Roche’s Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer
18 10월 2023 - 2:00PM
Roche’s Alecensa reduces the risk of disease recurrence or death by
an unprecedented 76% in people with ALK-positive early-stage
non-small cell lung cancer
- These Phase III data are
the first and only to show an improvement in disease-free survival
in early-stage resected ALK-positive non-small cell lung cancer
(NSCLC)
- With about one in two
people with early-stage NSCLC experiencing disease recurrence
following surgery, despite adjuvant
chemotherapy,1 more effective
treatment options are urgently needed to provide the best chance
for cure2
- Data are being presented as
a late-breaking oral during the ESMO 2023 Presidential
Symposium
Basel, 18 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today results from the primary analysis of the Phase III
ALINA study demonstrating a statistically significant and
clinically meaningful improvement in disease-free survival (DFS;
primary endpoint). The study results showed that Alecensa®
(alectinib) reduces 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
stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic
lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).3
A clinically meaningful improvement of central nervous system
(CNS)-DFS was also observed (HR=0.22; 95% CI: 0.08-0.58).3 The
safety and tolerability of Alecensa in this trial were consistent
with previous trials in the metastatic setting and no unexpected
safety findings were observed.3 Overall survival data were immature
at the time of this analysis and follow-up is ongoing to report a
more mature estimate.3 The full results of ALINA are being
presented as a late-breaking oral at the European Society of
Medical Oncology (ESMO) Congress 2023 Presidential Symposium on
Saturday 21 October 2023. These data will be submitted to global
health authorities, including the U.S. Food and Drug Administration
and the European Medicines Agency.“By reducing the risk of
recurrence or death of ALK-positive early-stage NSCLC by an
unprecedented 76%, Alecensa can potentially alter the course of
this disease as we aim to provide the best chance for cure,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head
of Global Product Development. “We urgently need to do more to help
people with lung cancer, as about half of patients with early-stage
NSCLC experience disease recurrence. We’re working with health
authorities to bring Alecensa to patients in this setting as soon
as possible.”“These potentially practice-changing data reinforce
the potential of Alecensa as a new standard of care in the
ALK-positive early lung cancer setting where treatment options are
currently extremely limited,” said Professor Benjamin Solomon,
Medical Oncologist, Peter MacCallum Cancer Centre, Australia. “The
magnitude of disease-free survival observed in this study could
represent a paradigm shift in the way we manage early-stage
ALK-positive lung cancer.” Delaying disease progression is of
particular importance for people with ALK-positive NSCLC, who are
generally younger – usually around 55 – and are at higher risk of
developing brain metastases than those with other types of NSCLC.4
Once the disease returns it often spreads to other parts of the
body, at which point it is usually considered incurable.2,5
Comprehensive biomarker testing is essential to helping physicians
secure a complete, personalised diagnosis and identify the right
treatment for each patient.Results from the primary analysis of the
ALINA study showed median DFS was not yet reached for Alecensa
compared with 41.3 months for chemotherapy (95% CI: 28.5, not
evaluable [NE]) in patients with stage IB (tumour ≥4cm) to IIIA
disease.3 Grade 3 or 4 adverse events (AEs) occurred in 30% of
people receiving Alecensa, compared with 31% of those receiving
chemotherapy.3 No Grade 5 events were observed in either treatment
arm.3 For those receiving Alecensa, 5.5% of patients discontinued
treatment due to AEs versus 12.5% in the chemotherapy arm.3
About the ALINA studyThe 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 completely resected stage IB (tumour ≥4cm) to IIIA
(UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive
NSCLC. The study includes 257 patients who were randomly assigned
to either the investigational or control treatment arm. The primary
endpoint is disease-free survival. Secondary outcome measures
include overall survival and percentage of patients with adverse
events.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.About lung cancerLung cancer is one of the
leading causes of cancer death globally.6 Each year 1.8 million
people die as a result of the disease; this translates into more
than 4,900 deaths worldwide every day.6 Lung cancer can be broadly
divided into two major types: non-small cell lung cancer (NSCLC)
and small-cell lung cancer (SCLC). NSCLC is the most prevalent
type, accounting for around 85% of all cases.7 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.1 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.2About
Roche in lung cancerLung 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 thirteenth 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] Pignon JP et al. Lung
Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE
Collaborative Group. J Clin Oncol. 2008;26:3552-3559.[2] 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.[3] 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.[4] Griesinger F et al. Brain metastases in ALK-positive
NSCLC – time to adjust current treatment algorithms. Oncotarget.
2018:9(80);35181-35194.[5] Peters S et al. Alectinib versus
Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer.
NEJM. 2017;377:829-838.[6] Thandra K C, et al. Epidemiology of lung
cancer. Contemp Oncol. 2021;21(1):45-52.[7] American Cancer
Society: What Is Lung Cancer? [Internet; cited 2023 October]
Available
from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
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- 18102023_MR_ALINA data release_STAGE III_en
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