Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024
05 Novembro 2024 - 11:15AM
UK Regulatory
Roche to present new and encouraging long-term follow-up data
across broad haematology portfolio at ASH 2024
Basel, 05 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that it will present more than 40 abstracts across
nine blood disorders at the 66th American Society of
Hematology (ASH) Annual Meeting and Exposition, held 7-10 December
2024 in San Diego, US. The data underscore Roche’s commitment to
advance patient outcomes in lymphoma with long-term follow-up of
its approved medicines Polivy® (polatuzumab vedotin), Lunsumio®
(mosunetuzumab) and Columvi® (glofitamab) as well as new
investigational combination data.
Key presentations include:
- Five-year data from the phase III POLARIX study (abstract #469)
reinforce the potential of Polivy in combination with
MabThera®/Rituxan® (rituximab), cyclophosphamide,
doxorubicin and prednisone (R-CHP) to provide durable and lasting
remissions and for the first time show a positive trend in overall
survival (OS) for people with first-line diffuse large B-cell
lymphoma (DLBCL), an area that previously had little advancement in
nearly two decades.1
- Extended follow-up data of up to four years from the pivotal
GO29781 study of Lunsumio (abstract #4407) and NP30179 study of
Columvi (abstract #865) show long-lasting remissions and immune
system recovery after the end of treatment, supporting the use of
fixed-duration bispecific antibodies for third line or later (3L+)
follicular lymphoma (FL) and DLBCL respectively.2,3
- First presentation of data for a subcutaneous formulation of
Lunsumio monotherapy from the pivotal phase II GO29781 study
(abstract #1645) show high rates of deep and durable responses and
low rates and severity of cytokine release syndrome in people with
3L+ FL.4 Subcutaneously administered Lunsumio could
further improve the patient experience by combining shorter
administration time with the existing benefits of a fixed-duration
and outpatient therapy.
- New patient-reported outcomes data from the phase III STARGLO
study (abstract #5132) indicate comparable health-related quality
of life between treatment arms, despite higher median number of
cycles received with the Columvi combination (11 versus
4).5 Together with the significant improvement in OS
observed in the study, these data support the potential benefit for
patients with second-line or later DLBCL.
- New and updated data from investigational study combinations of
Polivy with bispecific antibodies Lunsumio and Columvi in relapsed
or refractory DLBCL, including the phase Ib/II NP39488 (abstract
#988) and phase II GO40516 (abstract #989) studies, add to the
growing body of evidence demonstrating the potential of novel
bispecific antibody/Polivy combinations in earlier treatment lines,
and support their ongoing phase III development.6,7
Overview of key presentations featuring Roche
medicines
Medicine |
Abstract title |
Abstract number/presentation details |
Polivy® (polatuzumab vedotin)
|
Five-Year Analysis of the POLARIX Study: Prolonged Follow-up
Confirms Positive Impact of Polatuzumab Vedotin Plus Rituximab,
Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) on
Outcomes |
#469 oral presentation
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological:
CARs, Bispecifics, and ADCs: Progress and Challenges in Aggressive
B Cell Lymphoma
Sunday 8 December 2024
9.30am PST |
A Multicenter, Prospective, Observational Study of Pola-R-CHP in
Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
(POLASTAR): A Preliminary Analysis |
#4475 poster presentation
Session: 626. Aggressive Lymphomas: Clinical and Epidemiological:
Poster III
Monday 9 December 2024
6pm-8pm PST |
Lunsumio® (mosunetuzumab)
|
A Randomized Phase II Study of Mosunetuzumab SC Plus Polatuzumab
Vedotin Demonstrates Improved Outcomes Versus Rituximab Plus
Polatuzumab Vedotin in Patients (Pts) with Relapsed or Refractory
(R/R) Large B-Cell Lymphoma (LBCL) |
#989 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies:
Chemotherapy-free Combinations for Relapsed Aggressive
Lymphomas
Monday 9 December 2024
5.30pm PST |
Subcutaneous Mosunetuzumab Leads to High Rates of Durable
Responses, Low Rates of Cytokine Release Syndrome, and Non-Inferior
Exposure Compared with Intravenous Administration in Patients with
Relapsed/Refractory Follicular Lymphoma: Primary Analysis of a
Pivotal Phase II Study |
#1645 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
I
Saturday 7 December 2024
5.30pm-7.30pm PST |
Mosunetuzumab Continues to Demonstrate Clinically Meaningful
Outcomes in Patients with Relapsed and/or Refractory Follicular
Lymphoma after ≥2 Prior Therapies Including Those with a History of
POD24: 4-Year Follow-up of a Pivotal Phase II Study |
#4407 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
III
Monday 9 December 2024
6pm-8pm PST |
Mosunetuzumab Monotherapy Demonstrates Encouraging Activity and a
