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Press Release: CHMP recommends EU approval of -2-

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Press Release: CHMP recommends EU approval of Roche's Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer


Rozlytrek has shown durable responses across multiple tumour types,
including cancer that has spread to the brain, and could become Roche's
first tumour-agnostic therapy in Europe





Basel, 29 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced
that the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion under
conditional marketing authorisation for Rozlytrek(R) (entrectinib) for
the treatment of adult and paediatric patients 12 years of age and older
with solid tumours expressing a neurotrophic tyrosine receptor kinase
(NTRK) gene fusion, who have a disease that is locally advanced,
metastatic or where surgical resection is likely to result in severe
morbidity, and who have not received a prior NTRK inhibitor, who have no
satisfactory treatment options. The CHMP has also recommended Rozlytrek
for the treatment of adults with ROS1-positive, advanced non-small cell
lung cancer (NSCLC) not previously treated with ROS1 inhibitors.(1)



"Once approved, Rozlytrek could become Roche's first tumour-agnostic
therapy in Europe," said Levi Garraway, M.D., Ph.D., Roche's Chief
Medical Officer and Head of Global Product Development. "This milestone
therefore represents additional progress in personalised healthcare.
Based on genomic testing, Rozlytrek provides an effective first-line
treatment for many people whose cancers harbour NTRK or ROS1 gene
fusions, including tumours that have progressed to the brain."



The positive CHMP opinion is based on results from the integrated
analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase
I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.
Results showed:


Rozlytrek shrank tumours in more than half of people with NTRK
fusion-positive, locally advanced or metastatic solid tumours (overall
response rate [ORR]= 63.5%; N=74), and objective responses were observed
across 14 tumour types (median duration of response [DoR] = 12.9 months
[9.3 months not reached], N=21 out of 47).2

In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumours in 73.4% of
people with the disease (ORR; N=94 with 12 months follow up), with a
median DoR of 16.5 months (14.6 - 28.6 months). In a group of 161
patients with 6 months follow up, including 29% of patients with central
nervous system (CNS) metastases at baseline, ORR was observed to be
67.1%.1

Objective responses to Rozlytrek were seen in people with CNS metastases
at baseline, in both the NTRK and ROS1 populations.1,2

In paediatric patients, Rozlytrek shrank tumours (ORR) in all children
and adolescents who had NTRK gene fusions (N=5), with two achieving a
complete response (CR). Two patients with primary high-grade tumours in
the CNS had objective responses, including one patient with a CR.1

Across these studies, Rozlytrek was evaluated in several solid tumour
types, including sarcoma, non-small cell lung, salivary MASC, secretory
and non-secretory breast, thyroid, colorectal, neuroendocrine,
pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma,
gastrointestinal cancers and neuroblastoma.(1,2)



Rozlytrek was well tolerated. The most common adverse reactions (>=20
percent) with Rozlytrek were fatigue, constipation, altered sense of
taste (dysgeusia), swelling (oedema), dizziness, diarrhoea, nausea,
nervous system disorders (dysaesthesia), shortness of breath (dyspnoea),
anaemia, increased weight, increased blood creatinine, pain, cognitive
disorders, vomiting, cough, and fever (pyrexia).(1,2)



Rozlytrek has been granted Priority Medicines (PRIME) designation by the
EMA for the treatment of NTRK fusion-positive, locally advanced or
metastatic solid tumours in adult and paediatric patients who have
either progressed following prior therapies or who have no acceptable
standard therapies.(1) A final decision regarding the approval of
Rozlytrek by the European Commission is expected in the coming months.



Biomarker testing for NTRK gene fusions and ROS1 in NSCLC across all
solid tumours is the only way to identify people who are most eligible
for treatment with Rozlytrek. Roche is leveraging its expertise in
developing personalised medicines and advanced diagnostics, in
conjunction with Foundation Medicine, to develop a companion diagnostic
that will help identify people with NTRK and ROS1 gene fusions.



