Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs
2022年11月3日 - 10:00PM
Roche to present data at ASH 2022 showcasing strength of
haematology portfolio and expanding into new areas to address more
patient needs
- Interim data from phase III
HAVEN 7 study reinforce Hemlibra’s
efficacy and safety in infants with severe
haemophilia A without factor VIII
inhibitors1
- New and updated data
support use of Polivy in diffuse
large B-cell lymphoma, including its potential as a treatment
option for previously untreated
patients2
- New and updated data for
innovative CD20xCD3 T-cell engaging bispecific antibodies
Lunsumio and
glofitamab further enhance their potential
as effective, off-the-shelf, fixed-duration treatment options for
people with lymphoma3,4,5,6,7
- First phase III data
for crovalimab show the
co-primary efficacy endpoints were met, with subcutaneous
injections achieving disease control in people with paroxysmal
nocturnal haemoglobinuria as
shown in COMMODORE 3 study in China8
Basel, 3 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced that it will present new data from its
industry-leading haematology portfolio at the 64th American Society
of Hematology (ASH) Annual Meeting from 10-13 December 2022. The
data to be presented span numerous blood diseases, including
haemophilia A, paroxysmal nocturnal haemoglobinuria (PNH), and
various types of blood cancers, including non-Hodgkin lymphoma
(NHL) and multiple myeloma. Roche’s approved and investigational
medicines will be featured in more than 50 abstracts, including
more than 15 oral presentations.
“We continually strive to improve patient outcomes by exploring
new treatment options across blood disorders, such as lymphomas and
rare blood diseases, where unmet needs remain high,” said Levi
Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global
Product Development. “The data we are presenting reinforce our
ongoing commitment to redefining treatment paradigms, improving on
existing standards of care and addressing a diversity of patient
and healthcare system needs.”
Roche’s continued commitment to reinforcing strength of
current portfolioWith 25 years of expertise in blood
diseases, Roche has developed new medicines that changed the
standard of care in several blood disorders with high unmet need.
The data at this year’s meeting exemplify Roche’s commitment
to investing in its current portfolio to further improve patient
outcomes.
- Interim data from the phase III HAVEN 7 study reinforce the
efficacy and safety of Hemlibra® (emicizumab) in infants with
severe haemophilia A without factor VIII inhibitors.1 For this
population, early prophylaxis may prevent long-term damage to
joints and muscles and potentially reduce the risk of intracranial
haemorrhage, which can be life-threatening.9
- New data evaluating Polivy® (polatuzumab vedotin) that
underscore the potential impact of this treatment for the diffuse
large B-cell lymphoma (DLBCL) patient community will be shared at
the meeting. Health-related quality of life (HRQoL) data from the
phase III POLARIX study will be presented, highlighting the
potential impact of Polivy in combination with MabThera®/Rituxan®
(rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP)
on reducing the need for subsequent treatments in people with
previously untreated DLBCL, a population where multiple subsequent
treatments can be a significant treatment burden.2 Based on data
from the POLARIX study, this Polivy combination has been approved
in the EU and recently, Japan, for the treatment of adult patients
with previously untreated DLBCL.
- Roche is presenting updated data from the broadest and most
comprehensive CD20xCD3 bispecific antibody development programme in
the industry. This aims to provide off-the-shelf, fixed-duration
treatment options, which address the unique and diverse needs of
people with blood cancers. Data include updated analyses for
Lunsumio® (mosunetuzumab), the first CD20xCD3 T-cell engaging
bispecific antibody approved by the European Commission to treat
follicular lymphoma (FL), and glofitamab, for which data have been
submitted for approval to the European Medicines Agency, and
submissions to additional health authorities worldwide, including
the U.S. Food and Drug Administration (FDA), are ongoing.
