-
Study results across 17
medicines reflect our commitment to personalised care with advances
in targeted therapies, immunotherapy, and diagnostics, data and
analytics
-
New pivotal data on
fixed-duration combination of Venclexta/Venclyxto plus
Gazyva/Gazyvaro in previously untreated chronic lymphocytic
leukaemia
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New data for entrectinib in
paediatric patients with recurrent or refractory solid tumours
harbouring NTRK, ROS1 or ALK gene fusions
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Key highlights to be shared at
Roche's ASCO Media Briefing on 31 May 2019, from 09:00 - 10:30 CDT
at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL,
US
Basel, 10 May 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that new data from clinical trials of 17
approved and investigational medicines across 27 cancer types,
including hard-to-treat and rare tumours, will be presented at the
2019 American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, IL, United States, from 31 May- 4 June, 2019. A total of
155 abstracts that include a Roche medicine will be presented at
this year's meeting.
"At this year's ASCO meeting, we are excited to present new data
with targeted therapies, immunotherapy and pipeline combinations
across a broad range of diseases including blood, breast and lung
cancers, as well as paediatric tumours treated with our
personalised cancer medicine, entrectinib," said Sandra Horning,
MD, chief medical officer and head of Global Product Development.
"Through pioneering science, strategic partnerships and data and
analytics, we're striving to develop transformative medicines that
can help improve outcomes for each individual patient."
Further information on Roche's contribution to the ASCO 2019
scientific programme, as well as the latest innovations and
developments in Roche's approach to accelerating progress in cancer
care, will be featured during the Roche Media Briefing from 09:00 -
10:30 CDT on Friday 31 May at the Chicago Marriott Downtown
Magnificent Mile, Chicago, IL, US. This event, independently
organised by Roche, is open to journalists from outside the United
States who have registered as media with the ASCO 2019 Annual
Meeting.
To register for the Roche Media Briefing, please follow this link:
http://roche.cvent.com/d/v6qcp1?ct=94fca666-18b0-4c40-b5f7-6b4b845171c7
Keep up to date on ASCO meeting news and updates by following Roche
on Twitter via @Roche and using the hashtag #ASCO19.
Key presentations in blood cancers
The first data from the pivotal Phase III CLL14 study will be
presented at ASCO, evaluating the 12-month, fixed-duration,
chemotherapy-free combination of Venclexta®/Venclyxto® (venetoclax)
plus Gazyva®/Gazyvaro® (obinutuzumab) compared to Gazyva/Gazyvaro
plus chlorambucil in people with previously untreated chronic
lymphocytic leukaemia (CLL) and co-existing medical conditions. The
CLL14 study is being conducted in cooperation with the German CLL
Study Group (GCLLSG), headed by Michael Hallek, MD, University of
Cologne.
The US Food and Drug Administration (FDA) is reviewing a
supplemental New Drug Application (sNDA) based on results of the
CLL14 study under the FDA's Real-Time Oncology Review and
Assessment Aid pilot programmes. Venclexta is being developed by
AbbVie and Roche. It is jointly commercialised by AbbVie and
Genentech, a member of the Roche group, in the US and
commercialised by AbbVie outside of the US.
Key presentations in paediatric
cancers
The first data from the Phase I/II STARTRK-NG study of the
investigational medicine entrectinib in children and adolescents
with recurrent or refractory solid tumours harbouring neurotrophic
tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase
(ALK)-positive tumours, including central nervous system tumours,
will be presented. The study enrolled children and adolescents aged
4.9 months through 20 years (median of seven years) across several
different cancer types, including some rare tumours. The STARTRK-NG
data will be featured as part of ASCO's official press programme on
Wednesday, 15 May.
The FDA recently granted Priority Review for entrectinib for the
treatment of paediatric and adult patients with NTRK
fusion-positive, locally advanced or metastatic solid tumours who
have either progressed following prior therapies or as initial
therapy when there are no acceptable standard therapies, and for
the treatment of people with metastatic, ROS1-positive non-small
cell lung cancer (NSCLC). These NDAs are based on results from the
integrated analysis of the pivotal Phase II STARTRK-2, Phase I
STARTRK-1 and Phase I ALKA-372-001 trials, and data from the
STARTRK-NG study. The FDA is expected to make a decision on the
approval by 18 August 2019.
