CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival

Opdivo demonstrates superior overall survival compared to docetaxel in patients with previously treated advanced non-small cell lung cancer

First I-O agent to show survival benefit in Chinese population, based on a Phase 3 study

China Food and Drug Administration accepted the marketing application for Opdivo

PRINCETON, NJ, USA I November 30, 2017 I Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Phase 3 study CheckMate -078, evaluating Opdivo (nivolumab) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC), was stopped early because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared with the control arm. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. CheckMate -078 is a multinational Phase 3 study with predominantly Chinese patients. The Company submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration (CFDA) for the proposed indication of previously treated NSCLC, which has been accepted by the CFDA.

Prof. Yi-Long Wu, a tenured professor of the Guangdong Lung Cancer Institute and the Guangdong General Hospital, chair of the Chinese Thoracic Oncology Group (CTONG) and the principal investigator of CheckMate -078, commented, “It is exciting to see that the Phase 3 CheckMate -078 study met its primary endpoint early, which confirmed, for the first time, a superior overall survival benefit with a PD-1 inhibitor, nivolumab, in Chinese patients, compared with the standard treatment, docetaxel. Based on the topline results, nivolumab has the potential to become the first Immuno-Oncology (I-O) treatment approved for previously treated lung cancer patients in China, and I hope that Chinese patients with NSCLC can benefit from this groundbreaking I-O treatment as early as possible.”

Nick Botwood, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, “The results of CheckMate -078 mark the third time Opdivo has demonstrated a survival advantage in previously treated metastatic non-small cell lung cancer. In China, where lung cancer is the leading cause of cancer death, these results are especially important, as they represent the first Phase 3 trial to show an overall survival benefit with a PD-1 inhibitor in the Chinese patient population. Through our Opdivo clinical development program, we aim to bring the potential for long-term survival to patients where significant unmet medical needs remain.”

The company will evaluate the CheckMate -078 data and work with investigators on the future presentation and publication of the results.

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 with both squamous and non-squamous NSCLC (451 from China, 45 from Russia, 8 from Singapore) to receive either Opdivo 3mg/kg intravenously every two weeks or docetaxel 75 mg/m2 every three weeks intravenously until documented disease progression or unacceptable toxicity. The primary endpoint is overall survival (OS). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), time to treatment failure (TTF), efficacy across subgroups, rates of treatment-related adverse events (AEs) and rate of disease-related symptom deterioration measured by the lung cancer symptom scale (LCSS).

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 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’ 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, governments, 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 adults 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.

Checkmate Trials and Patient Populations
Checkmate 067 - advanced melanoma alone or in combination with YERVOY; 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.

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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