Media Release

Basel, 08 October 2019

Tecentriq (atezolizumab) by Roche is approved in Switzerland for patients with small cell lung cancer

  • Small cell lung cancer is distinguished from other lung cancer subtypes by its aggressive nature, rapid growth and early development of metastatic disease2
  • There have been no relevant advances in therapy for patients with this type of lung cancer for over 30 years3
  • The approval is based on the results of the IMpower133 study, the first Phase III study of a cancer immunotherapy that shows that an immunotherapy-based combination therapy significantly improves survival in first-line therapy of extensive-stage small cell lung cancer4

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Tecentriq® (atezolizumab) in combination with carboplatin and etoposide for first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC).1

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped patients live significantly better compared to chemotherapy only (median overall survival [OS] = 12.3 vs. 10.3 months; hazard ratio [HR] = 0.70, 95% CI: 0.54–0.91; p=0.0069).

This is the first Phase III study which shows that an immunotherapy-based combination treatment of cancer significantly improves overall survival and progression-free survival (PFS) of extensive stage small cell lung cancer in first-line therapy. The safety profile when combining Tecentriq with chemotherapy was consistent with the known safety profile of Tecentriq.4

"We are delighted by the approval of Tecentriq for small cell lung cancer. After more than 30 years, a cancer immunotherapy for this difficult to treat and extremely aggressive form of lung cancer is available for the first time in the form of Tecentriq, which can help patients to live longer», said Dr Oliver Bleck, General Manager of Roche Pharma (Switzerland).

Lung cancer is the leading cause of cancer death globally5. Each year in Switzerland, approx. 3,500 people die as a result of lung cancer (source: Globocan 2018), with SCLC accounting for approximately 15% of all lung cancer cases. The majority of patients with this subtype (70%) are diagnosed in the «extensive stage» of the disease, which generally means a worse prognosis. SCLC is distinguished from other lung cancer subtypes by its aggressive nature, rapid growth and early development of metastatic disease. 3

About the IMpower133 study

IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) vs. chemotherapy only (carboplatin and etoposide) in chemotherapy-naïve adults with ES-SCLC.
The study enrolled 403 people who were randomised equally (1:1) to receive:

  • Tecentriq in combination with carboplatin and etoposide (Arm A), or
  • Placebo in combination with carboplatin and etoposide (Group B, Control group).4

About Tecentriq (atezolizumab)

Tecentriq® is a monoclonal antibody, designed to bind with a protein called PD-L1 (programmed death-ligand 1) which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1 proteins on the surface of T cells, thereby inhibiting T cells. By inhibiting PD-L1, Tecentriq® may enable the activation of T cells and therefore has the potential to recognise and fight tumour cells.

About Roche in cancer immunotherapy

For more than 50 years, Roche has been developing drugs to set new therapy benchmarks in oncology. Today, Roche is investing more than ever in its endeavour to develop innovative treatment options that assist the patient's own immune system in fighting cancer.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned are protected by law.

References

  1. Product Information for TECENTRIQ® at www.swissmedicinfo.ch.
  2. Paglialunga L et al. Immune checkpoint blockade in small cell lung cancer: is there a light at the end of the tunnel? ESMO Open 2016;1:e000022.
  3. Sabari JK et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol 2017;14(9):549–561.
  4. Horn L et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018; DOI: 10.1056/NEJMoa1809064.
  5. GLOBOCAN 2018; Lung Cancer: Estimated cancer incidence, mortality and prevalence worldwide. World Health Organization. Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed July 2019.