Key presentations in breast cancers
Key data to be presented at ASCO include updates from Roche's
breast cancer programme across multiple subtypes of the disease,
including the second interim analysis of overall survival (OS)
results, updated safety data and patient-reported outcomes (PROs)
from the Phase III IMpassion130 study of Tecentriq® (atezolizumab)
plus chemotherapy (Abraxane® [paclitaxel protein-bound particles
for injectable suspension (albumin-bound); nab-paclitaxel]) for the
treatment of PD-L1-positive, metastatic triple-negative breast
cancer (TNBC). This combination was recently granted accelerated
approval from the FDA based on progression-free survival (PFS) for
the treatment of adults with unresectable locally advanced or
metastatic TNBC in people whose tumours express PD-L1, as
determined by an FDA-approved test.
Additional data include an eight-year, end-of-study analysis from
the Phase III CLEOPATRA study of Perjeta® (pertuzumab) plus
Herceptin® (trastuzumab) and chemotherapy for first-line treatment
of HER2-positive metastatic breast cancer.
Key presentations in lung cancers
Key data from Roche's broad lung cancer programme will be presented
across different types of the disease, including results from the
Phase III IMpower150 trial of Tecentriq plus Avastin® (bevacizumab)
and chemotherapy (carboplatin and paclitaxel) in chemotherapy-naïve
people previously untreated for metastatic NSCLC whose cancer has
spread to the liver, which affects approximately 20% of people with
the disease. Additionally, results from studies in partnership with
Flatiron Health will be presented, including validation of the use
of next-generation sequencing data on a broad scale to improve the
understanding of clinical outcomes in people with metastatic lung
cancer, and results that illustrate how real-world data can be used
to supplement evidence from clinical trials in rare tumour types
such as ROS1-positive lung cancer.
Key presentations featuring Roche medicines at
ASCO 2019
Medicine |
Abstract title |
Abstract number |
Blood cancer |
Venclexta/Venclyxto
(venetoclax)
Gazyva/Gazyvaro
(obinutuzumab)
|
Effect of fixed-duration venetoclax plus obinutuzumab (VenG)
on progression-free survival (PFS), and rates and duration of
minimal residual disease negativity (MRD-) in previously untreated
patients (pts) with chronic lymphocytic leukemia (CLL) and
comorbidities |
Abstract 7502
(oral)
Tuesday 04 June
10:09 - 10:21 CDT |
Venclexta/Venclyxto
|
Safety and activity of venetoclax in combination with
high-dose cytarabine in children with relapsed or refractory acute
myeloid leukemia |
Abstract 10004
(oral)
Friday 31 May
15:57 - 16:09 CDT |
polatuzumab vedotin
|
Polatuzumab vedotin (Pola) + obinutuzumab (G) and
lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R)
follicular lymphoma (FL): Interim analysis of a Phase Ib/II
trial |
Abstract 7505
(oral)
Tuesday 04 June
11:33 - 11:45 CDT
|
Tumour agnostic |
entrectinib
|
Phase I/II trial to assess the activity of entrectinib in
children and adolescents with recurrent or refractory solid tumors
including central nervous system (CNS) tumors |
Abstract 10009
(oral)
Sunday 02 June
8:00 - 8:12 CDT |
entrectinib
|
Efficacy of entrectinib in patients (pts) with solid tumors
and central nervous system (CNS) metastases: Integrated analysis
from three clinical trials |
Abstract 3017
(poster)
Saturday 01 June
8:00 - 11:00 CDT |
Breast cancer |
Tecentriq
(atezolizumab)
|
IMpassion130: updated overall survival (OS) from a global,
randomized, double-blind, placebo-controlled, Phase III study of
atezolizumab (atezo) + nab-paclitaxel (nP) in
previously untreated locally advanced or metastatic triple-negative
breast cancer (mTNBC) |
Abstract 1003
(oral)
Tuesday 04 June
10:45 - 10:57 CDT |
Perjeta
(pertuzumab)
Kadcyla (ado-trastuzumab emtansine)
Herceptin
(trastuzumab)
|
Neoadjuvant trastuzumab (H), pertuzumab (P), and chemotherapy
versus trastuzumab emtansine (T-DM1) and P in human epidermal
growth factor receptor 2 (HER2)-positive breast cancer (BC): Final
outcome results from the Phase III KRISTINE study |
Abstract 500
(oral)
Monday 03 June
9:45 - 9:57 CDT |
