Bristol-Myers Squibb Canada Release: Canada's Health Technology Assessment Agency Gives Positive Recommendation For OPDIVO To Treat Non-Small Cell Lung Cancer

OPDIVO is the first immuno-oncology therapy for lung cancer in Canada to use the body's own immune system to fight cancer

MONTREAL, June 8, 2016 /CNW/ - Canada's national health technology assessment body (CADTH) today made its final, positive recommendation for OPDIVO (nivolumab) for the treatment of non-small cell lung cancer (NSCLC), a reflection of the strong clinical evidence that supports the benefits of this immuno-oncology treatment of adult patients with advanced or metastatic NSCLC who progressed on or after chemotherapy.¹

The CADTH evaluation of the clinical, economic, and patient evidence of OPDIVO for the treatment of NSCLC was made under the pan-Canadian Oncology Drug Review (pCODR) process.

"We are so pleased to have a positive recommendation from this expert committee," said Alain Boisvert, Vice-President, Market Access & Public Affairs, Bristol-Myers Squibb Canada. "Our aim is to provide accessible solutions that help Canadian patients face serious diseases. To receive a positive recommendation from one of the world's leading drug assessment organizations validates the strength of the clinical evidence demonstrating the value of OPDIVO for offering more hope to lung cancer patients."

"Ongoing efforts to provide patients with more treatments is critical," said Shem Singh, Executive Director of Lung Cancer Canada. "The announcement represents an important milestone and we encourage the provinces to provide much-needed access to this therapy for lung cancer patients who desperately need more options. Patients deserve the chance to live longer and spend precious quality time with their friends and families."

Based on the positive recommendation, Bristol-Myers Squibb Canada will continue to collaborate with federal, provincial and territorial authorities to ensure Canadian adults have access to OPDIVO for the treatment of advanced or metastatic NSCLC as quickly as possible.

In just over eight months, OPDIVO has received Health Canada approval as a treatment for three distinct tumour types, including metastatic NSCLC, metastatic melanoma and advanced or metastatic renal cell carcinoma (RCC). The OPDIVO Health Canada submissions received priority reviews after meeting the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. The OPDIVO lung and melanoma phase 3 studies were stopped early for demonstrating superior overall survival in patients receiving OPDIVO versus standard of care.

About Bristol-Myers Squibb Canada

Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, 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's global operations, visit www.bms.com. Bristol-Myers Squibb Canada has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

Additional Information:
As a PD-1 immune checkpoint inhibitor, OPDIVO works by activating the immune system to fight and kill the tumour by blocking the interaction between the tumour's PD-1 ligands and T-cells' PD-1 receptors, in order to reactivate the anti-tumor response.² It represents an important treatment advancement for lung cancer patients in Canada. OPDIVO is the only PD-1 inhibitor approved for previously treated metastatic NSCLC patients.

The following information is available on the Canadian Agency for Drugs and Technologies in Health (CADTH) website at www.cadth.ca, including:

• The pERC Final Recommendation, with a detailed discussion of how the recommendation was made
• The clinical and economic guidance reports used by pERC during its deliberation
• Feedback on the pERC Final Recommendation submitted by the manufacturer, by the Patient Advocacy Group and by the pCODR Provincial Advisory Group (PAG).

About OPDIVO
Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumour from immune attack. OPDIVO is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.2

The recommended dose of OPDIVO is 3 mg/kg administered intravenously over 60 minutes every two weeks.² Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.

OPDIVO was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 46 countries, including the United States, Japan and in the European Union. In Canada, OPDIVO is indicated for the treatment of adult patients:

• With locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving OPDIVO),
• With unresectable or metastatic BRAF V600 wild-type melanoma who have been previously untreated.
• With RCC, a form of kidney cancer who have received prior anti-angiogenic therapy in the advanced or metastatic setting.

Bristol-Myers Squibb has a broad, global development program to study OPDIVO in multiple tumour types in which more than 18,000 patients have been enrolled worldwide.

Systematic Review Evidence¹
The pCODR systematic review included two randomized, open-label, phase 3 studies comparing nivolumab to Docetaxel in adult patients with non-squamous or squamous NSCLC who have progressed during or after platinum-based doublet chemotherapy. Generally, baseline characteristics were balanced between the two groups in the two studies.

• CheckMate 057 (non-squamous) enrolled patients with a median age of 62 and who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 (31%) or 1 (69%). The trial eligibility criteria did not allow patients with an ECOG PS >1. Patients enrolled in the study also had stage IV disease (92%) and were mostly current or former smokers (79%) with a minority who had never smoked (20%). Patients were eligible for the trial if brain metastases have been treated and were stable. EGFR mutation positivity was present in 14% of patients, ALK mutation in 4% and KRAS mutation in 11% of patients.
• CheckMate 017 (squamous) enrolled patients with a median age of 63 and who had an ECOG PS of 0 (24%) or 1 (76%). The trial eligibility criteria did not include patients with an ECOG PS >1 or patients with untreated CNS metastases. Patients enrolled in the study also had stage IV cancer (80%), were current or former smokers (92%), and were mostly white (93%). Driver mutation status was not reported in the trial.

Immuno-oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease. To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body's immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different pathways in the treatment of cancer. Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.

References
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¹ pCODR Expert Review Committee (pERC) Initial Recommendation.  https://www.cadth.ca/sites/default/files/pcodr/nivolumab_opdivo_nsclc_fn_rec.pdf. Accessed June 2016.
² Bristol-Myers Squibb Canada Co. OPDIVO Canadian Product Monograph, Revised: April 2016.

SOURCE Bristol-Myers Squibb Canada