European Commission approves Roche’s fixed-duration Columvi
(glofitamab) for people with relapsed or refractory diffuse large
B-cell lymphoma
- Columvi is the first CD20xCD3 T-cell-engaging bispecific
antibody available in Europe to treat the most common and
aggressive form of lymphoma
- Approval is based on results from the phase I/II NP30179
study, where Columvi given as a fixed course induced early and
long-lasting complete responses in people with heavily pre-treated
or refractory diffuse large B-cell lymphoma1
- Columvi is given for a fixed period of time and made to be
readily available, providing patients with a treatment end date and
treatment-free period
Basel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Commission (EC) has granted
conditional marketing authorisation for Columvi® (glofitamab) for
the treatment of adult patients with relapsed or refractory (R/R)
diffuse large B-cell lymphoma (DLBCL) after two or more lines of
systemic therapy. With this approval, Columvi is the first CD20xCD3
T-cell-engaging bispecific antibody available to treat people in
Europe with the most common and aggressive form of lymphoma
following multiple lines of therapy. Columvi has the potential to
change the current standard of care in DLBCL. As well as inducing
early and long-lasting responses in people with heavily pre-treated
or refractory DLBCL, Columvi is designed to be given for a fixed
period of time meaning that people have a target end date for their
course of treatment and the possibility of a treatment-free period.
It is also a chemotherapy-free treatment option that is
off-the-shelf, meaning that people do not have to wait for cell
collection and genetic engineering - a multistep process that can
take several weeks - before starting treatment. This could be
particularly important for patients who are at a high-risk of their
disease progressing.
DLBCL is an aggressive (fast-growing) type of lymphoma and is
one of the most prevalent types of blood cancer among adults.2 Each
year in Europe, an estimated 36,000 people are diagnosed with
DLBCL.3 While many patients with DLBCL are responsive to initial
treatment, four out of ten are not cured with the current standard
of care, frontline treatment, and the majority of patients who
require subsequent lines of therapy have poor outcomes.4,5
“As pioneers in the development of innovative T-cell-engaging
bispecific antibodies, we are delighted that we can now offer
Columvi as the first approved treatment of its kind to people in
Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “We are confident
that thanks to its off-the-shelf availability, fixed-duration
regimen and durability, Columvi will positively transform the
treatment experience for relapsed or refractory diffuse large
B-cell lymphoma.”
“As the lead investigator for the NP30179 study, I have seen
first-hand the early and long-lasting responses that Columvi can
induce, when given to patients for a fixed period of time,” said
Michael Dickinson, M.D., Ph.D., principal study investigator and
Associate Professor, Peter MacCallum Cancer Centre and Royal
Melbourne Hospital, Australia. “It is exciting that with this
approval, patients in Europe with heavily pre-treated or refractory
diffuse large B-cell lymphoma will now have a new, potentially
practice-changing treatment option that will allow them time off of
therapy to resume their routine activities, helping to alleviate
some of the physical and emotional burdens caused by cancer
treatment.”
The approval is based on positive results from a pivotal cohort
in the phase I/II NP30179 study, where Columvi given as a fixed
course induced early and long-lasting responses in people with R/R
DLBCL. Overall, 83.3% of patients were refractory to their most
recent therapy, 90% were refractory to any previous line of
therapy, and about one-third (35.2%) had received prior CAR T-cell
therapy. Results showed that Columvi given as a fixed course,
induced a complete response (CR; a disappearance of all signs of
cancer) in 35.2% (n =38/108) of people, and 50% (n=54/108) achieved
an overall response (OR; the combination of CR and partial
response, a decrease in the amount of cancer in their body). Among
those who achieved a CR, 74.6% (95% CI: 59.19-89.93) continued to
experience a response at 12 months, while the median duration of CR
was not reached. The median follow-up for duration of response
(DOR) was 12.8 months. Median time to first CR was 42 days (95% CI:
41-47). The most common adverse events (AEs) were cytokine release
syndrome (CRS; 64.3%), neutropenia (a reduction in white blood
cells [37.7%]), anaemia (30.5%) and thrombocytopenia (low blood
platelet count [24.7%]). CRS was generally low grade (Grade 1:
48.1%; Grade 2: 12.3%). One patient discontinued treatment due to
CRS.1
Additional data from a larger cohort in the NP30179 study,
published in the New England Journal of Medicine reinforce the
durability of Columvi. Fixed-duration Columvi resulted in early and
long-lasting responses in people with heavily pre-treated or
refractory DLBCL, with 39.4% of patients (n=61/155) achieving a CR
and a median DOR of 18.4 months. Median time to CR was 42 days (95%
CI: 42-44), with the majority of responses reported at the first
scheduled response assessment (approximately 1.4 months after the
start of treatment). Half of patients (51.6%; n=80/155) achieved an
OR. The most common AE was CRS, which was generally low grade
(Grade 1: 47.4%; Grade 2: 11.7%) and occurred at initial doses.
