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Press Release: Roche presents new data from -2-

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Press Release: Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020



Data from the Phase III IMpassion031 study demonstrated that Tecentriq in
combination with chemotherapy improved pathological complete response for
patients with early triple-negative breast cancer (TNBC), when compared
to placebo plus chemotherapy

Final overall survival data from the Phase III IMpassion130 study were
consistent with prior interim analyses in patients with metastatic TNBC,
whose tumours expressed PD-L1 and who received Tecentriq plus
nab-paclitaxel

Results from the Phase III IMpassion131 study, evaluating Tecentriq in
combination with paclitaxel for the treatment of people with metastatic
TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint
of progression-free survival

Basel, 19 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced that it presented the latest results from three Phase III
studies from the Tecentriq(R) (atezolizumab) clinical development
programme in triple-negative breast cancer (TNBC) at the European
Society for Medical Oncology (ESMO) Virtual Congress 2020.



"While we have made great progress in the treatment of many forms of
breast cancer, TNBC remains an aggressive and difficult-to-treat disease,
" said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and
Head of Global Product Development. "We are proud of our work to address
challenges and advance scientific understanding of cancer immunotherapy
in the context of distinct chemotherapy regimens and in various TNBC
treatment settings. Although the IMpassion131 study did not reach its
endpoint, we are pleased to bring new treatment options for some TNBC
patients, and remain committed to improving the lives of all women with
early and advanced stages of this disease."



Results from the Phase III IMpassion031 study, evaluating Tecentriq in
combination with chemotherapy (Abraxane(R), albumin-bound paclitaxel;
nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in
comparison to placebo plus chemotherapy (including nab-paclitaxel),
demonstrated a statistically significant and clinically meaningful
improvement in pathological complete response (pCR) for the treatment of
people with early TNBC, regardless of PD-L1 expression. pCR was observed
in 57.6% (95% CI: 49.765.2) of patients treated with Tecentriq in
combination with chemotherapy, an increase of 16.5% from 41.1% (95% CI:
33.648.9) in patients treated with placebo plus chemotherapy
(one-sided p=0.0044, significance boundary = 0.0184) in the
intention-to-treat (ITT) population. The safety profile was consistent
with the established profile of the individual drugs and no new safety
concerns were identified.



The IMpassion031 study is the second positive Phase III study from Roche
demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq
study to demonstrate benefit in early TNBC. Tecentriq in combination
with nab-paclitaxel is currently approved in more than 70 countries
worldwide, including the US and across Europe, for the treatment of
adults with unresectable locally advanced or metastatic TNBC in people
whose tumours express PD-L1 (IC>=1%).



The final overall survival (OS) analysis of the Phase III IMpassion130
study, evaluating Tecentriq in combination with nab-paclitaxel, compared
with placebo plus nab-paclitaxel, as a first-line treatment for patients
with metastatic TNBC, was consistent with the first and second interim
analyses. There was no significant difference in OS between the
treatment groups in the ITT population. Clinically meaningful
improvements in OS were seen with Tecentriq plus nab-paclitaxel in
PD-L1-positive patients. The magnitude of OS improvements with Tecentriq
in PD-L1-positive patients remained clinically meaningful, with an
increase of 7.5 months in median OS with Tecentriq plus nab-paclitaxel,
compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95%
CI: 0.530.86). However, this result could not be formally tested due
to the prespecified statistical testing hierarchy. The cumulative safety
of the Tecentriq plus nab-paclitaxel combination remains consistent with
the previously reported safety data for this study and the known risks
of individual study drugs. No new safety concerns were identified with
longer follow-up.



Finally, results from the Phase III IMpassion131 study, evaluating
Tecentriq in combination with paclitaxel, compared with placebo plus
paclitaxel, as a first-line treatment for patients with metastatic TNBC,
did not show significant improvement for progression-free survival in
the PD-L1-positive population (HR=0.82; 95% CI: 0.601.12). The OS data
showed a negative trend; however, the study was not powered for the
secondary endpoint of OS, and OS data were immature at time of analysis
(initial HR=1.55 [95% CI: 0.86-2.80] in the PD-L1 positive population,
based on 21% of patients with an event; updated HR=1.12 [95% CI:
0.76-1.65]), updated analysis based on 41% of patients with an event).
The safety profile of Tecentriq plus paclitaxel was consistent with the
established safety profile of the individual study drugs and no new
safety concerns were identified.



Roche has an extensive development programme for Tecentriq, including
multiple ongoing and planned Phase III studies across several types of
lung, genitourinary, skin, breast, gastrointestinal, gynaecological and
head and neck cancers. This includes studies evaluating Tecentriq both
alone and in combination with other medicines.