Manageable Safety Profile in Patients with Heavily Pre-Treated
Relapsed or Refractory Mantle Cell Lymphoma |
#1646 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
I
Saturday 7 December 2024
5.30pm-7.30pm PST |
Fixed-Duration Subcutaneous Mosunetuzumab is Active and has a
Manageable Safety Profile in Patients with Previously Untreated,
Low-Tumor Burden Follicular Lymphoma: Updated Results from the
Phase II MorningSun Study |
#3008 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
II
Sunday 8 December 2024
6pm-8pm PST |
Travel Burden and Travel Costs of Bispecific Antibodies in Patients
with Relapsed/Refractory Diffuse Large B-Cell Lymphoma and
Relapsed/Refractory Follicular Lymphoma |
#782 oral presentation
Session: 902. Health Services and Quality Improvement: Lymphoid
Malignancies: For a Better Tomorrow - Improving Access to Blood
Cancer Treatments and Trials
Monday 9 December 2024
10.45am PST |
Columvi® (glofitamab)
|
Fixed-duration Glofitamab Monotherapy Continues to Demonstrate
Durable Responses in Patients with Relapsed or Refractory Large
B-Cell Lymphoma: 3-year Follow-Up From a Pivotal
Phase II Study |
#865 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: New
R-CHOP Combinations for Treatment Naïve DLBCL
Sunday 8 December 2024
Midday PST |
Glofitamab in Combination with Polatuzumab Vedotin Maintains
Durable Responses and a Manageable Safety Profile in Patients with
Heavily Pre-treated Relapsed/Refractory (R/R) Large B-Cell Lymphoma
(LBCL) Including High-Grade B-Cell Lymphoma (HGBCL): Extended
Follow-Up of a Phase Ib/II Study |
#988 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies:
Chemotherapy-free Combinations for Relapsed Aggressive
Lymphomas
Monday 9 December 2024
5.15pm PST |
Glofitamab in Combination with Rituximab plus Ifosfamide,
Carboplatin, and Etoposide shows Favorable Efficacy and Manageable
Safety in Patients with Relapsed or Refractory Diffuse Large B-cell
Lymphoma, Eligible for Stem Cell Transplant or Chimeric Antigen
Receptor T-cell Therapy: Results from a Phase Ib Study |
#987 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies:
Chemotherapy-free Combinations for Relapsed Aggressive
Lymphomas
Monday 9 December 2024
5pm PST |
Primary Results of Patient-Reported Outcomes in Patients with
Relapsed/Refractory Diffuse Large
B-cell Lymphoma Treated with Glofitamab plus Gemcitabine and
Oxaliplatin (Glofit-GemOx) Versus Rituximab plus GemOx (R-GemOx)
from the Phase III STARGLO Study |
#5132 poster presentation
Session: 906. Outcomes Research: Lymphoid Malignancies Excluding
Plasma Cell Disorders: Poster III
Monday 9 December 2024
6pm-8pm PST |
Glofitamab Induces High Response Rates and Durable Remissions in
Patients (Pts) with Heavily Pretreated Relapsed/Refractory (R/R)
Mantle Cell Lymphoma (MCL), including those with a Poor Prognosis:
Subgroup Results from a Phase I/II Study |
#1631 poster presentation
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
I
Saturday 7 December 2024
5.30pm-7.30pm PST |
A Healthcare Utilization Model Comparing Time Toxicity Between
Glofitamab and Epcoritamab Treatment Regimens |
#3647 poster presentation
Session: 902. Health Services and Quality Improvement: Lymphoid
Malignancies: Poster II
Sunday 8 December 2024
6pm-8pm PST |
Englumafusp alfa |
Englumafusp alfa (CD19-4-1BBL) combined with glofitamab is safe and
efficacious in patients with r/r B-NHL: extended follow up analysis
of the dose-escalation part of Phase 1 trial BP41072 |
#990 oral presentation
Session: 627. Aggressive Lymphomas: Pharmacologic Therapies:
Chemotherapy-free Combinations for Relapsed Aggressive
Lymphomas
Monday 9 December 2024
5.45pm PST |
Cevostamab |
Cevostamab in Patients with Heavily Pretreated Relapsed/Refractory
Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I
Study Demonstrate Clinically Meaningful Activity and Manageable
Safety and Inform the Doses and Regimen for Combination
Studies |
#1021 oral presentation
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Into the
Future: New Drugs and Combinations in Multiple Myeloma
Monday 9 December 2024
4.30pm PST |
Venclexta®/Venclyxto® (venetoclax)* |
CRISTALLO: Results from a Phase III Trial of
Venetoclax–Obinutuzumab versus Fludarabine, Cyclophosphamide and
Rituximab or Bendamustine–Rituximab in Patients with Untreated
Chronic Lymphocytic Leukemia Without Del(17p) or TP53
Mutations |
#3237 poster presentation
Session: 642. Chronic Lymphocytic Leukemia: Clinical and
Epidemiological: Poster II
Sunday 8 December 2024
6pm-8pm PST |
P-CD19CD20-ALLO1
(in collaboration with Poseida Therapeutics) |
P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting
CD19 and CD20 with Superior Efficacy Over Single-Target
Products |
#4805 poster presentation
Session: 702. CAR-T Cell Therapies: Basic and Translational: Poster
III
Monday 9 December 2024
6pm-8pm PST |
P-BCMA-ALLO1 (in collaboration with Poseida Therapeutics) |
A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA
Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM):
Results from Optimized Lymphodepletion Cohort |
#4828 poster presentation
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials
and Toxicities: Poster III
Monday 9 December 2024
6pm-8pm PST |
Hemlibra® (emicizumab)
|
Bleed Patterns in Infants, From Birth to 12 Months of Age, with
Hemophilia A Treated with Emicizumab: Exploratory Analysis of the
HAVEN 7 Study |
#1214 poster presentation
Session: 322. Hemophilia A and B: Clinical and Epidemiological:
Poster I
Saturday 7 December 2024
5.30pm-7.30pm PST |
Real-World Experience With Emicizumab for Hemophilia A From the
Physician Perspective Based on Survey Data |
#5078 poster presentation
Session: 905. Outcomes Research: Non-Malignant Conditions Excluding
Hemoglobinopathies: Poster III
Monday 9 December 2024
6pm-8pm PST |
PiaSky® (crovalimab)
|
Phase III Randomized COMMODORE 2 Trial: 2-Year Efficacy and Safety
of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria
(PNH) Naive to Complement Inhibition |
#2687 poster presentation
Session: 508. Bone Marrow Failure: Acquired: Poster II
Sunday 8 December 2024
6pm-8pm PST |
Phase III COMMODORE 1 Trial: 2-Year Efficacy and Safety of
Crovalimab in Patients with Paroxysmal Nocturnal Hemoglobinuria
(PNH) Who Switched from Ravulizumab |
#4078 poster presentation
Session: 508. Bone Marrow Failure: Acquired: Poster III
Monday 9 December 2024
6pm-8pm PST |
*Venclexta/Venclyxto 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.
About Roche in haematology
Roche has been developing medicines for people with malignant and
non-malignant blood diseases for more than 25 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), PiaSky® (crovalimab), Lunsumio®
(mosunetuzumab) and Columvi® (glofitamab). Our pipeline of
investigational haematology medicines includes T-cell engaging
bispecific antibody cevostamab, targeting both FcRH5 and CD3 and
Tecentriq® (atezolizumab). 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
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.
For over 125 years, sustainability has been an integral part of
Roche’s business. As a science-driven company, our greatest
contribution to society is developing innovative medicines and
diagnostics that help people live healthier lives. Roche is
committed to the Science Based Targets initiative and the
Sustainable Markets Initiative to achieve net zero by 2045.
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] Salles G, et al. Five-Year Analysis of the POLARIX Study:
Prolonged Follow-up Confirms Positive Impact of Polatuzumab Vedotin
Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone
(Pola-R-CHP) on Outcomes. Presented at: ASH Annual Meeting; 2024
Dec 7-10; San Diego, CA, USA. Abstract #469.
[2] Shadman M, et al. Mosunetuzumab Continues to Demonstrate
Clinically Meaningful Outcomes in Patients with Relapsed and/or
Refractory Follicular Lymphoma after ≥2 Prior Therapies Including
Those with a History of POD24: 4-Year Follow-up of a Pivotal Phase
II Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10; San
Diego, CA, USA. Abstract #4407.
[3] Dickinson M, et al. Fixed-duration Glofitamab Monotherapy
Continues to Demonstrate Durable Responses in Patients with
Relapsed or Refractory Large B-Cell Lymphoma: 3-year Follow-Up From
a Pivotal Phase II Study. Presented at: ASH Annual Meeting; 2024
Dec 7-10; San Diego, CA, USA. Abstract #865.
[4] Bartlett N, et al. Subcutaneous Mosunetuzumab Leads to High
Rates of Durable Responses, Low Rates of Cytokine Release Syndrome,
and Non-Inferior Exposure Compared with Intravenous Administration
in Patients with Relapsed/Refractory Follicular Lymphoma: Primary
Analysis of a Pivotal Phase II Study. Presented at: ASH Annual
Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract #1645.
[5] Gregory G, et al. Primary Results of Patient-Reported Outcomes
in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma
Treated with Glofitamab plus Gemcitabine and Oxaliplatin
(Glofit-GemOx) Versus Rituximab plus GemOx (R-GemOx) from the Phase
III STARGLO Study. Presented at: ASH Annual Meeting; 2024 Dec 7-10;
San Diego, CA, USA. Abstract #5132.
[6] Hutchings M, et al. Glofitamab in Combination with Polatuzumab
Vedotin Maintains Durable Responses and a Manageable Safety Profile
in Patients with Heavily Pre-treated Relapsed/Refractory (R/R)
Large B-Cell Lymphoma (LBCL) Including High-Grade B-Cell Lymphoma
(HGBCL): Extended Follow-Up of a Phase Ib/II Study. Presented at:
ASH Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract
#988.
[7] Chavez J, et al. A Randomized Phase II Study of Mosunetuzumab
SC Plus Polatuzumab Vedotin Demonstrates Improved Outcomes Versus
Rituximab Plus Polatuzumab Vedotin in Patients (Pts) with Relapsed
or Refractory (R/R) Large B-Cell Lymphoma (LBCL). Presented at: ASH
Annual Meeting; 2024 Dec 7-10; San Diego, CA, USA. Abstract
#989.
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