Health Canada authorizes Alecensaro® (alectinib) as the first and only adjuvant treatment for people with ALK-positive early-stage lung cancer

• Alecensaro reduced the risk of disease recurrence or death by 76% in people with ALK-positive resected non-small cell lung cancer, as demonstrated in the Phase III ALINA study¹
• The approval addresses an urgent unmet need in the early-stage setting where about half of all people experience disease recurrence following surgery²

MISSISSAUGA, ON, July 16, 2024 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on June 27, 2024, Health Canada granted approval of Alecensaro^® (alectinib) monotherapy as adjuvant treatment following tumour resection for patients with stage IB (tumours ≥ 4 cm) to IIIA* anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).² With a 76% reduction in the risk of recurrent disease or death compared to chemotherapy alone, Alecensaro is the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour.

Data from the Phase III ALINA trial supported the Health Canada application and approval, which obtained Priority Review status by Health Canada. Priority review status applies to a New Drug Submission (NDS) or Supplemental New Drug Submission (S/NDS) for a serious, life-threatening or severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness that the drug provides:

• effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
• a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.

"Surgery alone has not been enough to manage early-stage ALK-positive NSCLC, and the high risk of recurrence for patients has been a serious concern," said Dr. Stephanie Snow, Medical Oncologist, QEII Health Sciences Center, Professor of Medicine at Dalhousie University, and President, Lung Cancer Canada. "The magnitude of disease-free survival benefit observed in the ALINA study was unprecedented and consistent across all disease stages. Now, early ALK testing and treatment with Alecensaro gives patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread."

Given that early data signals were positive, the Health Canada application was also conducted under the Project Orbis initiative, a framework for the concurrent submission and review of oncology medicines among international partners. Health Canada collaborated with the Australian Therapeutics Goods Administration (TGA), Singapore's Health Sciences Authority, Brazil's National Health Surveillance Agency (ANVISA), the US Food & Drug Administration (FDA), Israel's Ministry of Health (IMoH) Pharmaceutical Administration, Switzerland's Swissmedic, and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (UK MHRA). The intent is that collaboration among international regulators may ultimately allow patients with cancer to receive earlier access to safe, effective and needed treatments.

Now that Health Canada authorization has been secured, Roche Canada looks forward to working with Canada's health technology assessment agencies - Canada's Drug Agency (CDA) and l'Institut national d'excellence en santé et en services sociaux (INESSS) - the pan-Canadian Pharmaceutical Alliance (pCPA), as well as provincial and territorial governments, to quickly secure sustainable, equitable access for patients to Alecensaro.

Lung cancer is one of the leading causes of cancer death globally³ and, here in Canada, about 1 in 15 women will develop lung cancer in their lifetime and 1 in 14 men will develop the disease⁴. Non-small cell lung cancer is the most common type of lung cancer.⁵

Patients with ALK+ NSCLC are typically younger, often economically active with dependents, and frequently never smokers.^6-9 This cancer has high recurrence rates and a significant risk of brain metastases,^10,11 necessitating early and aggressive treatment to prevent disease recurrence and provide the best opportunity for a cure.¹²

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicentre, open-label study evaluating the efficacy and safety of adjuvant Alecensaro (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. The study included 257 patients who were randomly assigned to either the Alecensaro or chemotherapy treatment arm. The primary endpoint is disease-free survival (DFS). Secondary outcome measures include overall survival, central nervous system-DFS, and percentage of patients with adverse events.

About Alecensaro^® (alectinib)
Alectinib is a highly selective and potent ALK (anaplastic lymphoma kinase) and RET (Rearranged during Transfection) tyrosine kinase inhibitor. Alecensaro belongs to a group of anti-tumour medicines which stop cancer from making new cells if the cancer is caused by a defect in the ALK gene. By doing so, Alecensaro may slow down the growth and spread of non-small cell lung cancer (NSCLC).

Alecensaro is an oral medicine created at Chugai, a member of the Roche Group, Kamakura Research Laboratories for people with NSCLC whose tumours are identified as ALK-positive. Alecensaro is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in Canada, the United States, Europe, Japan and China.

About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

With our combined strength in diagnostics and pharmaceuticals, we're driving personalized healthcare (PHC) forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone.

And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn, or on X @RocheCanada.

References

*According American Joint Committee on Cancer [7th edition]

^[1]	Wu Y-L et al. Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer. NEJM. 2024;390:1265-1276.
^[2]	ALECENSARO Product Monograph, June 27, 2024.
^[3]	Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52.
^[4]	Lung Cancer Statistics." www.cancer.ca, Canadian Cancer Society https://cancer.ca/en/cancer-information/cancer-types/lung/statistics
^[5]	American Cancer Society: What Is Lung Cancer? [Internet; cited 2024 April] Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
^[6]	Shaw AT, Yeap BY, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247-4253.
^[7]	Chia PL, Mitchell P, Dobrovic A, John T. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clin Epidemiol 2014;6:423-432.
^[8]	Howlader N NA, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA. SEER Cancer Statistics Review, 1975-2016. Bethesda, MD: National Cancer Institute, 2019.
^[9]	Mori M, Hayashi H, Fukuda M, et al. Clinical and computed tomography characteristics of non-small cell lung cancer with ALK gene rearrangement: Comparison with EGFR mutation and ALK/EGFR-negative lung cancer. Thorac Cancer 2019;10:872-879.
^[10]	Johung KL, Yeh N, Desai NB, et al. Extended Survival and Prognostic Factors for Patients With ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastasis. J Clin Oncol 2016;34:123-129.
^[11]	Shi W, Dicker AP. CNS Metastases in Patients With Non-Small-Cell Lung Cancer and ALK Gene Rearrangement.  J Clin Oncol 2016;34(2):107-9.
^[12]	Hendricks LE, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4): 339-357.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

For questions, please contact: Laura Pagnotta, Strategic Communications, Roche Canada, [email protected], 289-808-3404