Bristol-Myers Squibb's Opdivo (nivolumab) receives expanded FDA approval in previously-treated metastatic non-small cell lung cancer (NSCLC)

Bristol-Myers SquibbBristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis.(1) The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7).1 This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.(2)

Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; and embryofetal toxicity.(1) Please see the Important Safety Information section below.

"Improving survival for cancer patients represents the ultimate goal of treatment," said Murdo Gordon, senior vice president and head of Worldwide Markets, Bristol-Myers Squibb. "With today's FDA approval, it is encouraging to know that Opdivo will be available to significantly more patients with metastatic NSCLC, helping to improve treatment outcomes for patients who have been previously treated. We hope that our efforts to bring innovative Immuno-Oncology treatments forward for patients will help increase survivorship and positively impact the lung cancer community."

This approval is the third for Opdivo in the United States this year, and is based on the results of the CheckMate -057 trial, a Phase 3 trial which demonstrated superior OS benefit for Opdivo vs. docetaxel in previously treated metastatic NSCLC. Opdivo is the only PD-1 therapy to have been studied in a Phase 3 trial of patients with previously treated squamous NSCLC and a separate Phase 3 trial of patients with previously treated non-squamous NSCLC. Biomarker testing is not required for Opdivo.

"Non-small cell lung cancer is a difficult to treat disease with high mortality, and patients with squamous and non-squamous NSCLC often respond differently to treatment," said Dr. Roy Herbst, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven. "Opdivo is becoming an important treatment option for more patients with previously treated metastatic NSCLC, and is a welcome addition to our therapy of this disease."

Proven Superior Overall Survival Versus Docetaxel in Metastatic NSCLC<3br> CheckMate -057 is a landmark, comparative study designed with the goal of demonstrating survival. Clinical results from CheckMate -057 were recently presented at the 2015 European Cancer Congress with simultaneous publication in the New England Journal of Medicine. CheckMate -057 is a Phase 3, open-label, randomized clinical trial that evaluated Opdivo (3 mg/kg administered intravenously every two weeks) (n=292) vs. docetaxel (75 mg/m2 administered intravenously every three weeks) (n=290), in patients with metastatic non-squamous NSCLC who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen. Appropriate targeted therapy may have been given to patients with known EGFR mutation or ALK translocation.(1) This study included patients regardless of their PD-L1 (programmed death ligand-1) expression status. The primary endpoint of this trial was OS.(1)

The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7).(1) The hazard ratio (HR) was 0.73 (95% CI: 0.60, 0.89; p=0.0015), which translates to a 27% reduction in the risk of death with Opdivo compared to docetaxel.(1) The prespecified interim analysis was conducted when 413 events were observed (93% of the planned number of events for final analysis).(1) Additional secondary endpoints include investigator-assessed objective response rate (ORR) and progression-free survival (PFS). The ORR in the Opdivo arm was 19% (56/292; 4 complete responses, 52 partial responses) (95% CI: 15, 24) and 12% with docetaxel (36/290; 1 complete response, 35 partial responses) (95% CI: 9, 17) p=0.02. The median duration of response was 17 months in the Opdivo arm and 6 months in the docetaxel arm. Median PFS was 2.3 months in the Opdivo arm vs. 4.2 months with docetaxel; HR=0.92 (95% CI:0.77, 1.11, p=0.39).

"With today's announcement, Opdivo represents the only PD-1 inhibitor approved for patients regardless of PD-L1 expression, and offers significant improvement over the current standard chemotherapy," said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. "Through our leadership in Immuno-Oncology research, we have taken a comprehensive approach to better understanding and treating metastatic NSCLC, with a primary focus on patients who are in need of new options. We are committed to building upon the promise that Opdivo has demonstrated for patients and providing a potential survival benefit in devastating diseases, like metastatic NSCLC."

The safety profile of Opdivo in CheckMate -057 was consistent with prior studies. Serious adverse reactions occurred in 47% of patients receiving Opdivo. The most frequent serious adverse reactions in at least 2% of patients receiving Opdivo were pneumonia, pulmonary embolism, dyspnea, pleural effusions and respiratory failure. Opdivo was discontinued in 13% of patients and was delayed in 29% of patients for an adverse reaction. The most common adverse reactions (reported in ≥20% of patients) were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%) and constipation (23%).(1)

"The approval of Opdivo for patients with previously treated metastatic NSCLC represents a major advancement in the way we are able to address the unmet needs of these patients, especially for those who have progressed on prior treatment and, until now, may have had limited options," said Andrea Ferris, president and chairman of LUNGevity Foundation. "Bristol-Myers Squibb has shown unwavering commitment to improving survival expectations for patients with metastatic NSCLC and I applaud their work, along with the FDA, in making this treatment option available to more patients."

Bristol-Myers Squibb has partnered with Dako, an Agilent Technologies company, to develop PD-L1 IHC 28-8 PharmDx, a test which was used to assess PD-L1 expression in the CheckMate -057 trial. This test is now approved by the FDA as a complementary diagnostic, which will provide additional information for physicians. These tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for Opdivo.

About Lung Cancer
Lung cancer is one of the leading causes of cancer deaths in the United States.2 NSCLC is one of the most common types of the disease and accounts for approximately 85% to 90% of lung cancer cases.(2) Squamous NSCLC accounts for approximately 25% to 30% of all lung cancer cases, while non-squamous NSCLC accounts for approximately 45% to 60% of all lung cancer cases.(2) Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV NSCLC, the five-year survival rate is one percent.(2)

About Bristol-Myers Squibb’s Patient Support Programs for Opdivo
Bristol-Myers Squibb remains committed to helping patients through treatment with Opdivo. For support and assistance, patients and physicians may call 1-855-OPDIVO-1. This number offers one-stop access to a range of support services for patients and healthcare professionals alike.

About Bristol-Myers Squibb’s Access Support
Bristol-Myers Squibb is committed to helping patients access Opdivo and offers numerous programs to support patients and providers in gaining access. BMS Access Support®, the Bristol-Myers Squibb Reimbursement Services program, is designed to support access to BMS medicines and expedite time to therapy through reimbursement support including Benefit Investigations, Prior Authorization Facilitation, Appeals Assistance, and assistance for patient out-of-pocket costs. BMS Access Support assists patients and providers throughout the treatment journey – whether it is at initial diagnosis or in support of transition from a clinical trial.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., 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.

1. Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October 9, 2015. Princeton, NJ: Bristol-Myers Squibb Company.
2. American Cancer Society Web site. “Detailed Guideline: Lung Cancer (Non-Small Cell).” Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed on September 15, 2015.

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