ONO PHARMACEUTICAL : Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma (137KB)

June 19, 2017

(PRINCETON, NJ, June 16, 2017) - Bristol-Myers Squibb Company (NYSE: BMY) announced extended follow-up data in which Opdivo (nivolumab) demonstrated responses in adult patients with relapsed or progressed classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT), irrespective of brentuximab vedotin (BV) therapy history. Results from the Phase 2 CheckMate -205 study reflect the longest follow-up data of a programmed death 1 (PD-1) inhibitor in patients with cHL. These data will be presented tomorrow in an oral session at 8:45 AM CEST during the 14th International Conference on Malignant Lymphoma in Lugano, Switzerland.

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 glioblastoma, small cell lung cancer, urothelial cancer, hepatocellular carcinoma, esophageal cancer, colorectal cancer, gastric 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, unresectable or metastatic renal cell cancer in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016 and recurrent or metastatic head and neck cancer in March 2017. In addition, ONO has submitted supplemental application for additional indication of gastric cancer, and is conducting clinical development program including esophageal cancer, gastro-esophageal junction cancer, small cell lung cancer, hepatocellular carcinoma, glioblastoma, urothelial cancer, malignant pleural mesothelioma, ovarian 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.

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Results show overall response rates of 65% or greater with median follow-up of at least 16 months, regardless of prior brentuximab vedotin therapies

(PRINCETON, NJ, June 16, 2017) - Bristol-Myers Squibb Company (NYSE: BMY) today announced extended follow-up data in which Opdivo (nivolumab) demonstrated responses in adult patients with relapsed or progressed classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT), irrespective of brentuximab vedotin (BV) therapy history. Results from the Phase 2 CheckMate -205 study reflect the longest follow-up data of a programmed death 1 (PD-1) inhibitor in patients with cHL. These data will be presented tomorrow in an oral session at 8:45 AM CEST during the 14th International Conference on Malignant Lymphoma in Lugano, Switzerland.

The ongoing multi-cohort CheckMate -205 study evaluated objective response rates (ORR), the primary endpoint, as well as duration of response rates (DOR) for each cohort, all of which were assessed by the Independent Radiology Review Committee. In the BV-naïve group (Cohort A: n=63), with a median follow-up of 19 months, patients had an ORR of 65%, with a complete response (CR) in 29% of patients. The median DOR was 20 months and the median progression-free survival (PFS) was 18.3 months (95% CI: 11.1 to 22.4).

In the group that had BV therapy after ASCT (Cohort B: n=80), with a median follow-up of 23 months, the ORR was 68%, with CR in 13% of patients. The median DOR was 16 months and the median PFS was 14.7 months (95% CI: 10.5 to 19.6).

In the BV-before- (n=33), -after- (n=58) or before-and-after- (n=9) ASCT group (Cohort C: n=100 total), with a median follow-up of 16 months, the ORR was 73%, with CR in 12% of patients. The median DOR was 15 months and the median PFS was 11.9 months (95% CI: 11.1 to 18.4).

"Treatment options are limited for patients with classical Hodgkin Lymphoma after ASCT has failed, which is why the high objective response rates shown across cohorts of the CheckMate -205 study are encouraging," said Michelle Fanale, M.D., Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center. "The results are particularly welcome news, as patients experienced responses regardless of brentuximab

vedotin treatment history or the depth of their Hodgkin lymphoma's response to brentuximab vedotin."

Across cohorts, the median overall survival was not reached, and 40% of patients remained on treatment. The safety profile was consistent with previously reported data in this tumor type. The most common treatment-related adverse events (AEs) were fatigue (23%), diarrhea (15%), and infusion reactions (IRs; 14%). Grade 3

or 4 AEs experienced included fatigue (1%), diarrhea (1%) and rash (1%).

"These extended results across cohorts indicate that Opdivo may offer a potential treatment option for patients with classical Hodgkin Lymphoma progressing after ASCT," said Jonathan Leith, hematology development lead, Bristol-Myers Squibb.

The U.S. Food and Drug Administration and the European Medicines Agency first approved Opdivo for patients with relapsed or refractory (RR) cHL following ASCT and BV in 2016. In the U.S., the indication received 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.

About CheckMate -205

CheckMate -205 is an ongoing Phase 2, multi-cohort study evaluating Opdivo in adult patients with classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), irrespective of brentuximab vedotin (BV) therapy history. Patients enrolled in this trial were treated with Opdivo 3 mg/kg intravenously every two weeks until disease progression or unacceptable toxicity. There were 243 adult patients with RR cHL at trial entry and 77% of patients had stage III or greater RR cHL. At median follow-up between 16 and 23 months, 97 patients remained on treatment.

About Classical Hodgkin Lymphoma

Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. Worldwide, there are about 66,000 new HL cases and 25,500 deaths from HL estimated each year. The disease is most often diagnosed in early adulthood (ages 20-

40) and late adulthood (older than 55 years of age). Classical Hodgkin lymphoma (cHL) is the most common type of HL, accounting for 95% of cases. There remains a significant unmet need for patients who relapse or who become refractory to approved

treatments that are currently available, as the estimated five-year survival rate for patients in the U.S. with cHL diagnosed at stage III is 80%, and at stage IV, about 65%.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno- Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I- O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients' individual tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo's leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have