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 study(1)
  * 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 chemotherapy(2)
  * Early diagnosis and treatment of lung cancer can reduce the burden

associated with progressive disease and give people the best possible chance of cure(3-6)
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 (7?? 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= 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 (https://clinicaltrials.gov/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 7(th) 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 (7??
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 (http://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.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
(mailto:media.relations@roche.com)

  Hans Trees, PhD           Sileia Urech
  Phone: +41 79 407 72 58   Phone: +41 79 935 81 48
  Nathalie Altermatt        Simon Goldsborough
  Phone: +41 79 771 05 25   Phone: +44 797 32 72 915
  Karsten Kleine            Nina Mählitz
  Phone: +41 79 461 86 83   Phone: +41 79 327 54 74
  Kirti Pandey              Yvette Petillon
  Phone: +49 172 6367262    Phone: +41 79 961 92 50
  Dr. Rebekka Schnell
  Phone: +41 79 205 27 03

Roche Investor Relations

 Dr. Bruno Eschli                        Dr. Sabine Borngräber
 Phone: +41 61 68-75284                  Phone: +41 61 68-88027
 e-mail: bruno.eschli@roche.com          e-mail: sabine.borngraeber@roche.com
 (mailto:bruno.eschli@roche.com)         (mailto:sabine.borngraeber@roche.com)

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
(mailto:birgit.masjost@roche.com)
Investor Relations North America

  Loren Kalm
  Phone: +1 650 225 3217
  e-mail: kalm.loren@gene.com (mailto:kalm.loren@gene.com)

Â