Roche’s Alecensa (alectinib) approved in Switzerland for people with a specific type of lung cancer

Basel, 08 February 2017

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval to Alecensa® (alectinib) for the treatment of people with ALK (anaplastic lymphoma kinase)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.1

In the two pivotal studies, Alecensa shrank tumours in about half the people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR]: up to 52%). Median progression-free survival (PFS) in people who received alectinib was 8.2 and 8.9 months, respectively.1‑5

In a subset of people with tumours that had spread to the brain or other parts of the central nervous system (CNS), Alecensa reduced CNS tumours in about 64 percent (overall response rate CNS ORR) of people with measurable brain metastases and achieved a complete response (CR) in 27 percent of all affected people.6

“Alecensa is now approved as a treatment option for people with ALK-positive NSCLC. The new medicine has the potential to fundamentally change our therapeutic approach to this condition,” said Prof. Oliver Gautschi of Lucerne Cantonal Hospital.

ALK-positive NSCLC is a subtype of lung cancer that occurs in about 5 percent of people with advanced NSCLC. It is diagnosed in about 60,000 people worldwide and about 80 in Switzerland each year. Unlike other kinds of lung cancer, ALK-positive NSCLC occurs mainly in people who have a light or non-smoking history. It is more common in women than men, and those affected are considerably younger than in other types of lung cancer, with a median age of 52 years.7‑9

About the two pivotal studies

Study 1 (NP28761) is a phase II North American, single-arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa (600 mg orally twice daily) in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib.5

Study 2 (NP28673) is a phase II global, single-arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa (600 mg orally twice daily) in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.4

In both trials, the primary endpoint was ORR according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1), as evaluated by an Independent Review Committee (IRC). Secondary endpoints included duration of response (DOR) and efficacy against disease that had spread to the central nervous system (CNS).4,5

About Alecensa

Alecensa is an oral medicine created at Chugai Research Laboratories that has been developed for people with NSCLC whose tumours are identified as ALK-positive. Alecensa is a highly selective and potent inhibitor of ALK tyrosine kinase. Inhibition of ALK tyrosine kinase activity blocks intracellular signalling pathways and induces cell death in ALK-dependent tumour cells.

Previous studies and the two pivotal studies of Alecensa have demonstrated its activity against metastases in the CNS (brain metastases). Efflux transporters expressed at the blood-brain barrier, such as P‑glycoprotein (P‑gp), prevent certain drugs from reaching the brain by actively transporting them back to the blood. It has been shown that Alecensa is not transported back by P‑gp and is therefore able to reach the brain.1,10,11

Alecensa has a tolerable side effect profile. Most adverse events were mild to moderate (grade 1‑2), and no grade 5 events were observed. The frequencies of dose reduction due to adverse drug reactions in the two pivotal studies were low, at 9 and 16 percent, respectively. Possible side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include fatigue, constipation and swelling in the hands, feet, ankles and eyelids.1,4,5

Alecensa is also being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC, and has received Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA) for this indication.

The Global phase III studies of Alecensa include a companion test developed by Roche.12 Alecensa is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group.

About Roche in lung cancer

Lung cancer is a major area of focus and investment for Roche. 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 two 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 for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine 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 eight 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 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 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 in this release are protected by law.

References

1. Alecensa® product information at www.swissmedicinfo.ch.

2. Barlesi F et al., Updated efficacy and safety from the global phase II NP28673 study of alectinib in patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC), ESMO 2016, Annals of Oncology 27 (Supplement 6): vi416-vi454, 2016.

3. Bordogna W et al., Updated Efficacy and Safety Data from the Phase 2 NP28761 Study of Alectinib in ALK-Positive Non-Small-Cell Lung Cancer, WCLC 2016 Abstract and oral presentation MA07.02.

4. Ou SI et al., Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study. J Clin Oncol 2016; 34: 661-668.

5. Shaw AT et al., Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol 2016; 17: 234-42.

6. Gadgeel M et al., Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer, Journal of Clinical Oncology 2016; 34: 4079-4085.

7. Very Well. ALK Positive Lung Cancer Definition and Treatment. Last accessed in December 2016 at https://www.verywell.com/what-is-alk-positive-lung-cancer-2248944.

8. European Cancer Observatory 2012. Estimated cancer incidence and mortality in European Union. Last accessed in December 2016 at http://eco.iarc.fr/eucan/Country.aspx?ISOCountryCd=930.

9. GLOBOCAN 2012. Estimated cancer incidence, mortality and prevalence worldwide in 2012. Last accessed in December 2016 at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.

10. Gadgeel M et al., Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol 2014; 15: 1119-28.

11. Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74(5):1023-1028.

12. https://clinicaltrials.gov/ct2/show/NCT02075840: ALEX Study: A Randomized, Phase III Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants.