Health Canada approves ALECENSARO™ - a targeted oral treatment - for patients with aggressive and rare form of lung cancer

Early data suggests ALECENSARO also shows strong efficacy in treating the spread of lung cancer to the brain, a critical unmet need for patients

MISSISSAUGA, ON, Oct. 31, 2016 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved ALECENSARO™ (alectinib) 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  

Health Canada has approved ALECENSARO under provisions made in its Notice of Compliance with Conditions (NOC/c) policy. This policy facilitates earlier access to promising new medicines that treat, prevent or diagnose serious, life-threatening and/or severely debilitating diseases for which there is no alternative medicine available in Canada, or where the new medicine offers a significant improvement through its risk/benefit profile over existing medicines.2

Today, lung cancer kills more Canadians annually than breast, prostate and colorectal cancers combined.3 And while many forms of lung cancer express genetic mutations (or rearrangements), making them harder to treat, ALK-positive disease – which impacts approximately four to five per cent of NSCLC patients4 – is especially complicated. 

Patients with ALK-positive, NSCLC are typically younger in age and either have no history of smoking or are former light smokers.5 A common place for this type of cancer to spread during initial targeted treatment is the central nervous system (CNS), including the brain.6,7 Approximately 26 per cent of ALK-positive NSCLC patients have brain metastases at the time of their initial diagnosis,8 and up to 60 per cent of patients have brain metastases when their disease worsens or spreads. The majority of individuals with lung cancer do not survive longer than three months after the diagnosis of brain metastasis.9

"ALK-positive NSCLC can be a deadly form of cancer that commonly spreads to the CNS during initial treatment," says Dr. Parneet Cheema, medical oncologist at the Sunnybrook Odette Cancer Centre. "The approval of ALECENSARO offers physicians an innovative oral treatment option for ALK-positive NSCLC patients, that is well tolerated and demonstrates efficacy on lung cancer tumours found in the lungs, brain and other areas of the CNS."

Almost all ALK-positive NSCLC patients experience their disease worsening despite initial treatment, with approximately 46 per cent developing CNS metastases as their first site of progression.6 Approximately 60 per cent of patients who participated in the two pivotal, Phase II studies of ALECENSARO presented with cancer that had already spread to the brain or other parts of the CNS.1

"While a lung cancer diagnosis is devastating news for patients and their families, the added complication of brain metastases has the potential to even further limit their quality of life," says Shem Singh, Executive Director of Lung Cancer Canada. "Having new, effective treatment options for lung cancer patients is important so that they can be given a chance to fulfil life goals and spend precious time with friends and family."

"Brain tumours affect nearly every aspect of a patient's life, and can negatively impact an individual's vision, hearing, mobility, balance and memory, as well as having a profound impact on their loved ones," says Susan Marshall, Chief Executive Officer of Brain Tumour Foundation of Canada. "Given how common it is for certain types of lung cancer to metastasize in the brain and central nervous system, and the challenges associated with delivering effective therapies across the blood-brain barrier, the introduction and availability of new medicines that address this unmet need are vital."

About the Health Canada Approval 1

The Health Canada approval of ALECENSARO is based on two pivotal, Phase I/II studies (NP28673 and NP28761), in which the treatment shrank tumours in up to 50 per cent of people with ALK-positive NSCLC whose disease had worsened on crizotinib – the current standard of care in the "first line" (initial treatment) setting. ALECENSARO shrank tumours in nearly 48 per cent of people in the NP28761 trial (Objective Response Rate [ORR] of 47.8 per cent [95 per cent CI 35.6-60.2]) and in 50 per cent people in the NP28673 trial (ORR of 50 per cent [95 per cent CI 40.8-59.1]). In the subset of patients who presented with cancer that had spread to the brain or other parts of the CNS, ALECENSARO shrank CNS tumours in about 60 per cent of patients (CNS ORR of 61 per cent [95 per cent CI 46.1-74.2]).

The most common adverse reactions (≥10 per cent) were fatigue (41 per cent), constipation (34 per cent), swelling caused by fluid build-up in the body (30 per cent), musculoskeletal pain (29 per cent), nausea (18 per cent), headache (17 per cent), diarrhea (16 per cent), increased aspartate aminotransferase (16 per cent), increased bilirubin (15 per cent), anemia (14 per cent), alanine aminotransferase increased (14 per cent), rash (18 per cent), vomiting (12 per cent), increased blood creatine phosphokinase (12 per cent), weight gain (11 per cent), vision problems (10 per cent), joint pain (10 per cent), dizziness (10 per cent) and sensitivity to sunlight (10 per cent).

Serious adverse reactions were reported in 19 per cent of the patients and the most frequently reported serious adverse reactions were pulmonary embolisms, shortness of breath (dyspnea) and hyperbilirubinemia (1.2 per cent each). Fatal adverse reactions in patients treated with ALECENSARO occurred in 2.8 per cent of patients, consisting of hemorrhage (2 patients, 0.8 per cent), tears in the intestine, shortness of breath, swelling of the lungs, endocarditis and death (unspecified) (1 patient each, 0.4 per cent).

