China National Drug Administration Approves Country’s First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC)

China National Drug Administration Approves Country’s First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC)

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the China National Drug Administration (CNDA) has approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This is China’s first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase 3 CheckMate -078 trial, in which 90% of the patients enrolled were Chinese.

“Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country,” said Professor Yi-Long Wu, a tenured director of Guangdong General Hospital and the chair of the Chinese Thoracic Oncology Group. “With most lung cancer patients already at an advanced stage when diagnosed, prolonging survival is an important goal. The approval of Opdivo as the first I-O agent in China is a significant therapeutic advance and is great news for patients and clinicians alike, offering for the first time an I-O treatment option that is proven to extend survival in predominantly Chinese patients with previously treated NSCLC.”

The approval is based on results from the Phase 3 CheckMate -078 trial of Opdivo versus chemotherapy among patients with previously treated NSCLC, findings from which were presented at the American Association for Cancer Research Annual Meeting in April 2018. In November 2017, the trial was stopped early because the independent Data Monitoring Committee concluded that Opdivo demonstrated superior overall survival compared with chemotherapy. The application later received priority review by the Center for Drug Evaluation in China.

Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb, commented, “With approvals in more than 60 countries, Opdivo is a global standard of care for previously treated NSCLC, and we are proud to bring this foundational I-O treatment option to patients and physicians in China. We look forward to continuing to work together with the CNDA to usher in additional healthcare innovations in China, with our shared commitment to moving quickly to help patients.”

In CheckMate -078, Opdivo reduced the risk of death by 32% versus chemotherapy, the primary endpoint (HR 0.68; 97.7% CI: 0.52 to 0.90; p=0.0006), in patients with previously treated NSCLC. Both efficacy and safety of Opdivo in this patient population were consistent with the results of the landmark global CheckMate -017 and -057 studies. In CheckMate -078, Grade 3-4 treatment-related adverse events (TRAEs) occurred less frequently with Opdivo versus docetaxel (10% vs. 48%). Discontinuations due to Grade 3-4 TRAEs were also less frequent with Opdivo (3%) than with docetaxel (5%).

“We are thrilled to be able to bring this proven treatment, Opdivo, which has demonstrated superior overall survival versus chemotherapy in previously treated NSCLC patients in China, and are committed to working with stakeholders to ensure patients can quickly access Opdivo,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “With more than 7,500 cancer deaths per day estimated in China, we will continue to work with urgency to integrate the unmet treatment needs of Chinese patients in our ongoing I-O global development program, with the goal of bringing them innovative therapies as quickly as possible.”

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 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) without EGFR mutations and with both squamous and non-squamous NSCLC, across PD-L1 expression status of <1% and ≥1%, to receive either Opdivo 3 mg/kg intravenously every two weeks (N=338) or docetaxel 75 mg/m2 intravenously every three weeks (N=166) until documented disease progression or unacceptable toxicity.

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

Minimum follow-up was 8.8 months. Median OS was 12.0 months in the Opdivo arm and 9.6 months in the chemotherapy arm (HR 0.68; 95% CI: 0.52 to 0.90; p=0.0006). Improved OS with Opdivo versus docetaxel was observed in patients with squamous (HR 0.61; 95% CI: 0.42 to 0.89) and non-squamous (HR 0.76; 95% CI: 0.56 to 1.04) tumor histology, and across all pre-defined subgroups based on tumor PD-L1 expression level. The hazard ratios in patients with tumor PD-L1 expression ≥1% and <1% were 0.62 (95% CI: 0.45 to 0.87) and 0.75 (95% CI: 0.52 to 1.09), respectively. The ORR was 17% with Opdivo versus 4% with docetaxel. Median duration of response was not reached in the Opdivo arm versus 5.3 months in the docetaxel arm. Opdivo decreased risk of disease progression by 23% versus docetaxel (HR 0.77; 95% CI: 0.62 to 0.95; p=0.0147).

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. Non-small cell lung cancer (NSCLC) is one of the most common types of the disease and accounts for approximately 85% of diagnoses. There are approximately 781,000 new cases of lung cancer diagnosed in China each year, equaling approximately 15 new cases every 10 minutes. This number continues to rise, with more than 800,000 new cases and 700,000 new deaths projected by 2020. Survival rates vary depending on the stage and type of the cancer when diagnosed, with the five-year survival rate lower than 5%. For patients with advanced squamous cell lung cancer and non-squamous NSCLC without any known driver genetic mutation, treatment measures are quite limited. Therefore, long-term survival is the most urgent need of those patients.

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 medicines, including Immuno-Oncology (I-O) therapeutic approaches, for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the integrated scientific understanding of both tumor cell and immune system pathways, 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. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions through their journey.

We understand making the promise of transformational medicines like I-O therapies 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.

JUNE 18, 2018


June 19, 2018 / Pharma News
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