About the integrated analysis

The CHMP recommendation is based on an integrated analysis including
data from 74 people with locally advanced or metastatic NTRK
fusion-positive solid tumours (14 tumour types) and 161 people with
ROS1-positive NSCLC from the phase II STARTRK-2, phase I STARTRK-1 and
phase I ALKA-372-001 trials.(1,2) It is also based on data from the
phase I/II STARTRK-NG study in paediatric patients.(1) The studies
enrolled people across 15 countries and more than 150 clinical trial
sites. Safety was assessed from an integrated analysis of 504 people
across these four trials.(1,2)



About NTRK fusion-positive cancer

NTRK fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with
other genes, resulting in altered TRK proteins (TRKA/TRKB/TRKC) that can
activate signalling pathways involved in the proliferation of certain
types of cancer.(3) NTRK gene fusions are present in tumours
irrespective of site of origin. These fusions have been identified in a
broad range of solid tumour types, including sarcoma, non-small cell
lung, salivary MASC, secretory and non-secretory breast, thyroid,
colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma,
cholangiocarcinoma, gastrointestinal cancers and neuroblastoma.(2)



About ROS1-positive NSCLC

ROS1 is a tyrosine kinase, which plays a role in controlling how cells
grow and proliferate. When a ROS1 gene fusion occurs, cancer cells grow
and proliferate in an uncontrolled manner. Blocking this abnormal
signalling can cause tumour cells to shrink or die.(4) ROS1 gene fusions
account for 1-2% of non-small-cell lung cancer (NSCLC).(4) Lung cancer
is the leading cause of cancer-related death across the world.(5) Each
year, more than one and a half million people die as a result of the
disease globally, equating to more than 4,000 deaths every day.(5) NSCLC
is the most common type of lung cancer and accounts for up to 85% of all
lung cancer diagnoses.(6) While the ROS1 gene fusion can be found in any
patient with NSCLC, young never-smokers with NSCLC have the highest
incidence of ROS1 gene fusions.(4) About Rozlytrek

Rozlytrek(R) (entrectinib) is a tumour-agnostic, once-daily oral
medicine in development for the treatment of locally advanced or
metastatic solid tumours that harbour NTRK1/2/3 or ROS1 gene fusions. It
is a selective tyrosine kinase inhibitor designed to inhibit the kinase
activity of the TRK A/B/C and ROS1 proteins, whose activating fusions
drive proliferation in certain types of cancer.(7,8) Rozlytrek can block
NTRK and ROS1 kinase activity and may result in the death of cancer
cells with NTRK or ROS1 gene fusions.(7,8) Rozlytrek was granted
accelerated approval in August 2019 by the US Food and Drug
Administration (FDA), following receipt of Breakthrough Therapy
designation, for the treatment of adult and paediatric patients 12 years
of age and older with solid tumours that have a NTRK gene fusion without
a known acquired resistance mutation, are metastatic or where surgical
resection is likely to result in severe morbidity, and have progressed
following treatment or have no satisfactory alternative therapy, and was
approved for the treatment of adults with ROS1-positive, metastatic
NSCLC. In June 2019, Rozlytrek was also approved by Japan's Ministry of
Health, Labour and Welfare (MHLW) for the treatment of adult and
paediatric patients with NTRK fusion-positive, advanced recurrent solid
tumours, and was later approved in ROS1 positive NSCLC in February 2020.
Rozlytrek has also received approvals by health authorities in Australia,
Canada, Hong Kong, Israel and South Korea.(1) 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 five 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.



About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics under one roof have made Roche the
leader in personalised healthcare a strategy that aims to fit the
right treatment to each patient in the best way possible.



Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology
and diseases of the central nervous system. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics, and
a frontrunner in diabetes management.



