- 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