New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma
2023年12月11日 - 3:00PM
New data for Roche’s Columvi and Lunsumio presented at ASH 2023
support continued benefit for people with lymphoma
- Longer-term data from
pivotal studies of fixed-duration Columvi and Lunsumio continue to
show durable responses in people with heavily pre-treated
lymphomas1,2
- New data reinforce the
potential of combination regimens in earlier treatment settings and
add to the robust body of evidence supporting ongoing Phase III
studies3,4,5,6
Basel, 11 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that new data from its CD20xCD3 T-cell engaging
bispecific antibody programme, including eight oral presentations,
were presented at the 65th American Society of Hematology (ASH)
Annual Meeting & Exposition, 9-12 December 2023. Based on
32-month and 3-year follow-ups of two pivotal studies for
fixed-duration treatments of Columvi® (glofitamab) and Lunsumio®
(mosunetuzumab), respectively, data show that remissions were
maintained in the majority of patients with heavily pre-treated
lymphomas.1,2 Additionally, new early-phase data of novel Columvi
or Lunsumio combination regimens support ongoing investigation in
Phase III studies in earlier lines of diffuse large B-cell lymphoma
(DLBCL) and follicular lymphoma (FL).3,4,5,6“Updated data from
pivotal studies of Columvi and Lunsumio continue to provide
compelling evidence for how fixed-duration therapies can deliver
sustained, long-term benefit for people with difficult-to-treat
lymphomas,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “Our data at ASH
also demonstrate progress in evaluating our bispecific antibodies
in earlier stages of disease and additional types of lymphoma so
more people can benefit from our therapies.”Longer
follow-up data from pivotal studies of fixed-duration Columvi and
Lunsumio show benefit is maintained beyond the end of
treatmentExtended follow-up data from the pivotal Phase II
NP30179 study of Columvi administered for up to 12 cycles
(approximately eight months) in patients with relapsed or
refractory (R/R) large B-cell lymphoma (LBCL) who have received at
least two prior lines of therapy showed favourable long-term
outcomes. After a median follow-up of 32 months, 55% of patients
with a complete response (CR) were in remission at 24 months. Most
of these patients remained progression-free and alive 18 months
after completing the fixed-duration treatment. In patients who had
received prior chimeric antigen receptor (CAR) T-cell therapy, the
median duration of CR was 22.0 months (95% confidence interval
[CI]: 6.7–not reached). No new safety signals were observed since
the previous analysis.1Data from a three-year follow-up analysis of
the pivotal Phase II GO29781 study of Lunsumio in patients with R/R
FL who have received at least two prior lines of therapy were
presented. Results showed continued durable responses and a
manageable safety profile after treatment (up to approximately 12
months), with 59% of patients completing treatment after eight
cycles (approximately five months). 72.7% of the patients with a CR
were alive and without disease progression, 30 months after their
first response. In the overall population, median progression-free
survival (PFS) was 24 months (95% CI: 12.0–not evaluable [NE]) and
overall survival (OS) was not yet reached. No new safety signals
were observed since the previous analysis.2Additional data
presented reinforce the potential of novel combination regimens in
earlier treatment settingsDiffuse large B-cell
lymphomaData from the Phase Ib/II GO40516 study of
Lunsumio plus Polivy® (polatuzumab vedotin) in patients with R/R
LBCL were presented and simultaneously published in Nature
Medicine.3,7 Results showed that at 24 months median follow-up, the
median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was
23.3 months (95% CI: 14.8–NE), highlighting the combination’s
potential in R/R LBCL. The overall safety profile of patients with
R/R LBCL treated with Lunsumio plus Polivy was manageable. Cytokine
release syndrome (CRS) events were generally low grade (Grade 1:
10.2%; Grade 2: 5.1%; Grade 3: 3.1%).3 Lunsumio in combination with
Polivy is being evaluated as an outpatient therapy for patients
with R/R DLBCL in the ongoing Phase III SUNMO study.Results from
both arms of the Phase Ib NP40126 study evaluating Columvi in
combination with MabThera®/Rituxan® (rituximab), cyclophosphamide,
doxorubicin, vincristine and prednisone (R-CHOP), and Columvi in
combination with Polivy plus MabThera/Rituxan, cyclophosphamide,
doxorubicin and prednisone (Pola+R-CHP) in previously untreated
DLBCL were presented. After a median of 12 months follow-up, data
from the Columvi plus Pola+R-CHP arm showed that 91.7% of patients
had a CR with no progression observed. Of the patients with a CR,
95.5% were still in remission, with a 12-month PFS rate of 91.5%.
