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Media Release
Basel, 18 February 2017
Phase II study supports potential for Roche’s TECENTRIQ (atezolizumab) plus
Avastin (bevacizumab) for people with locally advanced or metastatic renal cell
carcinoma

Proof of concept study in first line mRCC (a type of kidney cancer) shows that TECENTRIQ and
Avastin can be combined with a manageable safety profile

Study results also showed encouraging efficacy compared to sunitinib in those people whose disease
expressed the PD-L1 (programmed death-ligand 1) protein

Roche is evaluating TECENTRIQ plus Avastin in a Phase III study (IMmotion151) in people with
previously untreated, locally advanced or metastatic RCC
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced encouraging results from the Phase II
IMmotion150 study that compared TECENTRIQ® (atezolizumab) plus Avastin® (bevacizumab) and
TECENTRIQ monotherapy to sunitinib alone in people with previously untreated, locally advanced or
metastatic renal cell carcinoma (mRCC). These results were presented at the 2017 Genitourinary Cancers
Symposium taking place from February 16-18 in Florida, USA. IMmotion150 is the first randomised clinical
trial to evaluate the combination of TECENTRIQ and Avastin in mRCC. The study was designed to inform
further clinical development of this combination and these study results reinforce the potential of this
combination in this setting.
The study showed that people whose disease expressed PD-L1 (programmed death-ligand 1) and were
treated with TECENTRIQ plus Avastin had a 36 percent reduction in the risk of their disease worsening or
death compared to people treated with sunitinib alone (median progression-free survival [mPFS]: 14.7 vs. 7.8
months; HR= 0.64; 95% CI 0.38, 1.08). No PFS advantage was observed compared to sunitinib in the
intention-to-treat [ITT] population (mPFS: 11.7 vs. 8.4 months; HR = 1.00; 95% CI 0.69, 1.45). Median
Duration of Response (DoR) has not yet been reached after 20.7 months of follow-up across treatment
arms. Adverse events in the TECENTRIQ plus Avastin arm were consistent with those observed in previous
studies of each medicine.
F. Hoffmann-La Roche Ltd
4070 Basel
Switzerland
Group Communications
Roche Group Media Relations
Tel. +41 61 688 88 88
www.roche.com
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“These Phase II results support the scientific rationale for potentially combining TECENTRIQ and Avastin
in people with this type of kidney cancer,” said Sandra Horning, MD, Chief Medical Officer and Head of
Global Product Development. “There is a significant need for new treatment options for people living with
advanced RCC, a disease where currently only about one in 10 people are alive beyond five years following
diagnosis.”
Roche is also evaluating TECENTRIQ plus Avastin vs sunitinib in a Phase III study (IMmotion151;
NCT02420821) in people with previously untreated, locally advanced or metastatic RCC. A study of
TECENTRIQ as adjuvant treatment for RCC began enrolling earlier this year.
About the IMmotion150 study
IMmotion150 is a global, multicentre, open-label, randomised Phase II study that was designed to evaluate
the efficacy and safety of TECENTRIQ plus Avastin (Arm A), TECENTRIQ alone (Arm B) or sunitinib alone
(Arm C) in 305 patients with previously untreated, locally advanced or metastatic RCC. People in Arm A
received TECENTRIQ administered intravenously at 1200 mg every 3 weeks (6-week cycles) plus Avastin
intravenously at 15 mg until disease progression or lack of clinical benefit. People in Arm B received
TECENTRIQ alone (until disease progression or lack of clinical benefit), and people in Arm C received
sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression.
The co-primary endpoints were PFS per RECIST v.1.1 via Independent Review Facility (IRF) assessment in
all randomised patients (ITT population) and in the PD-L1 selected (IC1/2/3) subgroup. PD-L1 expression
was assessed on tumour-infiltrating immune cells (IC) with an investigational immunohistochemistry (IHC)
test based on the SP142 antibody being developed by Roche Tissue Diagnostics. Secondary endpoints
included IRF-assessed overall response rate (ORR) and duration of response (DoR), investigator-assessed
PFS, ORR, DoR and safety, and overall survival (OS). A summary of the efficacy data from Arms A, B and C
of the IMmotion150 study is included below.
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IMmotion150 primary analysis efficacy results by IRF
IC1/2/3 subgroup
(PD-L1 expression on >1% IC)
Treatment
TECENTRIQ + sunitinib TECENTRIQ
Avastin
(n=60)
(n=54)
(n=50)
Median PFS,
14.7
7.8
5.5
months
Stratified HR*
0.64
1.03
(95% CI)
(0.38, 1.08)
(0.63, 1.67)
ITT population
TECENTRIQ +
Avastin
(n=101)
11.7
sunitinib
(n=101)
TECENTRIQ
(n=103)
8.4
6.1
1.00
(0.69, 1.45)
-
1.19
(0.82, 1.71)
Stratified logrank p value*
0.0952
-
0.9172
0.9819
-
0.3580
Overall
Response Rate
(ORR)
Complete
Responses
(CR)
Duration of
Response
(DoR)
46%
27%
28%
32%
29%
25%
12%
7%
15%
7%
5%
11%
N.E
N.E
N.E
N.E
N.E
N.E
CI, confidence interval; HR, hazard ratio.
* Relative to sunitinib
p-values provided for descriptive purposes only and not adjusted for multiple comparisons