Perjeta
Herceptin
|
Genomic correlates of response to adjuvant trastuzumab (H)
and pertuzumab (P) in HER2+ breast cancer (BC): Biomarker analysis
of the APHINITY trial |
Abstract 1012
(clinical science symposium)
Saturday 01 June
15:48 - 16:00 CDT |
Perjeta
Herceptin
|
End-of-study analysis from the phase III, randomized,
double-blind, placebo (Pla)-controlled CLEOPATRA study of
first-line (1L) pertuzumab (P), trastuzumab (H), and docetaxel (D)
in patients (pts) with HER2-positive metastatic breast cancer
(MBC). |
Abstract 1020 (poster)
Sunday 02 June
8:00 - 11:00 CDT |
Tecentriq
|
IMpassion130: Expanded safety analysis from a P3 study of
atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with
treatment (tx)-naïve, locally advanced or metastatic
triple-negative breast cancer (mTNBC) |
Abstract 1068 (poster)
Sunday 02 June
8:00 - 11:00 CDT |
Tecentriq
|
Patient-reported outcomes (PROs) from the Phase III
IMpassion130 trial of atezolizumab (atezo) plus nabpaclitaxel (nP)
in metastatic triple-negative breast cancer (mTNBC) |
Abstract 1067 (poster)
Sunday 02 June
8:00 - 11:00 CDT |
Kadcyla
Herceptin
|
Patient-reported outcomes (PROs) from KATHERINE: A Phase III
study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab
(H) in patients (pts) with residual invasive disease after
neoadjuvant therapy for HER2-positive breast cancer |
Abstract 513
(poster)
Sunday 02 June
8:00 - 11:00 CDT |
Perjeta
Herceptin |
A phase III, randomized, double-blind, placebo
(Pla)-controlled study of pertuzumab (P) + trastuzumab (H) +
docetaxel (D) versus Pla + H+ D in previously untreated
HER2-positive locally recurrent/metastatic breast cancer (LR/MBC)
(PUFFIN). |
Abstract 1026
(poster)
Sunday 02 June
08:00 - 11:00 CDT
|
Lung cancer |
Tecentriq |
IMpower150: Analysis of efficacy in patients (pts) with liver
metastases (mets) |
Abstract 9012
(poster discussion)
Sunday 02 June
16:30 - 18:00 CDT |
Tecentriq
|
Neoadjuvant atezolizumab in resectable non-small cell lung
cancer (NSCLC): Interim analysis and biomarker data from a
multicenter study (LCMC3) |
Abstract 8503
(oral)
Saturday 01 June 14:15 - 14:27 CDT |
entrectinib
|
Time-to-treatment discontinuation (TTD) and real-world
progression-free survival (rwPFS) as endpoints for comparative
efficacy analysis between entrectinib trial and crizotinib
real-world ROS1 fusion-positive (ROS1+) NSCLC patients |
Abstract 9070
(poster)
Sunday 02 June
8:00 - 11:00 CDT |
Alecensa
(alectinib) |
Final PFS analysis and safety data from the phase III J-ALEX
study of Alectinib(ALC) vs. Crizotinib(CRZ) in ALK-inhibitor naïve
ALK-positive Non-Small Cell Lung Cancer (ALK+NSCLC) |
Abstract: 8569 (poster) Sunday 2 June 8:00 - 11:00
CDT
|
Genitourinary cancers |
Tecentriq |
Clinical outcomes according to PD-L1 status and age in the
prospective international SAUL study of atezolizumab (atezo) for
locally advanced or metastatic urothelial carcinoma (UC) or non-UC
of the urinary tract |
Abstract 4519 (poster)
Monday 03 June
13:15 - 16:15 CDT
|
About Roche in Oncology
Roche has been working to transform cancer care for more than 50
years, bringing the first specifically designed anti-cancer
chemotherapy drug, fluorouracil, to patients in 1962. Roche's
commitment to developing innovative medicines and diagnostics for
cancers remains steadfast.
The Roche Group's portfolio of innovative cancer medicines
includes: Alecensa® (alectinib); Avastin® (bevacizumab); Cotellic®
(cobimetinib); Erivedge® (vismodegib); Gazyva®/Gazyvaro®
(obinutuzumab); Herceptin® (trastuzumab); Kadcyla® (trastuzumab
emtansine); MabThera®/Rituxan® (rituximab); Perjeta® (pertuzumab);
Tarceva® (erlotinib); Tecentriq® (atezolizumab);
Venclexta®/Venclyxto(TM) (venetoclax); Xeloda® (capecitabine);
Zelboraf® (vemurafenib). Furthermore, the Roche Group has a robust
investigational oncology pipeline focusing on new therapeutic
targets and novel combination strategies.
For more information on Roche's approach to cancer,
visit www.roche.com.
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.
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
20190510ASCO Curtain
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