About the IMpassion031 study

The IMpassion031 study is a Phase III, multicentre, randomised,
double-blind study evaluating the efficacy and safety of Tecentriq
(atezolizumab) in combination with chemotherapy (Abraxane(R),
albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and
cyclophosphamide) in comparison to placebo plus chemotherapy, in people
with previously untreated, early TNBC. The study enrolled 333 people who
were randomised in a 1:1 ratio to receive Tecentriq or placebo plus
chemotherapy in the neoadjuvant (before surgery) setting. Treatment with
Tecentriq continued adjuvantly (after surgery) for those in the
Tecentriq arm of the study. The primary endpoint is pCR using the
American Joint Committee on Cancer (AJCC) staging system in the ITT
population and in the PD-L1-positive population. Secondary endpoints
include OS, event-free survival, disease-free survival and quality of
life measures.

About the IMpassion130 study

The IMpassion130 study is a Phase III, multicentre, randomised,
double-blind study evaluating the efficacy, safety, and pharmacokinetics
of Tecentriq plus nab-paclitaxel compared with placebo plus
nab-paclitaxel in people with unresectable locally advanced or
metastatic TNBC who have not received prior systemic therapy for
metastatic breast cancer (mBC). The study enrolled 902 people who were
randomised equally (1:1). The co-primary endpoints are PFS per
investigator assessment (RECIST 1.1) and OS in the ITT population and in
the PD-L1-positive population. Secondary endpoints include objective
response rate and duration of response.



About the IMpassion131 study

The IMpassion131 study is a Phase III, multicentre, randomised,
double-blind study evaluating the efficacy and safety of Tecentriq in
combination with paclitaxel, in comparison to placebo plus paclitaxel,
in people with previously untreated, inoperable, locally advanced or
metastatic TNBC. The study enrolled 651 people who were randomised in a
2:1 ratio to receive Tecentriq or placebo plus paclitaxel. The primary
endpoint is PFS per investigator assessment (RECIST 1.1) in the
PD-L1-positive population followed by ITT populations. Secondary
endpoints include OS, ORR and duration of response in the PD-L1-positive
and ITT populations.



About triple-negative breast cancer

Breast cancer is the most common cancer among women with more than 2
million diagnosed worldwide each year.(1) TNBC represents 15% of all
breast cancers and is more common in women under the age of 50, compared
with other forms of breast cancer.(2-4) It is defined by the lack of
expression and/or amplification of the targetable receptors for
oestrogen, progesterone and HER2 amplification.(5) Patients with
metastatic TNBC generally experience rapid progression and shorter OS
compared to other subtypes of breast cancer.(3) About Roche in breast
cancer

Roche has been advancing breast cancer research for more than 30 years
with the goal of helping as many people with the disease as possible.
Our medicines, along with companion diagnostic tests, have contributed
to bringing breakthrough innovations in HER2-positive and triple
negative breast cancers. As our understanding of breast cancer biology
rapidly improves, we are working to identify new biomarkers and
approaches to treatment for all forms of early and advanced breast
cancer, including triple-negative and hormone receptor-positive.



Our targeted medicines Herceptin, Perjeta, Kadcyla and Tecentriq are
continuing to transform the treatment of early and advanced
HER2-positive and triple negative breast cancers and, through our
Tecentriq and ipatasertib clinical programmes, we hope to bring new
treatment combinations to people with breast cancer, ultimately
improving outcomes.

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein
called PD-L1, which is expressed on tumour cells and tumour-infiltrating
immune cells, blocking its interactions with both PD-1 and B7.1
receptors. By inhibiting PD-L1, Tecentriq may enable the activation of
T-cells. Tecentriq is a cancer immunotherapy that has the potential to
be used as a foundational combination partner with other immunotherapies,
targeted medicines and various chemotherapies across a broad range of
cancers. The development of Tecentriq and its clinical programme is

(MORE TO FOLLOW) Dow Jones Newswires

September 19, 2020 10:20 ET ( 14:20 GMT)


based on our greater understanding of how the immune system interacts
with tumours and how harnessing a person's immune system combats cancer
more effectively.



Tecentriq is approved in the US, EU and countries around the world,
either alone or in combination with targeted therapies and/or
chemotherapies in various forms of non-small cell and small cell lung
cancer, certain types of metastatic urothelial cancer and in
PD-L1-positive metastatic triple-negative breast cancer. In the US,
Tecentriq in combination with Avastin is approved for people with
unresectable or metastatic HCC.



