Basel, 01 February 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced that the European Medicines Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) has
recommended the approval of Tecentriq® (atezolizumab), in
combination with Avastin® (bevacizumab), paclitaxel and
carboplatin, for the first-line treatment of adults with metastatic
non-squamous non-small cell lung cancer (NSCLC). In people with
EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with
Avastin, paclitaxel and carboplatin, is indicated only after
failure of appropriate targeted therapies. Based on the positive
CHMP recommendation, a final decision regarding the approval of
this Tecentriq-based combination is expected from the European
Commission in the near future.
The CHMP recommendation is based on results from the Phase III
IMpower150 study, which showed that Tecentriq in combination with
Avastin, paclitaxel and carboplatin helped people live
significantly longer, compared with Avastin and chemotherapy
(median overall survival [OS]=19.8 versus 14.9 months; hazard ratio
[HR]=0.76; 95%, CI: 0.63-0.93; p=0.006) in the intention-to-treat
(ITT) population.[1] The safety
profile of the Tecentriq combination was consistent with that
observed in previous studies.
"We are pleased to receive a positive opinion from the CHMP for
this Tecentriq-based combination, which represents a significant
step towards bringing a new treatment option to people across
Europe with advanced, non-squamous non-small cell lung cancer,"
said Sandra Horning, MD, Roche's Chief Medical Officer and Head of
Global Product Development. "The IMpower150 study, on which this
opinion is based, demonstrated an overall survival benefit,
including those in key populations such as people with EGFR- or
ALK-positive mutations or liver metastases."
About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled
Phase III study evaluating the efficacy and safety of Tecentriq in
combination with chemotherapy (carboplatin and paclitaxel) with or
without Avastin in people with stage IV or recurrent metastatic
non-squamous NSCLC who had not been treated with chemotherapy for
their advanced disease. A total of 1,202 people were enrolled and
randomised (1:1:1) to receive:
-
Tecentriq plus carboplatin and paclitaxel (Arm
A), or
-
Tecentriq and Avastin plus carboplatin and
paclitaxel (Arm B), or
-
Avastin plus carboplatin and paclitaxel (Arm C,
control arm).
The co-primary endpoints comparing Arms B and C
were OS and progression-free survival (PFS), as determined by the
investigator using Response Evaluation Criteria in Solid Tumours
Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation.
Key secondary endpoints included investigator-assessed PFS, OS and
safety in the ITT population.
A summary of the ITT data from the IMpower150 study that support
this recommendation is included below:[1]
-
Tecentriq in combination with Avastin and
chemotherapy helped people live significantly longer, compared with
Avastin and chemotherapy (median OS=19.8 versus 14.9 months;
HR=0.76; 95% CI: 0.63-0.93; p=0.006).
-
In addition, Tecentriq in combination with
Avastin and chemotherapy reduced the risk of disease worsening or
death (PFS) by 41% compared with Avastin and chemotherapy (HR=0.59;
95% CI: 0.50-0.69, p<0.0001).
-
Tecentriq in combination with Avastin and
chemotherapy shrank tumours (overall response rate [ORR]) in 56.4%
of people (95% CI: 51.4-61.4) compared with 40.2% of people (95%
CI: 35.3-45.2) on Avastin and chemotherapy.
-
The median duration of response (DoR) for people
receiving Tecentriq in combination with Avastin and chemotherapy
was 11.5 months (95%, CI: 8.9-15.7) compared with 6.0 months (95%
CI: 5.5-6.9) for people on Avastin and chemotherapy.
-
The most common adverse reactions (>=20%) in
people receiving Tecentriq in combination with Avastin and
chemotherapy were fatigue and lack of energy (asthenia; 50%), hair
loss (alopecia; 48%), nausea (39%), diarrhoea (32%), constipation
(30%), decreased appetite (29%), joint pain (arthralgia; 26%),
hypertension (25%), and pain from nerve damage (peripheral
neuropathy; 24%).
About NSCLC
Lung cancer is
the leading cause of cancer death globally.[2] Each
year 1.76 million people die as a result of the disease; this
translates into more than 4,800 deaths worldwide every
day.[2] Lung cancer
can be broadly divided into two major types: NSCLC and small cell
lung cancer. NSCLC is the most prevalent type, accounting for
around 85% of all cases.[3] NSCLC
comprises non-squamous and squamous-cell lung cancer, the squamous
form of which is characterised by flat cells covering the airway
surface when viewed under a microscope.[3]
About the Tecentriq
(atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support the
use of Tecentriq plus Avastin in combination. The Tecentriq and
Avastin regimen may enhance the potential of the immune system to
combat first-line advanced NSCLC. Avastin, in addition to its
established anti-angiogenic effects, may further enhance
Tecentriq's ability to restore anti-cancer immunity, by inhibiting
VEGF-related immunosuppression, promoting T cell tumour
infiltration and enabling priming and activation of T cell
responses against tumour antigens.
About Tecentriq (atezolizumab)
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.
Currently, Roche has nine Phase III lung cancer studies underway,
evaluating Tecentriq alone or in combination with other
medicines.
Tecentriq is already approved in the European Union, United States
and more than 85 countries for people with previously treated
metastatic NSCLC and for certain types of untreated or previously
treated metastatic urothelial carcinoma (mUC). Tecentriq in
combination with Avastin and chemotherapy 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 Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for
intravenous infusion. It is a biologic antibody designed to
specifically bind to a protein called vascular endothelial growth
factor (VEGF) that plays an important role throughout the lifecycle
of the tumour to develop and maintain blood vessels, a process
known as angiogenesis. Avastin is designed to interfere with the
tumour blood supply by directly binding to the VEGF protein to
prevent interactions with receptors on blood vessel cells. The
tumour blood supply is thought to be critical to a tumour's ability
to grow and spread in the body (metastasise).
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.
References
[1] Tecentriq
SmPC.
[2] GLOBOCAN 2018; Lung Cancer: Estimated cancer incidence,
mortality and prevalence worldwide. World Health Organization.
Available from:
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed January 2019.
[3] American Cancer Society; What Is Non-Small Cell Lung Cancer?
[Internet]: Available from:
https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
Accessed January 2019.
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
Roche-Media-Release-IMpower150_CHMP-opinion_EN