Phase III ALUR study supports the use of Roche’s Alecensa for people with advanced ALK-positive lung cancer

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the phase III ALUR study met its primary endpoint, demonstrating that Alecensa® (alectinib) significantly improved progression-free survival (PFS) in people with anaplastic lymphoma kinase (ALK)-positive advanced (metastatic) non-small cell lung cancer (NSCLC) who had progressed following treatment with one prior line of both platinum-based chemotherapy and crizotinib, compared with chemotherapy. (1) The peer-reviewed data will be published later this year.

"We are pleased to announce that the results of the phase III ALUR trial further support the use of Alecensa as a treatment for people with ALK-positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster."

Alecensa received conditional marketing authorisation from the European Commission in people with ALK-positive NSCLC previously treated with crizotinib on 16 February 2017,(2) based on the results of the phase I/II NP28673 (3) and NP28761 (4) studies. Alecensa is also approved as a monotherapy (alone) for people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the US and nine other countries globally.(5) In addition, Alecensa is approved in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).(6)

Alecensa is also being explored as a first-line treatment option with the phase III ALEX study comparing Alecensa to crizotinib in ALK-positive NSCLC.(7) The ALEX study is expected to report data in the first half of 2017.

Approximately 75,000 people globally are diagnosed with ALK-positive NSCLC every year.(8,9,10) It is a distinct form of lung cancer commonly diagnosed in younger people (median age 52),11 and in women (approximately 54% of cases).(12) ALK-positive NSCLC is also generally found in those with a light or non-smoking history.(13)

About the ALUR study(1)
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 people with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib. People 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), central nervous system (CNS) objective response rate (ORR) in people with measurable brain metastases at baseline and median time to CNS progression. The multicentre study was conducted in 119 people across 15 countries.

About the NP28673 and NP28761 studies
NP28673 is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.(3) NP28761 is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib.(4) A pooled analysis from the NP28673 and NP28761 studies showed that Alecensa shrank tumours in 52.2% (95% CI: 39.7%, 64.6%) of people with advanced ALK-positive NSCLC whose disease had progressed following treatment with crizotinib (overall response rate; ORR).(3,4) The NP28673 study also showed that Alecensa extended the time that people lived without their disease worsening or death (PFS) by a median of 8.9 months(3) (95% CI: 5.6, 12.8), while the NP28761 study demonstrated a median PFS benefit of 8.2 months(14) (95% CI: 6.3, 12.6) with Alecensa.

In addition, a pooled analysis of the two studies showed that Alecensa shrank CNS tumours that were measurable in 64% of people (95% CI: 49.2%, 77.1%), and 22% (n=-29) achieved a complete response of their measurable and non-measurable CNS tumours.(15)

About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is an 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.(13) It is almost always found in people with a specific type of NSCLC called adenocarcinoma.(13) Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia 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 whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).(5,6)

In a pooled analysis of CNS endpoints from studies NP28673 and NP28761, Alecensa demonstrated activity in brain metastases, indicating that the drug may be taken up in the brain.(14) The brain is protected by the blood-brain barrier, a network of tightly joined cells that line the inside of the blood vessels in the brain and spinal cord.(16) One of the ways the blood-brain barrier prevents molecules from affecting the brain is to actively eject them from the barrier through a process known as 'active efflux'.(17) The active efflux system does not recognise Alecensa, which means that it may travel into and throughout brain tissue.(3,4)

The global phase III ALEX study of Alecensa includes a companion test developed by Roche Diagnostics. 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, 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 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.

1. ClinicalTrials.gov. [Internet; cited 2017 Mar 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02604342.
2. European Medicines Agency. [Internet; cited 2017 Mar 28]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004164/smops/Positive/human_smop_001082.jsp&mid=WC0b01ac058001d127.
3. 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. Ann Onc. 2016;27(sup 6):1263P.
4. Camidge R, et al. Updated efficacy and safety data from the phase 2 NP28761 study of alectinib in ALK-Positive Non-Small-Cell Lung Cancer. J Thorac Onc. 2016;12(15):S378.
5. F. Hoffmann-La Roche Ltd. data on file.
6. F. Hoffmann-La Roche Ltd. data on file.
7. ClinicalTrials.gov. [Internet; cited 2017 Mar 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02075840.
8. GLOBOCAN. Lung Cancer. [Internet; cited 2017 Mar 28]. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx.
9. American Cancer Society. What Is Non-Small Cell Lung Cancer? [Internet; cited 2017 Mar 28]. Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
10. Dearden S, et al. Mutation incidence and coincidence in non-small-cell lung cancer: meta-analyses by ethnicity and histology (mutMap). Ann Onc. 2013;24:2371-2376. 11. Shaw A, et al. Clinical features and outcome of patients with Non–Small-Cell Lung Cancer who harbor EML4-ALK. J Clin Oncol. 2009; 27(26): 4247-4253.
12. Takeuchi K, et al. Prospective and clinical validation of ALK immunohistochemistry: results from the phase I/II study of alectinib for ALK-positive lung cancer (AF-001JP study). Ann Onc. 2016;27:185-192.
13. Gridelli C, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treatment Reviews. 2014;40:300-306.
14. Camidge R, et al. Updated efficacy and safety data from the phase 2 NP28761 study of alectinib in ALK-positive non-small-cell lung cancer.oral presentation.WCLC.2016
15. Gadgeel S, et al. Pooled analysis of CNS response to alectinib in two studies of pre-treated ALK+ NSCLC. J Thorac Onc. 2015;10(9):S238 (suppl; 2).
16. Abbott J, et al. Astrocyte–endothelial interactions at the blood–brain barrier. Nature Reviews Neuroscience 2006;7:41-53.
17. Weickhardt A, et al. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene addicted non-small cell lung cancer. J Thorac Onc. 2012;1807-1814.

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