About the NP28761 and NP28673 Studies 1

NP28761 is a Phase I/II North American, single-arm, open-label, multicentre trial evaluating the safety and efficacy of ALECENSARO (600 mg orally twice daily) in people with ALK-positive NSCLC whose disease worsened on crizotinib. There were 87 participants in the Phase II study.

NP28673 is a Phase I/II global, single-arm, open-label, multicentre trial evaluating the safety and efficacy of ALECENSARO (600 mg orally twice daily) in people with ALK-positive NSCLC whose disease worsened on crizotinib. There were 138 participants in the Phase II study.

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 CNS (CNS ORR and CNS DOR).

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 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.

In addition to Canada, ALECENSARO has received accelerated approval from the U.S. Food and Drug Administration (FDA), who granted it a Breakthrough Therapy Designation in 2013, and orphan drug status in 2015.10 The medicine, which is marketed under the trade name ALECENSA® outside of Canada, is also approved for use in Israel and Japan.11

About Lung Cancer

According to the Canadian Cancer Society, lung cancer is the most commonly diagnosed cancer in Canada (excluding non-melanoma skin cancers), and is the leading cause of cancer-related death for both men and women in the country.12 It is estimated that 26,600 Canadians are diagnosed with lung cancer annually, representing 14 per cent of all new cancer cases in the country.12 Approximately 85-90 per cent of all lung cancer cases are diagnosed as NSCLC,13 and with the majority of lung cancer cases diagnosed at advanced stages, can be very difficult to treat.14

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1886, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. 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.

Roche Canada was founded in 1931. The company employs approximately 900 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, please visit www.rochecanada.com.

All trademarks used or mentioned are legally protected.

REFERENCES
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1

Alecensaro (alectinib) Product Monograph; September 30, 2016.

2

Health Canada. Guidance Document: Notice of Compliance with Conditions (NOC/c). Available online at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/noccfs_accfd-eng.php. Last accessed on June 1, 2016.

3

Canadian Cancer Society. Canadian Cancer Statistics 2015. Available on page 6 at: http://www.cancer.ca/~/media/cancer.ca/CW/publications/Canadian%20Cancer%20Statistics/Canadian-Cancer-Statistics-2015-EN.pdf. Last accessed on June 27, 2016.

4

Chia 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.

5

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

6

Weickhardt, 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 Oncol. 2012 December ; 7(12): 1807–1814. Available online at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3506112/pdf/nihms415046.pdf. Last accessed on June 1, 2016.

7

Shi W and Dicker A. Journal of Clinical Oncology. CNS Metastases in Patients With Non–Small-Cell Lung Cancer and ALK Gene Rearrangement. Available online at: http://jco.ascopubs.org/content/early/2015/11/30/JCO.2015.63.9682.full.pdf+html. Last accessed on June 1, 2016.

8

Solomon, et al. First-Line Crizotinib versus Chemotherapy in ALK-Positive Lung Cancer. N Engl J Med 2014;371:2167-77. Available online at: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1408440. Last accessed on June 1, 2016.

9

Ray et al. Comparative analysis of survival, treatment, cost and resource use among patients newly diagnosed with brain metastasis by initial primary cancer. Journal of Neuro-Oncology. 2013 May. Available online at:  https://www.researchgate.net/publication/236934231_Comparative_analysis_of_survival_treatment_cost_and_resource_use_among_patients_newly_diagnosed_with_brain_metastasis_by_initial_primary_cancer Last accessed on August 25, 2016.

10

Genentech Press Release. FDA Grants Genentech's Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer. Available online at: http://www.gene.com/media/press-releases/14615/2015-12-11/fda-grants-genentechs-alecensa-alectinib. Last accessed on June 1, 2016.

11

Roche Press Release. Japan becomes first country to approve Roche's alectinib for people with a specific form of advanced lung cancer. Available online at: http://www.roche.com/media/store/releases/med-cor-2014-07-04.htm. Last accessed on June 1, 2016.

12

Canadian Cancer Society. Lung Cancer. Available online at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on. Last accessed on August 2, 2016.

13

Canadian Cancer Survivor Network. What is lung cancer? Available online at: http://survivornet.ca/en/cancer_basics/lung_cancer_portal/what_is_lung_cancer. Last accessed on August 2, 2016.

14

Canadian Cancer Society. Survival statistics for non–small cell lung cancer. Available online at:      http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/survival-statistics/?region=on. Last accessed on August 15, 2016.

 

SOURCE Roche Canada

For further information: Kate Hanna, Roche Canada, T: 905-285-7729, E: kate.hanna@roche.com; Beth Daniher, Agnostic, T: 416-969-2664, E: bdaniher@thinkagnostic.com


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