-
Approval based on significant
survival benefit of Tecentriq in combination with Avastin,
paclitaxel and carboplatin (chemotherapy) in people with metastatic
non-squamous non-small cell lung cancer (NSCLC) compared with
Avastin plus chemotherapy
-
New treatment option for EGFR
mutant or ALK-positive non-small cell lung cancer patients after
appropriate targeted therapy
Basel, 08 March 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that the European Commission has approved
and granted marketing authorisation for 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.
"Today's announcement makes the combination of Tecentriq, Avastin
and chemotherapy available to people in 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. "This approval includes EGFR mutant or ALK-positive
non-small cell lung cancer after failure of a targeted therapy
marking a first for this subgroup of patients, in which there is a
significant need for alternative treatment options."
This approval is based on results from the Phase III IMpower150
study, which showed that Tecentriq in combination with Avastin and
chemotherapy 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: 0.63-0.96; 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.
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
were 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 supported
this approval 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
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
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 February 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 February 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
Press Release (PDF)