-
This Tecentriq combination is
the first cancer immunotherapy regimen approved for breast
cancer
-
Triple-negative breast cancer
is an aggressive disease, with high unmet medical need
Basel, 11 March 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that the US Food and Drug Administration
(FDA) has granted accelerated approval to Tecentriq® (atezolizumab)
plus chemotherapy (Abraxane® [paclitaxel protein-bound particles
for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with
unresectable locally advanced or metastatic triple-negative breast
cancer (TNBC) in people whose tumours express PD-L1, as determined
by an FDA-approved test. This indication is approved under
accelerated approval based on progression-free survival (PFS).
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s). The FDA's Accelerated Approval Programme allows
conditional approval of a medicine that fills an unmet medical need
for a serious or life-threatening disease or condition.
"The FDA approval of this Tecentriq combination is an important
treatment advance for people with PD-L1-positive, metastatic
triple-negative breast cancer, a disease with high unmet medical
need," said Sandra Horning, MD, Roche's Chief Medical Officer and
Head of Global Product Development. "This Tecentriq combination is
the first cancer immunotherapy regimen to be approved in breast
cancer, representing a meaningful step forward in the understanding
of this disease."
This accelerated approval is based on data from the Phase III
IMpassion130 study, which demonstrated that Tecentriq plus
nab-paclitaxel significantly reduced the risk
of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone (median PFS=7.4 vs. 4.8 months;
HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients
with unresectable locally advanced or metastatic TNBC who had not
received prior chemotherapy for metastatic disease. Overall
survival (OS) results were immature with 43% of events in all
randomised patients (intent-to-treat; ITT), and further data will
be shared with the FDA and presented at an upcoming medical
meeting. 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. The most common Grade
3-4 side effects (>=2%) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or
numbness in the hands and feet, neutrophil count decreased, feeling
tired, low red blood cells, low blood potassium level, pneumonia
and increased blood level of a liver enzyme (AST). The most common
side effects (>=20 %) were hair loss, feeling tired, tingling or
numbness in the hands and feet, nausea, diarrhoea, low red blood
cells, constipation, cough, headache, low white blood cells,
decreased appetite and vomiting.
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) in the ITT population and
in the PD-L1-positive population and OS in the ITT population. OS
results were immature in the ITT population. Secondary endpoints
include objective response rate and duration of response.
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;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.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 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 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 85 countries for people with previously treated
metastatic non-small cell lung cancer (NSCLC) and for certain
types of untreated or previously treated metastatic urothelial
carcinoma (mUC). Tecentriq was also recently approved in the United
States for the initial treatment of people with metastatic
non-squamous NSCLC with no EGFR or ALK genomic tumour
aberrations.
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 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 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.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a
wholly owned subsidiary of Celgene Corporation
References
[1] Breast Cancer Factsheet. World
Health Organization. Available from:
https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf
Accessed February 2019.
[2] Yao H et al. Triple-negative breast cancer: is there a
treatment on the horizon? Oncotarget.
2017;8(1):1913-1924.
[3] What is Triple-Negative Breast Cancer? BreastCancer.org.
Available from:
https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what
Accessed February 2019.
[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
February 2019.
[5] Pal SK et al. Triple negative breast cancer: unmet medical
needs. Breast Cancer Res Treat. 2011;125(3):627-636.
Roche Group Media Relations
Phone: +41 61 688
8888 / e-mail: media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
FDA grants Tecentriq in combination
with Abraxane accelerated approval