-
Triple-negative breast cancer
is an aggressive disease, with high unmet medical need
-
If approved, this Tecentriq
(atezolizumab) combination would be the first cancer immunotherapy
regimen for the treatment of PD-L1-positive, metastatic
triple-negative breast cancer
Basel, 13 November 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced the US Food and Drug Administration (FDA) has accepted
the company's supplemental Biologics License Application (sBLA) and
granted Priority Review for Tecentriq® (atezolizumab) plus
chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment
of unresectable locally advanced or metastatic triple-negative
breast cancer (TNBC) in people whose disease expresses the PD-L1
protein, as determined by PD-L1 biomarker testing. The FDA is
expected to make a decision on approval by 12 March 2019. A
Priority Review designation is granted to medicines that the FDA
has determined to have the potential to provide significant
improvements in the treatment, prevention or diagnosis of a
disease.
"Tecentriq in combination with nab-paclitaxel
has the potential to meaningfully advance treatment for people with
PD-L1-positive, metastatic triple-negative breast cancer. People
need more options for this type of breast cancer, which is
particularly difficult to treat," said Sandra Horning, MD, Roche's
Chief Medical Officer and Head of Global Product Development. "We
are working closely with the FDA to bring this Tecentriq
combination to people with PD-L1-positive metastatic
triple-negative breast cancer as soon as possible."
The sBLA is based on data from the Phase III IMpassion130 study,
which was presented at the European Society for Medical Oncology
(ESMO) Congress and published in the New England Journal of
Medicine in October 2018. Results demonstrate Tecentriq plus
nab-paclitaxel as an initial (first-line)
treatment for unresectable locally advanced or metastatic TNBC
significantly reduced the risk of disease worsening or death
(progression-free survival; PFS) compared with nab-paclitaxel alone in all randomised patients
(intention-to-treat [ITT]) (median PFS=7.2 vs. 5.5 months;
hazard ratio [HR]=0.80; 95% CI: 0.69-0.92, p=0.0025) and the
PD-L1-positive population (median PFS=7.5 vs 5.0 months; HR=0.62;
95% CI: 0.49-0.78, p<0.0001), a subgroup determined by PD-L1
biomarker testing.[1] At this
interim analysis, statistical significance was not met for overall
survival (OS) in the ITT population (median OS=21.3 vs 17.6 months;
HR=0.84; 95% CI: 0.69-1.02, p=0.0840), but the combination showed a
clinically meaningful OS improvement in the PD-L1-positive
population (median OS=25.0 vs 15.5 months; HR=0.62; 95% CI:
0.45-0.86).[1] Due to the hierarchical statistical design, results
in the PD-L1-positive population were not formally tested for
statistical significance. Follow-up will continue until the next
planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known
safety profiles of the individual medicines, and no new safety
signals were identified with the combination. Serious adverse
events were reported in 23% of people who received Tecentriq plus
nab-paclitaxel compared to 18% of people who
received nab-paclitaxel alone.[1]
Currently, Roche has seven ongoing Phase III studies investigating
Tecentriq in TNBC, including early and advanced stages of the
disease. If approved, this Tecentriq combination would be the first
cancer immunotherapy regimen for the treatment of PD-L1-positive,
metastatic TNBC.
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. 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. PFS and OS were
assessed in all randomised patients (ITT) and in the PD-L1-positive
population. Secondary endpoints include objective response rate,
duration of response and time to deterioration in Global Health
Status/Health-Related Quality of Life.
About TNBC
Breast cancer is
the most common cancer among women with more than 2 million
diagnosed worldwide each year.[2] 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.[3; 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.[6]
About Tecentriq
Tecentriq is
a monoclonal antibody designed to bind with a protein called PD-L1
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 has the potential to be used as a foundational
combination partner with cancer immunotherapies, targeted medicines
and various chemotherapies across a broad range of
cancers.
Tecentriq is already approved in the European Union, United States
and more than 80 countries for people with previously treated
metastatic NSCLC and for certain types of untreated or previously
treated metastatic urothelial carcinoma (mUC).
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a
wholly owned subsidiary of Celgene Corporation.
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 the HER2
-positive breast cancer. 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 and Kadcyla are
continuing to transform the treatment of early and advanced
HER2-postive breast cancer and, through our Tecentriq and
ipatasertib clinical programmes, we hope to bring new treatment
combinations to people with breast cancer, ultimately improving
outcomes.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing
medicines with the goal to redefine treatment in oncology. Today,
we're investing more than ever in our effort to bring innovative
treatment options that help a person's own immune system fight
cancer.
By applying our seminal research in immune tumour profiling within
the framework of the Roche-devised cancer immunity cycle, we are
accelerating and expanding the transformative benefits with
Tecentriq to a greater number of people living with cancer. Our
cancer immunotherapy development programme takes a comprehensive
approach in pursuing the goal of restoring cancer immunity to
improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy
please follow this link:
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. 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 tenth consecutive year, Roche has been
recognised as the most sustainable company 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 2017 employed about 94,000 people
worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and
posted sales of CHF 53.3 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 www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
[1] Schmid P et
al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative
Breast Cancer. N Engl J Med. 2018; DOI:
10.1056/NEJMoa1809615.
[2] Breast Cancer Factsheet. World Health Organization. Available
from:
http://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf.
Accessed November 2018.
[3] Yao H et al. Triple-negative breast cancer: is there a
treatment on the horizon? Oncotarget.
2017;8(1):1913-1924.
[4] Triple negative breast cancer risk factors. Cancer Treatment
Centers of America. Available from:
https://www.cancercenter.com/breast-cancer/risk-factors/tab/triple-negative-breast-cancer-risk-factors/.
Accessed November 2018.
[5] Pal SK et al. Triple negative breast cancer: unmet medical
needs. Breast Cancer Res Treat. 2011;125(3):627-636.
[6] What is Triple-Negative Breast Cancer? BreastCancer.org.
Available from:
https://www.breastcancer.org/symptoms/diagnosis/trip_neg/behavior.
Accessed November 2018.
therapies. Accessed October 2018..
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