Founded in 1896, Roche continues to search for better ways to prevent,
diagnose and treat diseases and make a sustainable contribution to
society. The company also aims to improve patient access to medical
innovations by working with all relevant stakeholders. More than thirty
medicines developed by Roche are included in the World Health
Organization Model Lists of Essential Medicines, among them life-saving
antibiotics, antimalarials and cancer medicines. Moreover, for the
eleventh consecutive year, Roche has been recognised as one of the most

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sustainable companies in the Pharmaceuticals Industry by the Dow Jones
Sustainability Indices (DJSI).



The Roche Group, headquartered in Basel, Switzerland, is active in over
100 countries and in 2019 employed about 98,000 people worldwide. In
2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF
61.5 billion. 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
https://www.globenewswire.com/Tracker?data=yHTj-4115fpqVRjTXcdX6OC34Cml1lvaxzbxkZhsFsPENl0eG5W_ru0RM4yNbBU_JZZSHyPr7UZtmexhKFYAIw
www.roche.com.



All trademarks used or mentioned in this release are protected by law.



References

[1] F. Hoffman La Roche Ltd. Data on file.

[2] Rolfo C, et al. Efficacy and safety of entrectinib in patients (pts)
with NTRK-fusion positive (NTRK-fp) solid tumors: An updated integrated
analysis. Presented at: American Society of Clinical Oncology Annual
Meeting; May 29, 2020; ASCO20 Virtual Scientific Program. Abstract 3605.

[3] Amatu A, Sartore-Bianchi A, Siena S. NTRK gene fusions as novel
targets of cancer therapy across multiple tumour types. ESMO Open.
2016;1(2):e000023.

[4] Bergethon K, Shaw AT, Ou SH, et al. ROS1 rearrangements define a
unique molecular class of lung cancers. J Clin Oncol. 2012;
30(8):863-70.

[5] GLOBOCAN. Lung Cancer. [Internet; cited 2020 May 27]. Available
from:

https://www.globenewswire.com/Tracker?data=4Xd6gtTdInQ6CuA3zahPel4Eay1qRLdxrhblPKY9V1VArwINY28BtZAXCR_jiv2GlCIV3DCSTpB95qURNnB_j8zJjS88m1DbgvjhRAjEdHNme6TQACowitETNScPMVvms7z8S_MVm4dgTF_zF88p8GsHdrh8aWmniqVsU_gt3icc9YEHs_VnGqBaAgn52blZ0FyZt161F-yDpPmGu2bYGNJBKWVClXQyj7mIBUfBfGQ=
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf

[6] American Cancer Society. What is Non-small Cell Lung Cancer?
[Internet; cited 2020 May 27]. Available from:
https://www.globenewswire.com/Tracker?data=4Xd6gtTdInQ6CuA3zahPeucd-afW8DJWMc8-qoFzJx9V12so3hyNCaOKxmkcAEHA87YYyD8mOjtCPfVTJfPyJwHQAglANUTZvWgZQPwWeQOtC6Of2RSGGzRlNPrFs1gnmqwb2lCJeedGJUchKVQAxzBjSnNWKJgQ9rToUOGJ_Pl-ILiFBAX2uCn6YyBUEg5p
https://www.cancer.org/cancer/lung-cancer/about/what-is.html

[7] Ahn M-J, Cho BC, Siena S, et al. Entrectinib in patients with
locally advanced or metastatic ROS1 fusion-positive non-small cell lung
cancer (NSCLC). Presented at: IASLC 18th World Conference on Lung
Cancer; October 15-18, 2017; Yokohama, Japan. Abstract 8564.

[8] Rolfo C, et al. Entrectinib: a potent new TRK, ROS1, and ALK
inhibitor. Expert Opin Investig Drugs. 2015;24(11):1493-500.





Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail:
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media.relations@roche.com

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- Patrick Barth

- Daniel Grotzky

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- Barbara von Schnurbein



Attachment


29052020_Roche_MediaRelease_CHMP recommends EU approval of Rozlytrek
https://ml-eu.globenewswire.com/Resource/Download/c2a121d7-5762-40ad-b5be-e0c6f669fe68








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