IMmotion150 was designed with planned crossover. Over three quarters (78 percent) of sunitinib patients
(Arm C) who progressed subsequently received TECENTRIQ plus Avastin (Arm A) OS results were
immature at time of analysis with only 35 percent of events having occurred.
Safety in the TECENTRIQ plus Avastin arm appeared consistent with the known safety profile of the
individual medicines. No new safety signals were identified. Frequency of all-grade treatment-related adverse
events was similar between arms. The most common AE’s occurring in more than 20% of patients receiving
Tecentriq plus Avastin and with a greater than 5% increase when compared to sunitinib included: arthralgia
(38%), proteinuria (36%), epistaxis (28%), and pruritus (22%). Frequency of grade 3-4 AEs regardless of
relationship to treatment were similar between patients treated with TECENTRIQ plus Avastin (63%) and
sunitinib (69%). Treatment-related grade 3-4 events reported in 40% of TECENTRIQ plus Avastin treated
patients and 57% of sunitinib treated patients. One person who was treated with TECENTRIQ plus Avastin
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experienced intracranial haemorrhage that led to death. Fifteen of 101 patients (15%) treated with
TECENTRIQ plus Avastin discontinued treatment for adverse events.
About renal cell carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer and forms when abnormal cells
develop in the small tubes (known as renal tubules) in the kidneys. Each year about 338,000 people are
diagnosed with kidney cancer globally accounting for nearly 145,000 deaths worldwide.1 The disease is more
prevalent in males and people aged 55–74 years.2 Currently there is a significant need for more effective
treatments with only about one in ten people alive five years post diagnosis.2
About TECENTRIQ® (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed
death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts
with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this
interaction, TECENTRIQ may enable the activation of T cells, restoring their ability to effectively detect and
attack tumour cells.
About Avastin
With the initial approval for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic
therapy made widely available for the treatment of patients with an advanced cancer. Today, Avastin is
continuing to transform cancer care across the world through its proven survival benefit (overall survival
and/or progression free survival) in several types of cancer, including colorectal cancer, non-small cell lung
cancer, kidney cancer, breast cancer, ovarian cancer, cervical cancer, and glioblastoma. Avastin has made
anti-angiogenic therapy a fundamental pillar of cancer treatment today with over 2.4 million patients treated
with this medicine so far. With one of the largest clinical development programmes ever seen in oncology,
Avastin will continue to transform how patients are treated as ongoing studies seek to understand the full
potential of this medicine and its combinations with the most cutting edge therapies in development.
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.
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About personalised cancer immunotherapy (PCI)
The aim of personalised cancer immunotherapy (PCI) is to provide patients and physicians with treatment
options tailored to the specific immune biology associated with a person’s individual tumour. The purpose is
to inform treatment strategies which provide the greatest number of people with a chance for transformative
benefit. In the case of TECENTRIQ, the goal of PD-L1 as a biomarker is to explore PD-L1 expression on
tumour cells and tumour infiltrating immune cells and how that correlates with clinical benefit either as a
monotherapy or in combination, and across a broad range of tumour types. The Roche PCI research and
development programme comprises more than 20 investigational candidates, ten of which are in clinical
trials.
PCI is an essential component of how Roche delivers on the broader commitment to personalised healthcare.
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/cancerimmunotherapy.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 for improving patient access to medical
innovations by working with all relevant stakeholders. Twenty-nine 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. Roche has been recognised as the Group Leader in
sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the
Dow Jones Sustainability Indices (DJSI).
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed
more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of
CHF 50.6 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.
Roche Group Media Relations
Phone: +41 -61 688 8888 / e-mail: [email protected]
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
References
1. World Health Organization. GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide. Available at:
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Last accessed January 2017.
2. SEER. Stat Fact Sheets: Kidney and Renal Pelvis Cancer. Available at: https://seer.cancer.gov/statfacts/html/kidrp.html Last
accessed January 2017.
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