Bristol-Myers Squibb's immunotherapy Opdivo™ (nivolumab) approved by Health Canada for the treatment of previously untreated BRAF V600 wild-type metastatic melanoma

Priority review approval marks another milestone for Canadians living with this disease

MONTREAL, Sept. 25, 2015 /CNW/ - Bristol-Myers Squibb continues to lead with advances in immuno-oncology with the latest approval by Health Canada of Opdivo™ (nivolumab) for metastatic melanoma.  Opdivo is the first anti PD-1 (programmed death-1) approved to treat previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma in adults. The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies.

The CheckMate-066 phase 3 study was stopped early when an independent data review showed evidence of superior overall survival in patients receiving Opdivo over chemotherapy treatment dacarbazine (DTIC). The one-year survival rate was 73 per cent for those on Opdivo compared to 42% for DTIC. Those on Opdivo had a 58% decrease in the risk of death based on a hazard ratio of 0.42 (99.79% CI, 0.25-0.73; p<0.0001).

"The pioneering science that led to the introduction of the first immunotherapy to treat a very deadly form of cancer dramatically changed not only the way advanced melanoma is managed but also the outcome.  Today, we now have the option to offer newly diagnosed patients an anti PD-1 therapy.  This seems like the natural next step in a disease area that has transformed significantly to the benefit of our patients," said Dr. Michael Smylie, an oncologist specializing in melanoma at the Cross Cancer Institute in Edmonton. "Extending survival is a reality and the study results we've seen with Opdivo are very encouraging.  This approval is yet another very important step forward."

Metastatic melanoma should not be underestimated.  It is the deadliest form of skin cancer and represents 8% of all cases of skin cancer in Canada but accounts for 70% of deaths from the disease. Immunotherapy advances are positively impacting outcomes for patients.

"We are now seeing progress and the benefit of tremendous research in the treatment of metastatic melanoma. It is an amazing turning point for those of us who had previously despaired about treatment options and offering real hope to patients," said Annette Cyr, Chair and Founder of the Melanoma Network of Canada. "The rapid advances in immuno-oncology, as shown by this newest treatment approval, are very encouraging and we hope public payers will move quickly to complete their evaluations and make Opdivo available to all Canadian patients."

"In just a short period metastatic melanoma went from being defined as a deadly disease to a disease with people who are surviving. This approval is more than just another new treatment, it's someone's opportunity to live a longer life," said Kathy Barnard, Founder of the Save Your Skin Foundation and herself a survivor of metastatic melanoma. "The results of the ongoing research are giving patients treatment options and that's remarkable.  I'm here today witnessing history being made.  In fact, I'm living proof of it."

Transforming cancer care
The transformation of cancer care in metastatic melanoma began in 2012 with the approval by Health Canada of the immunotherapy, Yervoy^® (ipilimumab).  It was the first approved treatment proven to extend survival for patients with living with this deadliest form of skin cancer.  Yervoy was developed by Bristol-Myers Squibb who is leading advances in immuno-oncology and will continue to pursue its potential to improve long-term survival in melanoma and also in a broad range of other cancers.

"The approval of Opdivo is the beginning of another new exciting chapter for Bristol-Myers Squibb in immuno-oncology. Bristol-Myers Squibb is pleased to be able to offer an important new option for patients suffering from metastatic melanoma. We are very proud to have been part of the science behind Yervoy because it brought Canadian patients hope. Opdivo builds on our legacy in melanoma and marks another pivotal milestone for people living with this disease," said Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada.  "Bristol-Myers Squibb is passionate about helping patients prevail over serious diseases and changing the way patients live with advanced cancers. As a company we are leading the way with advances in immuno-oncology with the ultimate goal to improve long term survival in a broad range of other cancers."

About CheckMate-066
The Phase 3 CheckMate-066 study is a randomized, double-blind study comparing Opdivo (n=210) to the chemotherapy dacarbazine (DTIC) (n=208) in BRAF V600 wild-type patients with treatment-naïve advanced melanoma. It is the first Phase 3 trial of a PD-1 immune checkpoint inhibitor to demonstrate superior overall survival (OS) in advanced melanoma, demonstrating a one-year survival rate of 73% for Opdivo versus 42% for DTIC. There was a 58% decrease in the risk of death for patients treated with Opdivo based on a hazard ratio of 0.42 (99.79% CI, 0.25-0.73; P<0.0001). Objective response rate (ORR) also was significantly higher for Opdivo than DTIC (40% vs. 14%, P<0.0001).

The safety of Opdivo was also evaluated in CheckMate-066. Fewer discontinuations were observed with Opdivo than DTIC (6.8% vs. 11.7%) as well as for treatment-related Grade 3/4 adverse events (AEs) (11.7% vs. 17.6%), which were managed using established safety algorithms. The most common Opdivo treatment-related AEs were fatigue (19.9%), pruritus (17.0%), rash (15.0%), diarrhea (16.0%) and nausea (16.5%). Common adverse events in the DTIC arm were consistent with those in previous reports and included nausea (41.5%), vomiting (21.0%), fatigue (14.6%), diarrhea (15.6%) and hematological toxicities. No deaths were attributed to study drug toxicity in either arm.

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.

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

Opdivo has been approved for the treatment of metastatic melanoma in the United States for adults who have been previously treated with and progressed on Yervoy and, if BRAF mutated, Yervoy and a BRAF inhibitor and is also approved in the European Union and Japan. It has also been approved in the US and European Union for the treatment of metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumour types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.

Metastatic melanoma in Canada
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease, and occurs when cancer spreads beyond the surface of the skin to the other organs, such as the lymph nodes, lungs, brain or other areas of the body. An estimated 6,800 Canadians will be diagnosed with melanoma in 2015 and 1,150 will die from it. Melanoma accounts for 3% of all cancer diagnoses in Canada, making it one of the top 10 cancers diagnosed in Canada.  The incidence of melanoma has been increasing significantly in Canada during the past several decades. Between 2001 and 2010, incidence increased 2.3% per year for men and 2.9% per year for women.

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.

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 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.

Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb Company.

SOURCE Bristol-Myers Squibb Canada

For further information: Monica Flores, Public Affairs Lead, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]; Aislinn Mosher, Public Affairs Manager, Canada, Bristol-Myers Squibb Canada, 514-333-2530, [email protected]; Jean Kanan, Spectrum Advisors Communications Inc., 514-234-4095, [email protected]