- An updated analysis from the pivotal phase II GO29781 study of
Lunsumio in people with relapsed or refractory (R/R) FL after two
or more prior therapies will show continued durable responses
across multiple key efficacy endpoints in addition to offering the
potential to be administered in an outpatient setting.3 In
addition, studies evaluating Lunsumio as a monotherapy and in novel
combinations for the treatment of DLBCL in earlier lines of
treatment will be presented, highlighting the potential of Lunsumio
in other settings.4,5
- Updated results from the phase II NP30179 study will show a
fixed course of glofitamab monotherapy can deliver durable complete
responses in people with heavily pre-treated aggressive
lymphomas.6,7 Results from the pivotal R/R DLBCL cohort indicate
patients can maintain durable responses following fixed-duration
treatment with glofitamab, potentially allowing them to benefit
from a treatment-free period.6
Exploring and innovating in new areas of unmet
needRoche is applying its scientific expertise to expand
its haematology clinical development programme by exploring
additional blood diseases and bringing innovations that address the
various needs of patients in areas of high unmet need.
- The first phase III clinical data for crovalimab from the
COMMODORE 3 study in China, will be presented at ASH. These data
demonstrate that crovalimab met the co-primary efficacy endpoints,
suggesting that crovalimab is efficacious and well-tolerated in
people with PNH, a rare and life-threatening blood condition, where
healthy red blood cells are targeted and destroyed by the body’s
complement system.8 There are currently no effective treatment
options for PNH broadly available in China.
- Spark Therapeutics, a member of the Roche Group, will share
updated long-term follow-up data from the ongoing phase I/II
clinical trial of SPK-8011, an investigational AAV-based gene
therapy being developed for the treatment of haemophilia A.10 The
acquisition of Spark Therapeutics brought new capabilities in
haemophilia A to address the high unmet medical need for people
living with this disease and endeavour to create additional benefit
beyond current treatment options.
- Positive data on cevostamab will be
presented at ASH, including data from the phase I GO39775 study,
which suggest that patients with heavily pre-treated multiple
myeloma can maintain durable responses with fixed-duration
cevostamab.11 Additionally, phase I data from Roche’s GPRC5DxCD3
T-cell engaging bispecific antibody, RG6234, showing encouraging
preliminary activity in people with R/R multiple myeloma, will be
presented.12 With this pipeline, Roche is committed to advancing
treatments for multiple myeloma, which remains an incurable disease
characterised by multiple relapses.
Further information on the key abstracts featuring Roche
medicines that will be presented at ASH can be found in the table
below.Follow Roche on Twitter via @Roche and on LinkedIn and keep
up to date with ASH Annual Meeting news and updates by using the
hashtag #ASH22.
Medicine |
Abstract title |
Abstract number/presentation details |
Cevostamab |
Pre-treatment with Tocilizumab Prior to the CD3 Bispecific
Cevostamab in Patients with Relapsed/Refractory Multiple Myeloma
(RRMM) Showed a Marked Reduction in Cytokine Release Syndrome
Incidence and Severity |
#567 poster presentationSession: 653Sunday, 11 December 2022
12:00-13:30 CT/19:00-20:30 CET |
Enduring Responses After One-Year, Fixed-Duration Cevostamab
Therapy in Patients with Relapsed/Refractory Multiple Myeloma:
Early Experience from a Phase I Study |
#1924 poster presentationSession: 653Saturday, 10 December 2022
17:30-19:30 CT/00:30-2:30 CET [+1 day] |
Crovalimab |
Results From the First Phase 3 Crovalimab (C5-Inhibitor) Study
(COMMODORE 3): Efficacy and Safety in Complement Inhibitor-Naive
Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) |
