ALECENSARO (alectinib) approved by Health Canada for first-line treatment of ALK-positive lung cancer

Targeted oral treatment shown to reduce risk of death or disease progression by more than half compared to standard of care, while also reducing the risk of tumours spreading to and growing in the Central Nervous System (CNS)1

MISSISSAUGA, ON, June 13, 2018 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved ALECENSARO as a monotherapy for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1

The approval is based on results from the Phase III ALEX study showing ALECENSARO reduced the risk of disease progression or death by more than half (53%) versus crizotinib, the current standard of care.2 Study data also showed that, compared to crizotinib, ALECENSARO reduced the risk of tumours spreading to, or growing in, the brain or CNS by 84%.1

"For those diagnosed with ALK-positive NSCLC, the new approval for use of alectinib (ALECENSARO) offers a first-line treatment that is well tolerated and has shown superior efficacy over the current standard of care," says Dr. Randeep Sangha, medical oncologist at Cross Cancer Institute. "This treatment also meets a significant unmet need by reducing the risk of CNS progression, which is important for patients as the growth or spread of tumours in the CNS is often associated with a poor prognosis."2, 3

ALK-positive NSCLC is often found in younger adults (50 years or younger) who either have no history of smoking or are former light smokers.4 This distinct form of lung cancer occurs in approximately 4-5% of all NSCLC cases.5

"Lung cancer that has spread to the brain has a significant effect on both prognosis and quality of life," says Shem Singh, Executive Director at Lung Cancer Canada. "Current treatments for brain metastases, such as whole brain radiation, have the potential to leave a patient with permanent cognitive impairments. Oral treatments that both decrease the risk of tumours spreading to the brain and work on tumours that have already spread there means that patients can spend less time in the hospital, have fewer serious side effects and spend more quality time with family and friends."

Approximately 15-35% of ALK-positive NSCLC patients have brain metastases at the time of their initial diagnosis,6,7 and the median survival of individuals with NSCLC after the diagnosis of brain metastases is 1-3 months if left untreated.3 As the blood-brain barrier often makes it difficult for anti-cancer drugs to treat brain and CNS metastases,8 ALECENSARO's ability to penetrate the blood-brain barrier makes it an effective treatment in delaying the development and worsening of tumours in the CNS.2

"My diagnosis with ALK-positive lung cancer - and learning the advanced stage of my disease - left me completely shattered and overwhelmed. Managing the impact of my disease has been life-altering for me and my family," says Delores Zuk, who learned about her ALK-positive lung cancer diagnosis in 2015. "Knowing that there is a medication targeted to my specific disease helps me face each day with a more positive attitude, with the hope that there are more days ahead of me."

About the ALEX Study
The ALECENSARO first-line approval is based on results from the randomized, multicentre, open-label Phase III ALEX study. ALEX evaluated the efficacy and safety of ALECENSARO versus crizotinib in 303 treatment-naïve people with ALK-positive NSCLC across 98 sites.2 Patients were randomized (1:1) to receive either ALECENSARO or crizotinib.2

The primary endpoint of the ALEX study was progression-free survival (PFS) as assessed by the investigator, and secondary endpoints included: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (as defined by Response Evaluation Criteria in Solid Tumours criteria), duration of response, overall survival, health-related quality of life and safety.2

Results from the study showed that ALECENSAO significantly reduced the risk of disease worsening or death (PFS) by 53% (hazard ratio (HR)=0.47, 95% confidence interval (CI): 0.34-0.65, p<0.0001) compared to crizotinib. The study also showed that ALECENSARO reduced the risk of tumours spreading to, or growing in, the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.0001).1

The safety profile of ALECENSARO was consistent with that observed in previous studies and compared favourably to crizotinib.2 The most common adverse events in patients in the ALECENSARO arm (≥10% absolute difference) were constipation (34%), myalgia (23%), fatigue (26%), edema (22%), increased bilirubin (21%), anemia (20%), rash (15%), alanine aminotransferase increased (15%), aspartate aminotransferase increased (14%), nausea (14%), diarrhea (12%), and bradycardia (11%). Adverse events leading to discontinuation (11%), dose reduction (16%) and dose interruption (19%) were all lower in the ALECENSARO arm compared with the crizotinib arm. Serious adverse reactions occurred in 28% of patients treated with ALECENSARO, and grade 3 or higher adverse events occurred in 41%.1

About ALECENSARO
ALECENSARO is a prescription, twice-daily oral medicine that blocks the activity of the ALK protein, which may slow down the growth and spread of NSCLC.1 ALECENSARO is also indicated in Canada under the Notice of Compliance with Conditions (NOC/c) policy for use as a monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.1

ALECENSARO was developed by Chugai Pharmaceuticals (a member of the Roche group of companies) to target and treat ALK-positive tumours, representing the next advancement in Roche's long-standing commitment to developing and delivering targeted, personalized medicines to patients.

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 devastating 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
Headquartered in Basel, Switzerland, 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.

Roche Canada was founded in 1931. The company employs over 1,000 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com

All trade-marks mentioned are the property of their respective owners.

© Copyright 2018, Hoffmann-La Roche Limited

REFERENCES
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1

ALECENSARO (alectinib) Product Monograph. Hoffmann-La Roche Limited. June 11, 2018.

2

Peters, S. et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. New England Journal of Medicine, 2017, 377:829-838. http://www.nejm.org/doi/full/10.1056/NEJMoa1704795.

3

Ali A, Goffin JR, Arnold A, Ellis PM. Survival of patients with non-small-cell lung cancer after a diagnosis of brain metastases. Curr Oncol. 2013;20(4):e300-306.

4

Gridelli, et al. ALK inhibitors in the treatment of advanced NSCLC. Cancer Treat Rev 2014;40(2): 300-306. 

5

Chia, P.L. et al. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clinical Epidemiology, 2014, 6: 423-432. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4242069/pdf/clep-6-423.pdf.

6

Shi W, Dicker AP. CNS Metastases in Patients With Non-Small-Cell Lung Cancer and ALK Gene Rearrangement. J Clin Oncol. 2016;34(2):107-109.

7

Guerin A, Sasane M, Zhang J, et al. Brain metastases in patients with ALK+ non-small cell lung cancer: clinical symptoms, treatment patterns and economic burden. J Med Econ. 2015;18(4):312-322.

8

Canadian Cancer Society. Brain metastases. http://www.cancer.ca/en/cancer-information/cancer-type/metastatic-cancer/brain-metastases/?region=on.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

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