Opdivo™ (nivolumab) demonstrates superior survival compared to standard of care (docetaxel) for previously-treated squamous non-small cell lung cancer in phase 3 trial

• Opdivo is the first major treatment advance in more than a decade for this disease, showing superior one-year overall survival rate of 42% versus 24% for docetaxel 

MONTREAL, June 3, 2015 /CNW/ - A new Bristol-Myers Squibb immunotherapy, Opdivo™ (nivolumab), demonstrated a superior one-year overall survival rate of 42% versus 24% for the standard of care, docetaxel, in previously treated patients with advanced, squamous non-small cell lung cancer.  The results from CheckMate -017, a phase 3, open-label randomized study, were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and simultaneously published in the New England Journal of Medicine.

In the trial, 135 patients received Opdivo and 137 docetaxel. Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59 (95% CI, 0.44-0.79; P = 0.00025). The median overall survival was 9.2 months for Opdivo versus 6 months for docetaxel. The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favourable versus docetaxel.

"These encouraging study results are a major advance in the treatment of squamous non-small cell lung cancer in more than a decade," said Dr. Barbara Melosky, Associate Professor of Medicine, UBC and Medical Oncologist, BC Cancer Agency, Vancouver. "This is an important development in treating a disease in which treatment options are very limited and long-term survival rates still far too low, particularly compared to most other cancers."

Opdivo demonstrated a consistent statistically significant superiority over docetaxel across all secondary endpoints including overall response rate and progression-free survival. Results showed that, at one year, Opdivo improved progression-free survival (21%) versus docetaxel (6.4%). Median progression-free survival was 3.5 months for Opdivo and 2.8 months for docetaxel, with a hazard ratio of 0.62 (95% CI, 0.47-0.81; P = 0.0004). Opdivo also produced a significantly higher confirmed objective response rate (20%) versus docetaxel (8.8%) (95% CI; P=0.0083). Responses for Opdivo were ongoing and the median duration of response was not reached (range 2.9 to 21+ months) with at least 11 months of follow-up; the median duration of response for docetaxel was 8.4 months (range 1.4+ to 15+ months).

"The reality is that lung cancer survival lags behind other major cancers. There is such a vast and critical unmet need that must be addressed in order to deal with this deadliest of cancers," said Shem Singh, Executive Director of Lung Cancer Canada. "Research in this area is vital because of the potential impact it has on survival. Promising new research brings hope to patients and their families who may currently find themselves with few options. This announcement is tremendous news for the lung cancer community."

The safety and efficacy of Opdivo for squamous non-small cell lung cancer is still under investigation in Canada.

About CheckMate -017
CheckMate -017 was a Phase III, open-label, randomized clinical trial that evaluated Opdivo 3 mg/kg intravenously over 60 minutes every two weeks versus standard of care, docetaxel 75 mg/m2 intravenously administered every 3 weeks in patients with advanced squamous non-small cell lung cancer who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The study's primary endpoint was overall survival and secondary endpoints including progression-free survival and response rate. The trial included patients regardless of their PD-L1 (programmed death ligand-1) expression status.

Of randomized patients in the trial (n=272), 83% (225) had quantifiable PD-L1 expression. Rates of PD-L1 positivity were balanced between treatment groups. Across pre-specified expression levels (1%, 5%, and 10%), Opdivo demonstrated superior benefit across all endpoints independent of PD-L1 expression. Overall and progression-free survival among PD-L1 subgroups favored Opdivo and was similar to the primary population. Similar objective response rates were observed in patients with high and low, or no PD-L1 expression, and were consistently higher for Opdivo versus docetaxel.

The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. Treatment-related adverse events occurred less frequently with Opdivo (any grade, 58%; grade 3–4, 6.9%; no grade 5 events) than docetaxel (any grade, 86%; grade 3–4, 55%; grade 5, 2.3%), including both hematologic and non-hematologic toxicities. 

Lung cancer in Canada
More than one in every 12 Canadians will get lung cancer. It is the most common cancer among those that affect both men and women,ⁱ with more than 26,000 cases diagnosed in 2014.ⁱⁱ Lung cancer is by far the leading cause of cancer deaths in Canada, in both men and women. It caused 20,500 deaths in 2014 – 27% of all cancer deaths.ⁱⁱⁱ  A Canadian dies of lung cancer every 27 minutes. Despite treatment advances, the five-year survival rate for lung cancer in Canada is among the lowest for all cancers at just 17%, higher only than the rates for cancer of the esophagus (14%) and pancreas (8%).^iv Rates of lung cancer vary between men and women and different regions of Canada, being highest in Quebec and lowest in British Columbia.^v While smoking is the leading cause of lung cancer, half of patients are not smoking at the time of diagnosis: 15% are lifelong non-smokers and 35% more are ex-smokers, many who quit years before.^vi 

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.

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ⁱ Canadian Cancer Society, Canadian Cancer Statistics, Lifetime probability of developing cancer overall and by age group, Canada, 2009, p. 23.
ⁱⁱ Canadian Cancer Society, Canadian Cancer Statistics, Estimated new cases and age-standardized incidence rates (ASIR) for cancers by sex, Canada, 2014, p. 24.
ⁱⁱⁱ Canadian Cancer Society, Canadian Cancer Statistics, Estimated deaths and age-standardized mortality rates (ASMR) for cancers by sex, Canada, 2014, p. 45.
^iv Canadian Cancer Society, Canadian Cancer Statistics, Five-year relative and observed survival for selected cancers by sex, ages 15–99 years at diagnosis, Canada (excluding Quebec*), 2006–2008, p. 64.
^v Canadian Cancer Society, Canadian Cancer Statistics, Estimated age-standardized incidence rates (ASIR) for selected cancers by sex and province, Canada, 2014, p. 36.
^vi Lung Cancer Canada, The Faces of Lung Cancer: Fighting Disparity, p. 4, accessed at: http://www.lungcancercanada.ca/resources/site1/general/Reports%20and%20Media%20Releases/Faces%20of%20Lung%20Cancer%20Report.pdf

SOURCE Bristol-Myers Squibb Canada

Monica Flores, Public Affairs Lead, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]; Jean Kanan, President and Principal Advisor, Spectrum Advisors, 514-234-4095, [email protected]