#293 oral presentationSession: 508Saturday, 10 December 2022
16:00-17:30 CT/23:00-00:30 CET |
Pharmacokinetic Characterization and Exposure-Response Relationship
of Crovalimab in the COMPOSER and COMMODORE 3 Trials of Patients
with Paroxysmal Nocturnal Hemoglobinuria (PNH) |
#1247 poster presentationSession: 508Saturday, 10 December 2022
17:30-19:30 CT/00:30-02:30 CET [+1 day] |
Glofitamab |
Glofitamab Monotherapy Induces High Complete Response Rates in
Patients with Heavily Pre-treated Relapsed or Refractory Mantle
Cell Lymphoma |
#74 oral presentationSession: 623Saturday, 10 December 2022
09:30-11:00 CT/16:30-18:00 CET |
Relapse is Uncommon in Patients with Large B-Cell Lymphoma Who Are
in Complete Remission at the End of Fixed-Course Glofitamab
Treatment |
#441 oral presentationSession: 626Sunday, 11 December 2022
09:30-11:00 CT/16:30-18:00 CET |
Glofitamab Plus R-CHOP Induces High Response Rates and a Favorable
Safety Profile in Patients with Previously Untreated Diffuse Large
B-Cell Lymphoma (DLBCL): Results from a Phase Ib Study |
#737 oral presentationSession: 626Monday, 12 December
202210:30-12:00 CT/19:00-20:30 CET |
Hemlibra |
Emicizumab Prophylaxis for the Treatment of Infants with Severe
Hemophilia A without Factor VIII Inhibitors: Results from the
Interim Analysis of the HAVEN 7 Study |
#187 oral presentationSession: 322Saturday, 10 December
202214:00-15:30 CT/21:00-22:30 CET |
Real-World Safety of Emicizumab: Interim Analysis of the European
Haemophilia Safety Surveillance (EUHASS) Database |
#192 oral presentationSession: 322Saturday, 10 December
202214:00-15:30 CT/21:00-22:30 CET |
Characteristics and Bleeding Behavior of Females with Mild
Hemophilia A: Longitudinal Study from PicnicHealth Hemophilia A
Database |
#27 oral presentationSession: 322Saturday, 10 December
202209:30-11:00 CT/16:00-18:00 CET |
Emicizumab and Females with Hemophilia A: Case Series from ATHN
7 |
#1162 poster presentationSession: 322Saturday, 10 December
202217:30-19:30 CT/00:30-02:30 CET [+1 day] |
Characteristics and Healthcare Utilization of Patients with Mild or
Moderate Hemophilia A in the US - An Analysis from the PicnicHealth
Cohort |
#1170 poster presentationSession: 322Saturday, 10 December
202217:30-19:30 CT/00:30-02:30 CET [+1 day] |
Lunsumio |
Mosunetuzumab Monotherapy Demonstrates Durable Efficacy with a
Manageable Safety Profile in Patients with Relapsed/Refractory
Follicular Lymphoma who have Received ≥2 Prior Therapies: Updated
Results from a Pivotal Phase II Study |
#610 oral presentationSession: 623Sunday, 11 December
202216:30-18:00 CT/23:30-01:00 CET |
Mosunetuzumab Monotherapy Continues to Demonstrate Promising
Efficacy and Durable Complete Responses in Elderly/Unfit Patients
with Previously Untreated Diffuse Large B-cell Lymphoma |
#738 oral presentationSession: 626Monday, 12 December
202210:30-12:00 CT/17:30-19:00 CET |
Mosunetuzumab with Polatuzumab Vedotin is Effective and has a
Manageable Safety Profile in Patients Aged <65 and ≥65 Years
with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
and ≥1 Prior Therapy: Subgroup Analysis of a Phase Ib/II Study |
#1630 poster presentationSession: 626Saturday, 10 December
202217:30-19:30 CT/00:30-02:30 CET [+1 day] |
SUNMO: A Phase III Trial Evaluating the Efficacy and Safety of
Mosunetuzumab in Combination with Polatuzumab Vedotin versus
Rituximab in Combination with Gemcitabine plus Oxaliplatin in
Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin
Lymphoma |
#1637 poster presentationSession: 626Saturday, 10 December
202217:30-19:30 CT/00:30-02:30 CET [+1 day] |
Subcutaneous (SC) Mosunetuzumab is Active with a Manageable Safety
Profile in Patients with Relapsed/Refractory (R/R) B-cell
non-Hodgkin Lymphoma (B-NHL): Updated Results from a Phase I/II
Study |
#1628 poster presentationSession: 626Saturday, 10 December
202217:30-19:30 CT/00:30-02:30 CET [+1 day] |
