Basel, 17 January 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced that the US Food and Drug
Administration (FDA) has accepted the company's supplemental
Biologics License Application (sBLA) for Tecentriq® (atezolizumab)
in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial
(first-line) treatment of people with metastatic non-squamous
non-small cell lung cancer (NSCLC) who do not have EGFR or ALK
genomic tumour aberrations. The FDA is expected to make a decision
on approval by 2 September 2019.
"We look forward to working with the FDA in order to bring this
Tecentriq-based combination to people with non-squamous non-small
cell lung cancer as soon as possible," said Sandra Horning, MD,
Roche's Chief Medical Officer and Head of Global Product
Development. "Lung cancer is a challenging disease to treat, and
this review takes us one step closer towards offering a new
treatment option that has shown a clinically meaningful survival
benefit in the treatment of this type of disease."
This sBLA is based on results from the Phase III IMpower130 study,
which met its co-primary endpoints of overall survival (OS) and
progression-free survival (PFS) in the initial treatment of people
with metastatic non-squamous NSCLC.
The FDA recently approved Tecentriq in combination with Avastin,
paclitaxel and carboplatin (chemotherapy) for the initial treatment
of people with metastatic non-squamous NSCLC with no EGFR or ALK
genomic tumour aberrations. Tecentriq is also approved by the FDA
to treat people with metastatic NSCLC who have disease progression
during or following platinum-containing chemotherapy. Patients with
EGFR or ALK genomic tumour aberrations should have disease
progression on FDA approved therapy for NSCLC harbouring these
aberrations prior to receiving Tecentriq.
About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised
study evaluating the efficacy and safety of Tecentriq in
combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and
nab-paclitaxel) alone for chemotherapy-naïve
patients with stage IV non-squamous NSCLC. The study enrolled 724
people who were randomised in a 2:1 ratio to receive:
-
Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
-
Nab-paclitaxel and
carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received
Tecentriq and carboplatin on day 1 of each 21-day cycle, and
nab-paclitaxel on days 1, 8 and 15 of each
21-day cycle for 4 or 6 cycles or until loss of clinical benefit,
whichever occurred first. People in Arm A received Tecentriq during
the maintenance treatment phase until loss of clinical benefit was
observed.
During the treatment-induction phase, people in Arm B received
carboplatin on day 1 and nab-paclitaxel on
days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until
disease progression, whichever occurred first. People in Arm B
received best supportive care during the maintenance treatment
phase. Switch maintenance to pemetrexed was also permitted. People
who were consented prior to a protocol revision were given the
option to crossover following disease progression to receive
Tecentriq as monotherapy until further disease
progression.
The co-primary endpoints were:
-
PFS as determined by the investigator using
RECIST v1.1 in people without EGFR or ALK mutations, assessed in
the ITT-WT population
-
OS in the ITT-WT population
The IMpower130 study met its OS and PFS co-primary endpoints as per
the study protocol. The interim analysis showed that Tecentriq plus
chemotherapy helped people live significantly longer compared with
chemotherapy alone (median OS=18.6 versus 13.9 months; hazard ratio
[HR]=0.79; 95% CI: 0.64-0.98; p=0.033) in the intention-to-treat
wild-type (ITT-WT) population.[1] The Tecentriq-based combination
also significantly reduced the risk of disease worsening or death
(PFS) compared with chemotherapy alone (median PFS=7.0 versus 5.5
months; HR=0.64; 95% CI: 0.54-0.77; p<0.0001) in the ITT-WT
population. [1] Safety for the Tecentriq plus chemotherapy
combination appeared consistent with the known safety profiles of
the individual medicines, and no new safety signals were identified
with the combination. Grade 3-4 treatment-related adverse events
(AEs) were reported in 73.2% of people receiving Tecentriq plus
chemotherapy compared to 60.3% of people receiving chemotherapy
alone.
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
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 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 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 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] Capuzzo F et
al. IMpower130: Progression-free survival (PFS) and safety analysis
from a randomised phase 3 study of carboplatin + nab-paclitaxel
(CnP) with or without atezolizumab (atezo) as first-line (1L)
therapy in advanced non-squamous NSCLC. Presented at: European
Society for Medical Oncology's (ESMO) 2018 Conference on 22 October
2018, Munich, Germany. Abstract #LBA53.
[2] World Health Organization. GLOBOCAN 2018; Lung Cancer:
Estimated cancer incidence, mortality and prevalence worldwide.
[Internet]:
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]:
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
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