Health Canada approves Tecentriq® (atezolizumab), first new treatment in 20 years for aggressive form of lung cancer

Friday, 16 August 2019 02:23.PM

- Data show Tecentriq in combination with carboplatin and etoposide helped patients with extensive-stage small cell lung cancer live longer, with a 30% reduction in the risk of death -

Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved Tecentriq® (atezolizumab) in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC), representing the first new treatment for the disease in more than two decades. Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line small cell lung cancer.

Lung cancer is the most commonly diagnosed cancer in Canada, with an average of 78 Canadians diagnosed every day. It is also the leading cause of death from cancer. SCLC is the most aggressive form of lung cancer, characterized by fast growing tumours and early metastasis, and accounts for approximately 15% of all lung cancer cases in Canada – the equivalent of 4,300 new patients each year. Of all new SCLC cases, two-thirds are diagnosed as extensive-stage. The prognosis for patients with ES-SCLC has historically been extremely bleak, with an estimated five-year survival rate of 3%.

"Atezolizumab in combination with chemotherapy provides a clinically meaningful improvement in overall survival when compared to chemotherapy alone, while most importantly improving quality of life for patients. This is an important milestone, since previously, there were limited treatments available," says Dr. Rosalyn Juergens, Associate Professor of Oncology at McMaster University. "The Health Canada approval of the Tecentriq regimen represents a new option and we are optimistic about the role it can play for this challenging to treat patient population in the future."

This approval is based on results from the Phase III IMpower133 study, which is the first Phase III study with an immunotherapy-based combination to show improvement in overall survival and progression-free survival in first-line treatment of ES-SCLC. The study showed that Tecentriq in combination with carboplatin and etoposide helped people live longer, compared with chemotherapy alone (median overall survival [OS] was 12.3 versus 10.3 months; hazard ratio [HR] was 0.70; 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population, corresponding to an estimated 30% reduction in the risk of death. The 1-year overall survival rate was approximately 13% higher in the atezolizumab group than in the placebo group (51.7% vs. 38.2%). Median progression free survival [PFS] was 5.2 months versus 4.3 months; HR was 0.77; 95% CI:0.62-0.96; p=0.017.

"The unmet need in small cell lung cancer is very high as the majority of patients are diagnosed at a late stage," says Shem Singh, Executive Director Lung Cancer Canada. "New treatment options are needed and the approval of atezolizumab provides a new tool for Canadians living with small cell lung cancer to manage the disease and spend more time with their families."