Polivy |
Risk Profiling of Patients with Previously Untreated Diffuse Large
B-Cell Lymphoma (DLBCL) by Measuring Circulating Tumor DNA (ctDNA):
Results from the POLARIX Study |
#542 oral presentationSession: 621Sunday, 11 December
202212:00-13:30 CT/19:00-20:30 CET |
Polatuzumab Vedotin plus Bendamustine and Rituximab in
Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL):
Final Results of a Phase Ib/II Randomized Study and Single-Arm
Extension (Ext) Study |
#4260 poster presentationSession: 626Monday, 12 December
202218:00-20:00 CT/01:00-03:00 CET [+1 day] |
Total Cost of Care in Relapsed/Refractory (R/R) Diffuse Large
B-cell Lymphoma (DLBCL) |
#3527 poster presentationSession: 902Sunday, 11 December
202218:00-20:00 CT/01:00-03:00 CET [+1 day] |
Health-Related Quality of Life (HRQoL) in Patients with Diffuse
Large B-Cell Lymphoma (DLBCL) Treated with Polatuzumab Vedotin,
Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
(Pola-R-CHP) versus Rituximab, Cyclophosphamide, Doxorubicin,
Vincristine and Prednisone (R-CHOP) in the Phase III POLARIX
Study |
#2949 poster presentationSession: 626Sunday, 11 December
202218:00-20:00 CT/01:00-03:00 CET [+1 day] |
RG6234 |
RG6234, a GPRC5DxCD3 T-cell Engaging Bispecific Antibody, is Highly
Active in Patients (pts) with Relapsed/Refractory Multiple Myeloma
(RRMM): Updated Intravenous (IV) and First Subcutaneous (SC)
Results from a Phase I Dose-Escalation study |
#161 oral presentationSession: 653Saturday, 10 December
202212:00-13:30 CT/19:00-20:30 CET |
SPK-8011 |
Long-Term Durable FVIII Expression with Improvements in Bleeding
Rates Following AAV-Mediated FVIII Gene Transfer for Hemophilia A:
Multiyear Follow-up on the Phase I/II Trial of SPK-8011 |
#783 oral presentationSession: 801Monday, 12 December
202210:30-12:00 CT/17:30-19:00 CET |
Rapid Clearance of Vector Following AAV-Mediated FVIII Gene
Transfer in the Phase I/II Trial of SPK-8011 in People with
Hemophilia A |
#4783 poster presentationSession: 801Monday, 12 December
202218:00-20:00 CT/01:00-03:00 CET [+1 day] |
The Effects of Immunomodulation with Corticosteroids to Manage an
AAV Capsid Immune response in the Phase I/II Study of SPK-8011 |
#4779 poster presentationSession: 801Monday, 12 December
202218:00-20:00 CT/01:00-03:00 CET [+1 day] |
About Roche
in haematologyRoche has been
developing medicines for people with malignant and non-malignant
blood diseases for more than 20 years; our experience and knowledge
in this therapeutic area runs deep. Today, we are investing more
than ever in our effort to bring innovative treatment options to
patients across a wide range of haematologic diseases. Our approved
medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro®
(obinutuzumab), Polivy® (polatuzumab vedotin),
Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie,
Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab). Our pipeline
of investigational haematology medicines includes T-cell engaging
bispecific antibodies glofitamab, targeting both CD20 and CD3 and
cevostamab, targeting both FcRH5 and CD3, Tecentriq®
(atezolizumab), a monoclonal antibody designed to bind with PD-L1,
and crovalimab, an anti-C5 antibody engineered to optimise
complement inhibition. Our scientific expertise, combined with the
breadth of our portfolio and pipeline, also provides a unique
opportunity to develop combination regimens that aim to improve the
lives of patients even further.
About Roche and Spark Therapeutics gene therapy research
in haemophilia AWe
believe gene therapy has the potential to revolutionise medicine
and improve the lives of patients with genetic and other serious
diseases. Pairing Roche’s long-standing commitment to developing
medicines in haemophilia with Spark Therapeutics’ proven gene
therapy expertise brings together the best team of collaborators
researching gene therapies in haemophilia A.
