to a limited number of patients who experienced improvement.

About Renal Cell Carcinoma

ONO Pharmaceutical Co. Ltd. published this content on 06 June 2016 and is solely responsible for the information contained herein.
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