Opdivo (nivolumab), First PD-1 Inhibitor to Demonstrate Superior Survival Benefit Compared with Chemotherapy in a Predominantly Chinese Population with Previously Treated Non-Small Cell Lung Cancer (NSCLC)

In the Phase 3 CheckMate -078 trial, Opdivo reduced the risk of death by 32% versus chemotherapy

Objective response rates quadrupled with Opdivo (17%) versus docetaxel (4%); median duration of response not reached with Opdivo versus 5.3 months with docetaxel

Efficacy and safety of Opdivo in a predominantly Chinese patient population with advanced NSCLC were consistent with the results of the global CheckMate -017 and -057 studies

PRINCETON, NJ, USA I April 13,2018 I Bristol-Myers Squibb Company (NYSE: BMY) today announced results from the pivotal, randomized Phase 3 CheckMate -078 trial evaluating Opdivo (nivolumab) versus docetaxel in a predominantly Chinese population with previously treated advanced non-small cell lung cancer (NSCLC). In the study, Opdivo demonstrated a statistically significant benefit versus docetaxel on the primary endpoint of overall survival (OS; HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006). An OS benefit was observed regardless of PD-L1 expression or tumor histology. Additionally, the two secondary endpoints of objective response rate (ORR) and median duration of response (mDOR) demonstrated durability with Opdivo compared with docetaxel (ORR: 17% vs. 4%; mDOR: not reached vs. 5.3 months, respectively).

Findings will be presented on Monday, April 16 from 4:05-4:20 PM CDT during the Updates in Immuno-Oncology Trials session at the American Association for Cancer Research (AACR) Annual Meeting 2018 in Chicago (Abstract #CT114).

Prof. Yi-Long Wu, principal investigator of CheckMate -078, commented, “The prevalence of lung cancer in China continues to rise, and the disease remains a leading cause of cancer death. Results from CheckMate -078, in which approximately 90% of the patients are from China, are groundbreaking, as they show for the first time an immunotherapy, Opdivo, can significantly improve outcomes across key endpoints, including overall survival, compared with chemotherapy, representing a potential new approach for these patients.”

In November 2017, the Company announced that the China Food and Drug Administration had accepted the Biologics License Application for Opdivo for the proposed indication of previously treated NSCLC.

Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, said, “Opdivo is the only PD-1 inhibitor to have demonstrated an overall survival benefit versus chemotherapy in three randomized Phase 3 lung cancer studies. The positive findings from CheckMate -078 are consistent with the landmark global studies CheckMate -017 and -057, which led to Opdivo becoming a standard of care in most of the world for previously treated squamous and non-squamous NSCLC, and represent our commitment to bring transformational medicines to patients worldwide.”

In CheckMate -078, Grade 3-4 treatment-related adverse events (TRAEs) occurred less frequently with Opdivo versus docetaxel (10% vs 47%). Discontinuation due to Grade 3-4 TRAEs were less frequent with Opdivo (3%) than with docetaxel (5%).

Additional Data from CheckMate -078 at AACR 2018

Additional data presented at AACR 2018 include progression-free survival with Opdivo versus docetaxel. In the study, Opdivo decreased risk of disease progression by 23% versus chemotherapy (HR 0.77; 95% CI: 0.62, 0.95; p=0.0147).

In addition, subgroup analyses by tumor histology and PD-L1 expression levels showed Opdivo extended OS versus docetaxel. In patients with squamous NSCLC, the hazard ratio (HR) for OS was 0.61 (95% CI: 0.42 to 0.89), and in patients with non-squamous NSCLC, the HR was 0.76 (95% CI: 0.56 to 1.04). In patients whose tumors expressed PD-L1 <1% and ≥1%, the HRs for OS were 0.75 (95% CI: 0.52 to 1.09) and 0.62 (95% CI: 0.45 to 0.87), respectively.

About CheckMate -078

CheckMate -078 is a Phase 3, multinational, randomized study comparing Opdivo with docetaxel in the treatment of patients with Stage IIIb/IV non-small cell lung cancer (NSCLC) whose disease has progressed after platinum-based doublet chemotherapy. The study was conducted primarily in China, with additional study sites in Hong Kong, Russia and Singapore. The trial randomized 504 patients (451 from China, 45 from Russia, 8 from Singapore) with both squamous and non-squamous NSCLC and across PD-L1 expression status of <1% and ≥1% to receive either Opdivo 3mg/kg intravenously every two weeks (N=338) or docetaxel 75 mg/m2 every three weeks intravenously (N=166) until documented disease progression or unacceptable toxicity.

The primary endpoint is overall survival (OS), including OS consistency observed in the global studies CheckMate -017 and CheckMate -057. Secondary endpoints include objective response rate, progression-free survival, time to treatment failure, efficacy across subgroups, rates of treatment-related adverse events and rate of disease-related symptom deterioration measured by the Lung Cancer Symptom Scale.

About CheckMate -057 and -017

CheckMate -057 and CheckMate -017 are two separately conducted global Phase 3 studies that evaluated the survival of patients with non-squamous NSCLC (-057) and squamous NSCLC (-017) who had progressed during or after one prior platinum doublet-based chemotherapy regimen.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally, resulting in nearly 1.7 million deaths each year, according to the World Health Organization. In China, lung cancer is the most commonly diagnosed cancer, with more than 733,000 cases diagnosed in 2015. In addition, 68% of lung cancer patients in China are already at an advanced stage when diagnosed. NSCLC is one of the most common types of the disease and accounts for approximately 85% of diagnoses. About 25% to 30% of all lung cancers are squamous cell carcinomas, and non-squamous NSCLC accounts for approximately 50% to 65% of all lung cancer diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed.

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 advancing 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 24 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. Through our leading translational capabilities, we are pioneering immune biology research and identifying a number of potentially predictive biomarkers, including PD-L1, TMB, MSI-H/dMMR and LAG-3, advancing the possibility of precision medicine for more patients with cancer.

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 contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and 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 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 the confirmatory trials.

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

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 adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. 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.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. 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 adult and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. 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 hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. 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 adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (10 mg/mL) is an injection for intravenous (IV) use.

Checkmate Trials and Patient Populations

Checkmate 067–advanced melanoma alone or in combination with YERVOY® (ipilimumab); Checkmate 037 and 066–advanced melanoma; Checkmate 017–squamous non-small cell lung cancer (NSCLC); Checkmate 057–non-squamous NSCLC; Checkmate 025–renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

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

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