About Roche in cancer immunotherapy

Roche's rigorous pursuit of groundbreaking science has contributed to
major therapeutic and diagnostic advances in oncology over the last 50
years, and today, realising the full potential of cancer immunotherapy
is a major area of focus. With over 20 molecules in development, Roche
is investigating the potential benefits of immunotherapy alone, and in
combination with chemotherapy, targeted therapies or other
immunotherapies with the goal of providing each person with a treatment
tailored to harness their own unique immune system to attack their
cancer. Our scientific expertise, coupled with innovative pipeline and
extensive partnerships, gives us the confidence to continue pursuing the
vision of finding a cure for cancer by ensuring the right treatment for
the right patient at the right time.



In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq(R)
(atezolizumab), Roche's broad cancer immunotherapy pipeline includes
other checkpoint inhibitors, such as tiragolumab, a novel cancer
immunotherapy designed to bind to TIGIT, individualised neoantigen
therapies and T-cell bispecific antibodies. To learn more about Roche's
scientific-led approach to cancer immunotherapy, please follow this
link:

https://www.globenewswire.com/Tracker?data=uUP7GdtotpUXrC6WCZRVJz65P_b3JHj1HLwoabAd72Egt0dCl9WpnAvK1SA3xn1IGrlsd2nwckIperaEX4dn53K41VRjvI3ZGIry0RFnSMM2LkNfb62ZxsdIf7DmYCvDnBGfIYcYQL4lDc8-MVqtdhyMq1oFqlB3iYPqdV990dpU8frBVJZ9yCXAz9fBecGgB7OpHnQ1y4ac5JQn-0vquhWDLVvhFcPGLOBqOOopiKBjBrjVsXFN2L3dmgaoPzC965hi4xk2guJG5jYggNhYfH3nKIE8SpDSSiAe3cCD2R1SNm0T-q7LMbxTlJ2VoGnT
http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm




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
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=gMCVagcih8dzrQJc8EyrvndES3Ni_4qSJ6EAVHtvw47gHzHBSDFexwahcDqIFM0hlTnajiAYecmd_1K3R8jLhg
www.roche.com.



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



References

[1]World Health Organization: Globocan 2018 Breast Cancer Factsheet.
[Internet; cited 24 July] Available from:
http://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf.


[2] Yao H et al. Triple-negative breast cancer: is there a treatment on
the horizon? Oncotarget. 2017;8(1):19131924.

[3] BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet;
cited 24 July] Available from:
https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what.

[4] Cancer Treatment Centers of America. Triple negative breast cancer
risk factors. [Internet; cited 24 July] Available from:
https://www.cancercenter.com/breast-cancer/risk-factors/tab/triple-negative-breast-cancer-risk-factors/.


[5] Pal SK et al. Triple negative breast cancer: unmet medical needs.
Breast Cancer Res Treat. 2011;125(3):627636.





Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail:
https://www.globenewswire.com/Tracker?data=7e-4_ee7aaFqwI-W30hN9b706KAtwSGKqz9wIhRLO3nsZNBIJjWZf7LkdpXBTxD_-WXJRO5SrHIo32gVMvM-FVgG1Fh4ZAfQv_5ZeSkrjfnK33H3fiP0Ph_9PoshlIkg
media.relations@roche.com








Dr. Nicolas Dunant Patrick Barth
Phone: +41 61 687 05 17 Phone: +41 61 688 44 86
Dr. Daniel Grotzky Karsten Kleine
Phone: +41 61 688 31 10 Phone: +41 61 682 28 31
Nina Mählitz Nathalie Meetz
Phone: +41 79 327 54 74 Phone: +41 61 687 43 05
Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67








Roche Investor Relations
Dr. Karl Mahler Jon Kaspar Bayard
Phone: +41 61 68-78503 Phone: +41 61 68-83894
e-mail: mailto:karl.mahler@roche.com e-mail: mailto:jon_kaspar.bayard@roche.com
karl.mahler@roche.com jon_kaspar.bayard@roche.com

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

Dr. Birgit Masjost Dr. Gerard Tobin
Phone: +41 61 68-84814 Phone: +41 61 68-72942
e-mail: mailto:birgit.masjost@roche.com e-mail: mailto:gerard.tobin@roche.com
birgit.masjost@roche.com gerard.tobin@roche.com


Investor Relations North America
Loren Kalm Dr. Lisa Tuomi
Phone: +1 650 225 3217 Phone: +1 650 467 8737
e-mail: mailto:kalm.loren@gene.com e-mail: mailto:tuomi.lisa@gene.com
kalm.loren@gene.com tuomi.lisa@gene.com





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(END) Dow Jones Newswires

September 19, 2020 10:20 ET ( 14:20 GMT)
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