It is our aligned objective to develop gene therapies for
haemophilia A that, with the lowest effective dose and the optimal
immunomodulatory regimen, demonstrate safety, predictability,
efficacy, and durability for patients.About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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] Pipe S, et al. Emicizumab
Prophylaxis for the Treatment of Infants with Severe Hemophilia A
without Factor VIII Inhibitors: Results from the Interim Analysis
of the HAVEN 7 Study. Presentation at: ASH Annual Meeting and
Exposition; 2022 Dec 10-13 Abstract #187.[2] Friedberg JW, et al.
Health-Related Quality of Life (HRQoL) in Patients with Diffuse
Large B-Cell Lymphoma (DLBCL) Treated with Polatuzumab Vedotin,
Rituximab, Cyclophosphamide, Doxorubicin and Prednisone (Pola-RCHP)
versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and
Prednisone (R-CHOP) in the Phase III POLARIX Study. Presentation
at: ASH Annual Meeting and Exposition; 2022 Dec 10-13 Abstract
#2949.[3] Bartlett NL, et al. Mosunetuzumab Monotherapy
Demonstrates Durable Efficacy with a Manageable Safety Profile in
Patients with Relapsed/Refractory Follicular Lymphoma Who Received
≥2 Prior Therapies: Updated Results from a Pivotal Phase II Study.
Presentation at: ASH Annual Meeting and Exposition; 2022 Dec 10-13
Abstract #610.[4] Olszewski AJ, et al. Mosunetuzumab Monotherapy
Continues to Demonstrate Promising Efficacy and DurableComplete
Responses in Elderly/Unfit Patients with Previously Untreated
Diffuse Large B-cellLymphoma. Presentation at: ASH Annual Meeting
and Exposition; 2022 Dec 10-13 Abstract #738.[5] Olszewski AJ, et
al. Mosunetuzumab with Polatuzumab Vedotin is Effective and has a
Manageable Safety Profile in Patients Aged <65 and ≥65 Years
with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/RDLBCL)
and ≥1 Prior Therapy: Subgroup Analysis of a Phase Ib/II Study.
Presentation at: ASH Annual Meeting and Exposition; 2022 Dec 10-13
Abstract #1630.[6] Hutchings M, et al. Relapse is Uncommon in
Patients with Large B-Cell Lymphoma Who Are in Complete Remission
at the End of Fixed-Course Glofitamab Treatment. Presentation at:
ASH Annual Meeting and Exposition; 2022 Dec 10-13 Abstract #441.[7]
Phillips T, et al. Glofitamab Monotherapy Induces High Complete
Response Rates in Patients with Heavily Pre-treated Relapsed or
Refractory Mantle Cell Lymphoma. Presentation at: ASH Annual
Meeting and Exposition; 2022 Dec 10-13 Abstract #74.[8] Liu H, et
al. Results From the First Phase 3 Crovalimab (C5-Inhibitor) Study
(COMMODORE 3): Efficacy and Safety in Complement Inhibitor-Naive
Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
Presentation at: ASH Annual Meeting and Exposition; 2022 Dec 10-13
Abstract #293.[9] Srivastava A, et al. WFH guidelines for the
management of hemophilia, 3rd edition. Haemophilia. 2020; 26 (Suppl
6): 1-158.[10] Croteau SE, et al. Long-Term Durable FVIII
Expression with Improvements in Bleeding Rates Following
AAV-Mediated FVIII Gene Transfer for Hemophilia A: Multiyear
Follow-up on the Phase I/II Trial of SPK-8011. Presentation at: ASH
Annual Meeting and Exposition; 2022 Dec 10-13 Abstract #783.[11]
Lesokhin A, et al. Enduring Responses After 1-Year, Fixed-Duration
Cevostamab Therapy in Patients with Relapsed/Refractory Multiple
Myeloma: Early Experience from a Phase I Study. Presentation at:
ASH Annual Meeting and Exposition; 2022 Dec 10-13 Abstract
#1924.[12] Carlo-Stella C, et al. RG6234, a GPRC5DxCD3 T-cell
engaging bispecific antibody, is highly active in patients (pts)
with relapsed/refractory multiple myeloma (RRMM): updated
intravenous (IV) and first subcutaneous (SC) results from a Phase I
dose-escalation study. Presentation at: ASH Annual Meeting and
Exposition; 2022 Dec 10-13 Abstract #161.
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