Health Canada approves OPDIVO™ (nivolumab) for the treatment of advanced or metastatic non-small cell lung cancer

OPDIVO™ is the first and only immuno-oncology therapy in lung cancer in Canada, which uses the body's own immune system to fight cancer, offering improved survival to more patients

MONTREAL, March 1, 2016 /CNW/ - Health Canada has approved OPDIVO™ (nivolumab) injection, the first and only immuno-oncology therapy (anti PD-1 agent) approved in Canada 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.¹ Immuno-oncology (I-O) uses the body's own immune system to fight cancer cells.

"With the introduction of immuno-oncology, we are venturing into an exciting, new time in cancer care," said Dr. Rosalyn Juergens, Assistant Professor of Oncology, McMaster University, and medical oncologist, Juravinski Cancer Centre. "The approval of OPDIVO™ is the first sign of hope for the lung cancer community as the results are unprecedented in both the quantity and quality of survival rates. We are seeing durable and well-tolerated responses, and this completely changes the game for treating lung cancer."

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 data to support the approval was based on CheckMate -017 and CheckMate -057 trials and both phase three trials were stopped early when an independent data review showed evidence of superior overall survival in patients receiving OPDIVO™ over chemotherapy treatment.

OPDIVO™ has now been approved in two distinct tumour types within the last five months in Canada. It was first approved in September 2015 for the treatment of adult patients with metastatic BRAF V600 wild-type melanoma.

Lung cancer is one of the most commonly diagnosed cancers in Canada and is the leading cause of death.² With a five-year survival rate of just 17 per cent,³ and less than one per cent for stage IV,⁴ the discovery of new medications for long-term survival had been limited. NSCLC represents approximately 85 – 90 per cent of lung cancer cases.⁵

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.⁶ 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.

For Lorne Cochrane, 56, from Alberta, learning he had stage IV lung cancer was devastating news. Like many, Lorne's late diagnosis was due to the fact he showed no symptoms — his diagnosis was a result of follow-up with his physician after his twin brother was diagnosed with stage I lung cancer. However, two years ago Lorne started receiving OPDIVO™ through a clinical trial, and despite a dismal prognosis, he continues to live life to its fullest with a good quality of life.

"When you are given a late stage cancer diagnosis, you know your options and chances for survival are limited," said Lorne. "My life changed when I got the call to be part of the clinical trial. Today, I want others living with lung cancer to know that hope is on the horizon — I am proof of that."

About CheckMate -017 and CheckMate -057      
The results of the CheckMate -017 trial demonstrated superior overall survival in previously treated metastatic, squamous-cell NSCLC compared to chemotherapy, with a 41 per cent reduction in the risk of death. The OPDIVO™ treated patients lived 3.2 months longer, with the median OS at 9.2 months in the OPDIVO™ arm (95 per cent CI: 7.3, 13.3) and 6.0 months in the docetaxel arm (95 per cent CI: 5.1, 7.3). A one year OS rate showed survival was almost double of that compared to chemotherapy (docetaxel), 42 per cent (n=135, 95 per cent confidence interval (CI) = 34-50) vs 24 per cent (n=137, 95 per cent CI =17-31).⁷ In the CheckMate -057 trial, OPDIVO™ demonstrated superior overall survival in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27 per cent reduction in the risk of death. OPDIVO™-treated patients lived 2.8 months longer, with the median OS at 12.2 months in the OPDIVO™ arm (95 per cent CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95 per cent CI: 8.0, 10.7). The overall survival rate at one year was 51 per cent (95 per cent CI, 45 to 56) with OPDIVO™ and 39 per cent (95 per cent CI, 33 to 45) with docetaxel.⁸ Treatment-related adverse events (AEs) occurred less frequently with OPDIVO™ than docetaxel. The most frequently reported drug-related AEs (occurring at ≥10 per cent) was fatigue (26.0 per cent), nausea (11 per cent), rash (11 per cent) and decreased appetite (11 per cent) in patients treated with OPDIVO™.

"This announcement is welcome news to lung cancer patients who desperately need more options. It gives patients the chance to live longer and spend precious quality time with their friends and families." said Shem Singh, Executive Director of Lung Cancer Canada. "The approval of OPDIVO™ is significant and offers real hope."

NSCLC is often not found until it is at an advanced stage, which can make it somewhat more difficult to treat, and decreases survival.⁴

"We are seeing some great results from innovations in the treatment of advanced cancers," said Jackie Manthorne, president and CEO, Canadian Cancer Survivor Network. "I-O treatments have transformed the treatment paradigm for people with metastatic melanoma and now for lung cancer patients. We are excited to see the potential of I-O across different tumour types."

"The Health Canada approval of OPDIVO™ will offer hope for longer survival to more patients suffering from metastatic non-small cell lung cancer," said Dr. Nawal Peacock, president and general manager, Bristol-Myers Squibb Canada Co. "With OPDIVO™ now approved as a treatment in melanoma and lung cancer, Bristol-Myers Squibb Canada is the leader in immuno-oncology in advanced cancers in Canada. We would like to sincerely thank the patients and physicians who participated in the OPDIVO™ clinical trials."  

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™ 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™ (nivolumab) is approved by Health Canada for adult patients for following indications:

• 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™),
• Unresectable or metastatic BRAF V600 wild-type melanoma who have been previously untreated.ⁱ

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. 

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on immuno-oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy, and targeted therapies for certain types of cancer.

We have a comprehensive clinical portfolio of investigational and approved immuno-oncology agents, many of which were discovered and developed by our scientists. Our ongoing immuno-oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two immuno-oncology agents, and continue to study the role of combinations in cancer.

We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, CSF1R, IDO, and LAG-3. These pathways may lead to potential new treatment options – in combination or monotherapy – to help patients fight different types of cancers.

Our collaboration with academia, as well as small and large biotech companies, is responsible for researching the potential immuno-oncology and non-immuno-oncology combinations, with the goal of providing new treatment options in clinical practice.

At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.

About Bristol-Myers Squibb Canada Co.
Bristol-Myers Squibb Canada Co. 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 Co. 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 Co. employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

References:

¹ Bristol-Myers Squibb Canada Co. OPDIVO™ Canadian Product Monograph, Revised: February 23, 2016.

² Lung Cancer Statistics. Canadian Cancer Society.  http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on#ixzz3sQTjkjLL. Accessed November 23, 2015.

³ Lung Cancer Canada. The Faces of Lung Cancer Report, November 2015. http://www.lungcancercanada.ca/getmedia/7f1ad2f4-2bb0-45e8-9bf5-d4fa01779a68/The-Faces-of-Lung-Cancer-2015.aspx. Accessed November 23, 2015.

⁴ Survival statistics for non–small cell lung cancer. Canadian Cancer Society. http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/survival-statistics/?region=on#ixzz3sQXOfvEN. Accessed November 23, 2015.

⁵ What is non-small cell lung cancer? American Cancer Society. http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed November 23, 2015.

⁶ Bristol-Myers Squibb Canada Co. OPDIVO™ Canadian Product Monograph, Revised: February 23, 2016.

⁷ Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373:123-135.

⁸ Borghaei H, Paz‑Ares L, Horn L, Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer N Engl J Med. 2015; 373:1627-1639.

SOURCE Bristol-Myers Squibb Canada

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