European Commission approves Roche’s Alecensa as the first and only
targeted adjuvant treatment for people with ALK-positive
early-stage lung cancer
European Commission approves Roche’s Alecensa as the
first and only targeted adjuvant treatment for people with
ALK-positive early-stage lung cancer
- Alecensa reduced the risk
of disease recurrence or death by an unprecedented 76% in people
with ALK-positive resected non-small cell lung cancer, as
demonstrated in the Phase III ALINA
study1
- Alecensa’s approval
addresses an urgent unmet need in the early-stage setting where
about half of all people experience disease recurrence following
surgery, despite adjuvant
chemotherapy2
- Early diagnosis and
treatment of lung cancer can reduce the burden associated with
progressive disease and give people the best possible chance of
cure3-6
Basel, 10 June 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Commission has approved Alecensa®
(alectinib) monotherapy, as adjuvant treatment following tumour
resection for adult patients with anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC) at high risk of
recurrence (Stage IB [≥4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).
Data from the Phase III ALINA trial, where Alecensa demonstrated an
unprecedented 76% reduction in the risk of disease recurrence or
death in people with resected ALK-positive NSCLC, supported the
marketing authorisation application.1
“For the first time, people in Europe who have undergone
surgical resection of ALK-positive NSCLC can be treated with an ALK
inhibitor, which can significantly reduce the risk of disease
recurrence or death,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development. “This
is a landmark approval for people who have historically faced a
high risk of their cancer returning after surgery. We are now able
to bring the transformational benefits of Alecensa to even more
people with ALK-positive lung cancer.”
“When it comes to early stage ALK-positive NSCLC, surgery is not
always enough as there remains a high risk of recurrence that
leaves patients concerned about what’s to come,” said Professor
Fabrice Barlesi, thoracic oncologist, Paris Saclay University and
chief executive officer of Gustave Roussy Institute. “The magnitude
of disease-free survival benefit observed in the ALINA study was
unprecedented and consistent across all disease stages. The use of
early ALK testing will help to identify all patients that could
benefit from this important new treatment option.”
In the ALINA study, Alecensa reduced the risk of disease
recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI:
0.13-0.43, p<0.0001) compared with platinum-based chemotherapy
in people with completely resected IB (tumour ≥ 4 cm) to IIIA
(UICC/AJCC 7th edition) ALK-positive NSCLC.1 In an
exploratory analysis, an improvement of central nervous system
disease-free survival was observed (HR=0.22; 95% CI:
0.08-0.58).1 This is of particular importance for people
with ALK-positive NSCLC, who are at greater risk of developing
brain metastases than those with other types of NSCLC.7
The safety and tolerability of Alecensa in the ALINA trial were
generally consistent with previous trials in the metastatic setting
and no unexpected safety findings were observed.1 These
data were published in the New England Journal of Medicine
in April 2024.
Alecensa is the preferred treatment option for patients with
advanced ALK-positive NSCLC and has transformed outcomes for people
with this disease. Approved in more than 100 countries as a first-
and second-line treatment, more than 94,000 patients with advanced
disease have been treated with Alecensa in clinical practice.
Following its approval in the adjuvant treatment setting, Alecensa
could for the first time play a pivotal role in ALK-positive
resectable disease, where there is a significant unmet medical
need. Today’s approval in Europe follows the April 2024 U.S. Food
and Drug Administration (FDA) approval of Alecensa as adjuvant
treatment following tumour resection for patients with ALK-positive
NSCLC (tumours ≥ 4 cm or node positive), as detected by an
FDA-approved test. Submissions to additional health authorities
worldwide are ongoing to bring this much-needed new treatment
option to as many patients as possible.
To support clinicians’ decision-making, routine testing of
resected surgical tissue or biopsy for ALK, EGFR and PD-L1
biomarkers in patients with stage IB to IIIA and select IIIB
(UICC/AJCC 8th edition) NSCLC, in addition to in the advanced
setting, is recommended by international guidelines, including the
National Comprehensive Cancer Network® Clinical Practice Guidelines
in Oncology (NCCN Guidelines®).
