Media Release

Basel, 03 April 2018

Roche’s Alecensa (alectinib) approved as a first-line treatment for people with a specific type of lung cancer in Switzerland

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Swiss authority for the licensing and monitoring of therapeutic products (Swissmedic) has granted approval for Alecensa® (alectinib) as a first-line treatment for patients with advanced or metastatic ALK (anaplastic lymphoma kinase)-positive, non-small cell lung cancer (NSCLC).1

The approval for first-line treatment is based on results from the global phase III ALEX study, which showed that Alecensa significantly reduced the risk of the disease worsening or death (progression-free survival, PFS) by 53% (HR=0.47, 95% CI: 0.34-0.65, p<0.001) compared to the existing standard, crizotinib. The study also showed that Alecensa reduced the risk of the disease spreading to, or growing in, the brain or central nervous system (CNS) by 84% compared with crizotinib (HR=0.16, 95% CI: 0.10-0.28, p<0.001). The safety and tolerability profile of Alecensa compared favourably to that of crizotinib despite the longer duration of treatment with Alecensa (17.9 vs. 10.7 months), and was consistent with that observed in previous studies.1,2

“I am delighted that Alecensa is now also available for first-line treatment in people with advanced ALK-positive lung cancer,” said Prof. Oliver Gautschi from the Cantonal Hospital Lucerne. “The medicine has the potential to fundamentally change our therapeutic approach to this condition.”

ALK-positive NSCLC is a type of lung cancer that occurs in about 5 % of people with advanced NSCLC. It is diagnosed in about 75,000 people worldwide and around 80 in Switzerland each year. Unlike other types of lung cancer, ALK-positive NSCLC often occurs in people who have a light or non-smoking history. It occurs more frequently in women than in men, and patients are considerably younger than those with other types of lung cancer, with a median age of 52.3,4,5

About the ALEX study

ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve people with ALK-positive non-small cell lung cancer (NSCLC) whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised 1:1 to receive either Alecensa or crizotinib. The primary endpoint of the ALEX study is progression-free survival (PFS) as assessed by the investigator, and secondary endpoints include: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (as defined by RECIST criteria), duration of response, overall survival, health-related quality of life and safety. The multicentre study was conducted in 303 people across 161 sites in 31 countries.2,6

About Alecensa

Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS-active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with non-small cell lung cancer (NSCLC) whose tumours are identified as ALK-positive. Alecensa has already been approved by the FDA in the United States, by the EMA in Europe, and in Japan, Australia and Turkey as a first-line treatment for people with ALK-positive NSCLC.

About Roche in lung cancer

Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

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. 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. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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.

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References

  1. Information for healthcare professionals about Alecensa® is available at www.swissmedicinfo.ch
  2. Peters, S et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer. NEJM 2017;377:829–838
  3. Gridelli C, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treatment Reviews. 2014;40:300-306
  4. GLOBOCAN 2012. Estimated cancer incidence, mortality and prevalence worldwide in 2012. Most recently accessed in March 20018 at http://globocan.iarc.fr/old/FactSheets/cancers/lung-new.asp
  5. European Cancer Observatory 2012. Estimated cancer incidence and mortality in European Union. Most recently accessed in March 20018 at http://eco.iarc.fr/eucan/Country.aspx?ISOCountryCd=756
  6. ClinicalTrials.gov. A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX) [Internet; cited 2017 Oct 03]. Available at: https://clinicaltrials.gov/ct2/show/NCT02075840