FDA approves Roche’s Alecensa as the first adjuvant treatment for
people with ALK-positive early-stage lung cancer
- Approval based on Phase III ALINA study showing
Alecensa reduced the risk of disease recurrence or death by an
unprecedented 76% in people with ALK-positive early-stage resected
non-small cell lung cancer
(NSCLC)1
- This approval helps address an urgent unmet need,
with about half of
people living with early-stage NSCLC experiencing disease
recurrence following surgery, despite adjuvant
chemotherapy2
- The
National Comprehensive Cancer Network® (NCCN®)
Guidelines recommend routine testing for ALK, EGFR and
PD-L1 biomarkers in people with early-stage NSCLC to inform
adjuvant therapy selection
Basel, 19 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the U.S. Food and Drug Administration (FDA)
has approved Alecensa® (alectinib) for adjuvant treatment following
tumour resection for patients with anaplastic lymphoma kinase
(ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥ 4 cm
or node positive), as detected by an FDA-approved test. Alecensa is
now the first and only ALK inhibitor approved for people with
ALK-positive early-stage NSCLC who have undergone surgery to remove
their tumour.
“With an unprecedented 76% reduction in the risk of disease
recurrence or death versus chemotherapy, Alecensa significantly
improves upon the standard of care for people with early-stage
ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development. “At
Roche, our goal is to give patients the best chance of cure by
bringing effective, targeted treatments to early-stage disease
before their cancer has spread. This approval brings us one step
closer to achieving that mission.”
“The approval of Alecensa marks a pivotal moment for people
newly diagnosed with early-stage ALK-positive lung cancer, who
until now, were not able to receive ALK-specific therapy,” said Ken
Culver, Director of Research and Clinical Affairs at ALK Positive,
Inc. "These patients, who are typically diagnosed at a younger age,
often face recurrence and have a higher risk of developing brain
metastases than those with other types of NSCLC. Now, with this
significant advance, it is more important than ever that all people
diagnosed with early-stage lung cancer undergo testing for ALK and
other recommended biomarkers to receive the treatment most
appropriate for them.”
The approval is based on positive results from the Phase III
ALINA study that demonstrated Alecensa reduced the risk of disease
recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI:
0.13-0.43, p<0.001) 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
(CNS) disease-free survival was observed (HR=0.22; 95% CI:
0.08-0.58).1 The safety and tolerability of Alecensa in
this trial were generally consistent with previous trials in the
metastatic setting and no unexpected safety findings were
observed.1 These data were presented as a late-breaking
oral at the European Society of Medical Oncology Congress 2023
Presidential Symposium in October 2023 and were also recently
published in the New England Journal of Medicine in April 2024.
Alecensa is a kinase inhibitor currently approved as first- and
second-line treatment for ALK-positive metastatic NSCLC. It has
demonstrated significant efficacy in patients, including those with
CNS metastases, and now with this approval, these benefits could
extend to people with early-stage disease. 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® (NCCN®) Clinical Practice
Guidelines in Oncology (NCCN Guidelines®), to support clinicians’
decision-making. About 5% of people with NSCLC are ALK-positive,
equating to approximately 90,000 people worldwide diagnosed each
year.3-5
The review of this application was conducted under the FDA’s
Project Orbis initiative, which provides a framework for concurrent
submission and review of oncology medicines among international
partners. According to the FDA, collaboration among international
regulators may allow patients with cancer to receive earlier access
to products in other countries where there may be significant
delays in regulatory submissions. For this review, FDA collaborated
with the Australian Therapeutics Goods Administration (TGA), Health
Canada (HC), Israel’s Ministry of Health (IMoH) Pharmaceutical
Administration, Switzerland’s Swissmedic, and the United Kingdom’s
Medicines and Healthcare Products Regulatory Agency (UK MHRA).
Brazil's National Health Surveillance Agency (ANVISA) and
Singapore’s Health Sciences Authority (HSA) will also be
participating as Type C Project Orbis Partners. Additionally, the
FDA reviewed and approved the supplemental application under its
Real-Time Oncology Review pilot programme, which aims to explore a
more efficient review process to ensure safe and effective
treatments are available to patients as early as possible. Data
from the Phase III ALINA study will also be used for filing
submissions to additional global health authorities, including the
European Medicines Agency
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 (DFS). Secondary outcome measures include
overall survival, central nervous system-DFS, and percentage of
patients with adverse events.
About lung cancer
Lung 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. 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.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.8
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 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] Wu Y-L et al. Alectinib in Resected ALK-Positive Non–Small-Cell
Lung Cancer. NEJM. 2024;390:1265-1276.
[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] Barlesi, et al. Routine molecular profiling of patients with
advanced non-small-cell lung cancer: results of a 1-year nationwide
programme of the French Cooperative Thoracic Intergroup (IFCT).
Lancet 2016. 387(10026):1415-1426.
[4] Tian, et al. Clinical characteristics and sequence complexity
of anaplastic lymphoma kinase gene fusions in Chinese lung cancer
patients. Lung Cancer 2017. 114:90-95.
[5] Cancer.Net®. Lung Cancer - Non-Small Cell: Statistics.
[Internet; cited April 2024]. Available from:
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
[6] Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol.
2021;21(1):45-52.
[7] 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.
[8] 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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