About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomised,
active-controlled, multicentre, open-label study evaluating the
efficacy and safety of adjuvant Alecensa® (alectinib) compared with
platinum-based chemotherapy in people with resected Stage IB
(tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition)
anaplastic lymphoma kinase (ALK)-positive non-small cell lung
cancer. The study included 257 patients who were randomly assigned
to either the Alecensa or chemotherapy treatment arm. The primary
endpoint is disease-free survival. Secondary outcome measures
include overall survival and percentage of patients with adverse
events.
About lung cancer
Lung cancer is one of the leading causes of cancer death
globally.8 Each year 1.8 million people die as a result
of the disease; this translates into more than 4,900 deaths
worldwide every day.8 Lung cancer can be broadly divided
into two major types: non-small cell lung cancer (NSCLC) and
small-cell lung cancer. NSCLC is the most prevalent type,
accounting for around 85% of all cases.9 Today, about
half of all people with early lung cancer (45-76%, depending on
disease stage) still experience a cancer recurrence following
surgery, despite adjuvant chemotherapy.2 Treating lung
cancer early, before it has spread, may help prevent the disease
from returning and provide people with the best opportunity for a
cure.10
About Alecensa® (alectinib)
Alecensa is a highly selective, central nervous system-active, oral
medicine created at Chugai, a member of the Roche Group, Kamakura
Research Laboratories for people with non-small cell lung cancer
(NSCLC) whose tumours are identified as anaplastic lymphoma kinase
(ALK)-positive. Alecensa is already approved in over 100 countries
as an initial (first-line) and second-line treatment for
ALK-positive, metastatic NSCLC, including in the United States,
Europe, Japan and China. Alecensa was approved by the U.S. Food and
Drug Administration (FDA) in April 2024 as adjuvant treatment
following tumour resection for patients with ALK-positive NSCLC
(tumours ≥ 4 cm or node positive), as detected by an FDA-approved
test, and in June 2024 by the European Commission, as a monotherapy
for adjuvant treatment following tumour resection for adult
patients with ALK-positive NSCLC at high risk of recurrence (Stage
IB [≥4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).
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 six 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. Roche is
committed to improving treatment of early-stage lung cancers to
help increase the chance of cure for more people.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Solomon B, et al. ALINA: efficacy and safety of adjuvant
alectinib versus chemotherapy in patients with early-stage ALK+
non-small cell lung cancer (NSCLC). Presentation at: European
Society for Medical oncology Congress; 2023 October 20-24.
Late-breaking abstract #LBA2.
[2] Pignon JP, et al. Lung adjuvant cisplatin evaluation: a pooled
analysis by the LACE collaborative group. J Clin Oncol.
2008;20;26(21):3552-9.
[3] Polanski J, et al. Quality of life of patients with lung
cancer. Onco Targets Ther. 2016;29(9):1023–1028.
[4] Yang CY, et al. Stage shift improves lung cancer survival:
real-world evidence. J Clin Oncol 2023;18(1):47-56.
[5] Nugent SM, et al. Longitudinal health-related quality of life
among individuals considering treatment for Stage I non–small-cell
lung cancer. Ann Am Thorac Soc. 2020;17(8):988-997.
[6] Sharma R, et al. Estimating recurrences prevented and costs
avoided with atezolizumab in early non-small cell lung cancer in
the United States. Cancer Med. 2022;12(6):7450–7458.
[7] Griesinger F, et al. Brain metastases in ALK-positive NSCLC –
time to adjust current treatment algorithms. Oncotarget.
2018;9(80):35181-35194.
[8] Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol.
2021;21(1):45-52.
[9] American Cancer Society: What Is Lung Cancer? [Internet; cited
2024 May] Available from:
https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
[10] 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.
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