Safety profiles were highly consistent with earlier analyses from
this study.4 These data support the ongoing Phase III SKYGLO study
in previously untreated DLBCL.Follicular
lymphomaThe Phase II MorningSun study, evaluating a
subcutaneous (SC) formulation of Lunsumio in patients with selected
B-cell non-Hodgkin lymphomas, showed that SC Lunsumio is active and
has a manageable safety profile in patients with first-line (1L)
low-tumour burden FL. Data showed that 83.3% of patients achieved a
complete metabolic response (95% CI: 62.6-95.3) and responses were
ongoing at data cut-off. CRS was generally low grade (Grade 1:
36.7%; Grade 2: 6.7%) and occurred in cycle one only.5 Subcutaneous
Lunsumio is also being investigated in combination with oral
lenalidomide in 1L FL in the Phase Ib/II CO41942 study. New data
demonstrated promising efficacy and manageable safety; data showed
that 89.2% of patients achieved a CR and CRS events were either
Grade 1 (47.5%) or 2 (2.5%), all of which were confined to cycles
one to two.6 The data support further investigation of this SC
formulation of Lunsumio and highlight its potential as a tailored
monotherapy or combination outpatient therapy for FL, including in
community practices.5,6Totality of data presented
underscores the strength of Roche's broad, industry-leading
development programme, which aims to address the diverse needs,
preferences and experiences of people with blood
cancersBoth Columvi and Lunsumio are being investigated in
Phase III studies that will expand the understanding of their
impact in earlier lines of treatment. This includes the Phase III
STARGLO study evaluating Columvi in combination with GemOx in
patients with R/R DLBCL who are ineligible for autologous stem cell
transplant; the Phase III SKYGLO study evaluating the efficacy and
safety of Columvi plus Pola+R-CHP in previously untreated DLBCL;
the Phase III GLOBRYTE study evaluating Columvi monotherapy in R/R
mantle cell lymphoma; the Phase III SUNMO study investigating
Lunsumio plus Polivy in R/R DLBCL; and the Phase III CELESTIMO
study investigating Lunsumio plus lenalidomide in patients with R/R
FL.About Columvi® (glofitamab)Columvi is a
CD20xCD3 T-cell engaging bispecific antibody designed to target CD3
on the surface of T-cells and CD20 on the surface of B-cells.
Columvi was designed with a novel 2:1 structural format. This
T-cell engaging bispecific antibody is engineered to have one
region that binds to CD3, a protein on T-cells, a type of immune
cell, and two regions that bind to CD20, a protein on B-cells,
which can be healthy or malignant. This dual-targeting brings the
T-cell in close proximity to the B-cell, activating the release of
cancer cell-killing proteins from the T-cell. A clinical
development programme for Columvi is ongoing, investigating the
molecule as a monotherapy and in combination with other medicines
for the treatment of people with B-cell non-Hodgkin lymphomas,
including diffuse large B-cell lymphoma and other blood
cancers.About Lunsumio® (mosunetuzumab)Lunsumio is
a first-in-class CD20xCD3 T-cell engaging bispecific antibody
designed to target CD3 on the surface of T-cells and CD20 on the
surface of B-cells. This dual-targeting activates and redirects a
patient’s existing T-cells to engage and eliminate target B-cells
by releasing cytotoxic proteins into the B-cells. A robust clinical
development programme for Lunsumio is ongoing, investigating the
molecule as a monotherapy and in combination with other medicines,
for the treatment of people with B-cell non-Hodgkin lymphomas,
including follicular lymphoma and diffuse large B-cell lymphoma,
and other blood cancers.About Polivy® (polatuzumab
vedotin)Polivy is a first-in-class anti-CD79b
antibody-drug conjugate (ADC). The CD79b protein is expressed in
the majority of B-cells, an immune cell impacted in some types of
non-Hodgkin lymphoma (NHL), making it a promising target for the
development of new therapies. Polivy binds to cancer cells such as
those expressing CD79b and destroys these B-cells through the
delivery of an anti-cancer agent, which is thought to minimise the
effects on normal cells. Polivy is being developed by Roche using
Seagen ADC technology and is currently being investigated for the
treatment of several types of NHL.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), Lunsumio®
(mosunetuzumab) and Columvi® (glofitamab). Our pipeline of
investigational haematology medicines includes T-cell engaging
bispecific antibody cevostamab, targeting both FcRH5 and CD3,
Tecentriq® (atezolizumab), 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 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 endeavour 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] Hutchings M, et al. Glofitamab
Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma:
Extended Follow-Up from a Pivotal Phase II Study and Subgroup
Analyses in Patients with Prior Chimeric Antigen Receptor T-Cell
Therapy and by Baseline Total Metabolic Tumor Volume. Presented at:
ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #433.[2]
Schuster S, et al. Mosunetuzumab Monotherapy Continues to
Demonstrate Durable Responses in Patients with Relapsed and/or
Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year
Follow-up from a Pivotal Phase II Study. Presented at: ASH Annual
Meeting and Exposition; 2023 Dec 9-12. Abstract #603.[3] Budde E,
et al. Mosunetuzumab Plus Polatuzumab Vedotin Demonstrates a
Favorable Safety Profile and Efficacy in Patients (Pts) with
Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Primary
Analysis of a Phase Ib/II Study. Presented at: ASH Annual Meeting
and Exposition; 2023 Dec 9-12. Abstract #613.[4] Topp M, et al.
Glofitamab Plus R-CHOP Induces High Response Rates with a
Manageable Safety Profile in Patients with Previously Untreated
Diffuse Large B-Cell Lymphoma (DLBCL): A 12-Month Analysis from a
Phase Ib Study. Presented at: ASH Annual Meeting and Exposition;
2023 Dec 9-12. Abstract #3085.[5] Flinn I, et al. Subcutaneous
Mosunetuzumab Is Active and Has a Manageable Safety Profile in
Patients with Previously Untreated, Low-Tumor Burden Follicular
Lymphoma: Initial Results from the Phase II Morningsun Study.
Presented at: ASH Annual Meeting and Exposition; 2023 Dec 9-12.
Abstract #3029.[6] Morschhauser F, et al. Preliminary Findings of a
Phase Ib/II Trial Indicate Manageable Safety and Promising Efficacy
for Mosunetuzumab in Combination with Lenalidomide (M+Len) in
Previously Untreated (1L) Follicular Lymphoma (FL). Presented at:
ASH Annual Meeting and Exposition; 2023 Dec 9-12. Abstract #605.[7]
Budde LE et al. Mosunetuzumab with polatuzumab vedotin in relapsed
or refractory aggressive large B cell lymphoma: a phase 1b/2 trial.
Nature Medicine.
2023. https://doi.org/10.1038/s41591-023-02726-5
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