Columvi-related AEs leading to treatment discontinuation occurred
in 3.2% of patients.6
The U.S. Food and Drug Administration (FDA) recently approved
Columvi for the treatment of adult patients with R/R DLBCL not
otherwise specified or large B-cell lymphoma (LBCL) arising from
FL, after two or more lines of systemic therapy for the treatment
of people with R/R large B cell lymphoma. Columvi is also approved
in Canada for the treatment of adult patients with R/R DLBCL not
otherwise specified, DLBCL arising from follicular lymphoma (FL),
or primary mediastinal B-cell lymphoma, who have received two or
more lines of systemic therapy and are ineligible to receive or
cannot receive CAR T-cell therapy or have previously received CAR
T-cell therapy. Submissions to additional health authorities
worldwide are ongoing.
Roche is continually building on its long-standing expertise in
haematology by investigating innovative solutions that redefine
treatment standards for patients and improve on existing standards
of care. In a broad and industry-leading CD20xCD3 T-cell-engaging
bispecific antibody clinical development programme, Roche is
exploring the potential of both Columvi and Lunsumio®
(mosunetuzumab) in earlier lines of treatment and in combination
with other novel and chemotherapy-free agents, such as Polivy®
(polatuzumab vedotin), with the goal of providing patients with
long-lasting outcomes.
Roche continues to expand Columvi’s clinical development
programme, which includes the phase III STARGLO trial, evaluating
Columvi in combination with gemcitabine and oxaliplatin (GemOx)
versus rituximab in combination with GemOx in patients with
second-line plus DLBCL who are ineligible for autologous stem cell
transplant. Additional phase III studies are also planned,
including in first-line DLBCL.
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 the NP30179 studyThe
NP30179 study [NCT03075696] is a phase I/II, multicentre,
open-label, dose-escalation and expansion study evaluating the
safety, efficacy and pharmacokinetics of Columvi® (glofitamab) in
people with relapsed or refractory diffuse large B-cell lymphoma.
Outcome measures include complete response rate by an independent
review committee (primary endpoint), overall response rate,
duration of response, progression-free survival, safety, and
tolerability (secondary endpoints).
About diffuse large B-cell lymphoma (DLBCL)DLBCL is the
most common form of non-Hodgkin lymphoma (NHL), accounting for
about one in three cases of NHL.2 DLBCL is an aggressive
(fast-growing) type of NHL.2 While it is generally responsive to
treatment in the frontline, as many as 40% of people will relapse
or have refractory disease, at which time salvage therapy options
are limited and survival is short.4,5 Improving treatments earlier
in the course of the disease and providing needed alternative
options could help to improve long-term outcomes. Each year in
Europe, it is estimated that 36,000 people are diagnosed with
DLBCL.3
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 a T-cell-engaging bispecific antibody 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 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] Columvi, European Medicines Agency Summary
of Product Characteristics.[2] Cancer.Net. Lymphoma - Non-Hodgkin:
Subtypes. [Internet; cited April 2023]. Available from:
https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.[3]
Calculation for Worldwide incidence: World Health Organization.
GLOBOCAN 2020, Cancer Incidence and Mortality: IARC CancerBase No.
11 [Internet; cited April 2023]. Available from:
https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=908&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-1-4-0.[4]
Maurer MJ et al. Event-free survival at 24 months is a robust end
point for disease-related outcome in diffuse large B-cell lymphoma
treated with immunochemotherapy. J Clin Oncol. 2014;32:1066-73.[5]
Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: optimizing
outcome in the context of clinical and biologic heterogeneity.
Blood. 2015;125(1):22-32.[6] Dickinson MJ et al. Glofitamab for
Relapsed or Refractory Diffuse Large B-Cell Lymphoma. The New
England Journal of Medicine. 2022. doi: 10.1056/NEJMoa2206913.
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