Roche presents data from global phase III study showing significant clinical benefit of Alecensa (alectinib) in later-line advanced ALK-positive lung cancer

• ALUR study shows 85% reduction in risk of disease worsening or death versus chemotherapy in patients with advanced ALK-positive NSCLC who had progressed on chemotherapy and crizotinib

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.¹

“The strikingly positive results from the ALUR study across multiple endpoints provide strong further evidence of the efficacy of Alecensa in this setting,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We believe this robust data will support access to Alecensa for patients with ALK-positive lung cancer.”

The ALUR data will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress on Monday 11 September 2017, at 09:30-10:30 CET (Abstract #1299O).

The phase III ALUR study also demonstrated:

• An overall response rate (ORR) of 36.1% for Alecensa versus 11.4% for chemotherapy (95% CI 0.05–0.43).
• Central nervous system (CNS) ORR in patients with measurable disease of 54.2% for Alecensa versus 0% for chemotherapy (95% CI 0.23–0.78).
• A disease control rate of 80.6% for Alecensa versus 28.6% for chemotherapy (95% CI 0.33–0.69)
• A median duration of response (DOR) of 9.3 months for Alecensa (95% CI 6.9–not estimable [NE]) versus 2.7 months with chemotherapy (95% CI NE).
• Adverse events (AEs; all grades) occurred in 77.1% Alecensa patients compared with 85.3% chemotherapy patients, with Grade 3–5 AEs in 27.1% and 41.2%, respectively. There was one fatal AE in the chemotherapy arm, with none in the Alecensa arm.
• AEs leading to discontinuation or dose reduction occurred in 10% patients in the Alecensa arm versus 20.6% in the chemotherapy arm.¹

Alecensa is approved as a monotherapy for patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan. Alecensa is also approved in Japan for patients whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). In the United States, Alecensa was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2015 for the treatment of patients with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib.²

About the ALUR study

ALUR (NCT02604342) is a randomised, multi-centre, open-label phase III study evaluating the efficacy and safety of Alecensa versus chemotherapy (pemetrexed or docetaxel) in patients with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib. Patients were randomised (2:1) to receive either Alecensa or chemotherapy. The primary endpoint of the ALUR study is PFS and secondary endpoints include: overall survival (OS), CNS ORR in patients with measurable brain metastases at baseline and median time to CNS progression. The multicentre study was conducted in 107 patients across 15 countries.³

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 NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma.⁴ Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Thailand and Taiwan for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in Japan for people with ALK-positive NSCLC.⁵

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 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.

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References

1. Novello, S et al. Primary results from the phase III ALUR study of alectinib versus chemotherapy in previously treated ALK+ non-small-cell lung cancer (NSCLC). Presented at: ESMO 2017 Congress; 2017 Sept 8-12. Abstract #1299O.
2. US Food & Drug Adminstration. FDA approves new oral therapy to treat ALK-positive lung cancer. [Internet; cited 2017 September]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm.
3. ClinicalTrials.gov. Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib [Internet; cited 2017 September]. Available from: https://clinicaltrials.gov/ct2/show/NCT02604342.
4. Gridelli C, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treatment Reviews. 2014;40:300-306.
5. F. Hoffmann-La Roche Ltd. data on file. September 2017.