Roche’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
September 01 2023 - 1:00AM
Roche’s Alecensa delivers unprecedented Phase III results for
people with ALK-positive early-stage lung cancer
- ALINA data
demonstrate Alecensa reduces
disease recurrence in the early setting for people with
ALK-positive non-small cell lung cancer (NSCLC), building on its
long-established benefit in the advanced setting
- About half of people with
NSCLC experience disease recurrence following surgery, despite
adjuvant chemotherapy, therefore new treatments are urgently needed
to provide the best chance for cure
- These data will be
submitted to health authorities globally and
presented at an upcoming medical meeting
Basel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the Phase III ALINA study evaluating Alecensa®
(alectinib), compared with platinum-based chemotherapy, met its
primary endpoint of disease-free survival (DFS) at a prespecified
interim analysis. Alecensa demonstrated a statistically significant
and clinically meaningful improvement in DFS as adjuvant therapy 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). Alecensa is the first and only
ALK inhibitor to demonstrate a reduction in the risk of disease
recurrence or death for people with early-stage ALK-positive NSCLC
in a Phase III trial.
Overall survival (OS) data were immature at the time of this
analysis. No unexpected safety findings were observed. Results from
the ALINA study will be presented at an upcoming medical meeting
and submitted to health authorities globally, including the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA).
“Alecensa has transformed outcomes for people with advanced
ALK-positive NSCLC, and now these strong results provide evidence
for the first time that this medicine could also play a pivotal
role in early-stage disease where there is significant unmet need,”
said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and
Head of Global Product Development. “If approved, Alecensa has the
potential to treat cancer before it has spread in a setting where
treatment can increase the chances of cure, which is our ultimate
goal at Roche. We look forward to sharing these data with
regulatory authorities in hopes of bringing this to patients as
quickly as possible.”
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 Recent treatment
innovations, including immunotherapies, have improved the outlook
for some patients with early-stage NSCLC; however, there are no
approved ALK inhibitors for early-stage ALK-positive disease.2
Approximately five percent of people with NSCLC are ALK-positive.3
ALK-positive NSCLC is often found in younger people – usually 55
and under – who have a light or non-smoking history.4,5 National
Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) recommend biomarker testing of
resected surgical tissue or biopsy for ALK rearrangements in
patients with stage IB to IIIA and IIIB NSCLC, in addition to in
the advanced setting.
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 non-small cell lung cancer (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 (DFS). Secondary outcome measures include
overall survival (OS) 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 now approved in over 100 countries as an
initial (first-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.About 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] Yano T, et al. Therapeutic
strategy for postoperative recurrence in patients with non-small
cell lung cancer. World J Clin Oncol. 2014;5(5):1048-1054.[2] Chen
M F, et al. Early-stage anaplastic lymphoma kinase (ALK)-positive
lung cancer: a narrative review. Transl Lung Cancer Res.
2023;12(2):337-345.[3] Chia P L, et al. 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;20(6):423–432.[4] Lung Cancer Foundation of America: What is
ALK positive lung cancer? And what are the options for treatment?
[Internet; cited 2023 August]. Available from:
https://lcfamerica.org/lung-cancer-info/types-lung-cancer/alk-positive-lung-cancer/.[5]
Arbour K C, et al. Diagnosis and Treatment of ALK Positive NSCLC.
Hematol Oncol Clin North Am. 2017;31(1):101-111.[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 August] 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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