Press Release: ASCO: Sarclisa is first anti-CD38 to significantly
improve progression-free survival in combination with VRd for newly
diagnosed transplant-ineligible multiple myeloma in phase 3
ASCO: Sarclisa is first anti-CD38 to significantly
improve progression-free survival in combination with VRd for newly
diagnosed transplant-ineligible multiple myeloma in phase 3
- Sarclisa, in
combination with standard-of-care bortezomib, lenalidomide and
dexamethasone (VRd) followed by Sarclisa-Rd reduced the risk of
recurrence or death by 40% versus VRd followed by Rd in the
investigational use for transplant-ineligible newly diagnosed
multiple myeloma patients
- Key primary endpoint
of progression-free survival met, demonstrating Sarclisa's
potential as a first-in-class combination to address gaps in care
for newly diagnosed transplant-ineligible patients
- Full data
simultaneously published in NEJM and formed the basis of regulatory
submissions
Paris, June 3, 2024. Data from
the IMROZ phase 3 study demonstrated Sarclisa (isatuximab) in
combination with standard-of-care bortezomib, lenalidomide and
dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen)
significantly reduced the risk of disease progression or death by
40%, compared to VRd followed by Rd in patients with newly
diagnosed multiple myeloma (NDMM) not eligible for transplant.
IMROZ is the first global phase 3 study of an anti-CD38 monoclonal
antibody in combination with standard-of-care VRd to significantly
improve PFS and show deep responses in this patient population who
often have poor prognoses. The results were shared in an oral
presentation at the American Society of Clinical Oncology (ASCO)
annual meeting and simultaneously published in the New England
Journal of Medicine (NEJM).
The use of Sarclisa in combination with VRd in
transplant-ineligible NDMM is investigational and has not been
fully evaluated by any regulatory authority.
Thierry Facon, MDProfessor of
Haematology in the Department of Haematology, Lille University
Hospital, Lille, France, member of French Academy of Medicine and
IMROZ Principal Investigator“The significant progression-free
survival benefit observed with Sarclisa combination therapy
compared to VRd is important and encouraging for patients with
newly diagnosed multiple myeloma. Effective frontline therapy has
the potential to modify the course of the disease, which is a key
outcome for transplant-ineligible patients who often face high
rates of attrition in later lines of therapy. The IMROZ results
demonstrate the promise of Sarclisa as a backbone to frontline
therapy, which may improve long-term outcomes for this incurable
disease.”
Key ResultsIMROZ is a global, randomized,
multi-center, open-label study. At the data cut-off of September
26, 2023, through the median follow-up of 59.7 months, the
following were observed for Sarclisa-VRd compared to VRd:
Primary endpoint
- 40% reduction in the risk
of disease progression or death for patients treated with
Sarclisa-VRd versus VRd (HR 0.596; 98.5% CI: 0.406 to
0.876; p=0.0005). At the median follow-up of 59.7 months, the
median PFS with the Sarclisa-VRd combination was not reached versus
54.3 months with VRd.
- The estimated PFS at 60
months was 63.2% for patients treated with Sarclisa-VRd
versus 45.2% for VRd.
Secondary endpoints
-
Approximately three-quarters (74.7%) of patients treated
with Sarclisa-VRd achieved a complete response (CR)
compared to 64.1% of patients taking VRd (OR 1.7; 95% CI:
1.097-2.5; p=0.008).
- More
than half (55.5%) of patients treated with Sarclisa-VRd achieved
MRD negative CR compared to 40.9% of patients taking VRd
(OR 1.8; 95% CI: 1.229-2.646; p=0.0013).
- MRD was
sustained for at least 12 months among nearly half (46.8%) of
patients in the Sarclisa-VRd arm compared to less than
one-quarter (24.3%) of patients taking VRd (OR 2.7; 95% CI:
1.799-4.141).
At the date of data cut-off, 47.2% of patients
(125/263) treated with Sarclisa-VRd and 24.3% of patients (44/181)
treated with VRd were still on treatment. The median treatment
duration for the Sarclisa-VRd combination was 53.2 months vs. 31.3
months for VRd.
The safety and tolerability of Sarclisa observed
in this study was consistent with the established safety profile of
Sarclisa-VRd with no new safety signals observed. Grade ≥3
treatment-emergent adverse events (TEAE) occurred in 91.6% of
patients taking Sarclisa-VRd and 84% of patients taking VRd.
Treatment-emergent events (TAE) of any grade led to treatment
discontinuation in 22.8% of patients taking Sarclisa-VRd and 26% of
patients taking VRd.
Peter C. AdamsonGlobal
Development Head, Oncology“Over the last 20 years, the pace of
multiple myeloma research has continued to accelerate, paving the
way for treatment advancements with potential to improve outcomes
for patients. With our commitment to help lead the way for patients
with this disease, we welcomed the IMROZ results presented at ASCO,
and now published in NEJM, which demonstrate Sarclisa’s potential
to improve progression-free survival in patients who are newly
diagnosed and transplant ineligible. We want to express our deep
gratitude to the patients, their families and investigators for
their dedication to clinical research.”
Advancing Sarclisa in Newly Diagnosed Multiple
MyelomaThe US Food and Drug Administration (FDA) accepted for
Priority Review the supplemental Biologics License Application
(sBLA) for the investigational use of Sarclisa in combination with
VRd for the treatment of patients with transplant-ineligible NDMM.
A regulatory submission is also under review in the European Union
(EU). If approved, Sarclisa would be the first anti-CD38 therapy in
combination with standard-of-care VRd in newly diagnosed patients
not eligible for transplant, which would be the third indication
for Sarclisa in multiple myeloma.
The IMROZ data will also be presented during the
plenary scientific session at the European Hematology Association
(EHA) Annual Congress on June 15, selected as one of the top six
abstracts to be featured at the congress. There will be two
additional oral presentations at EHA featuring results from phase 3
studies of Sarclisa in NDMM. Additionally, the IMROZ abstract was
hand-selected to be included in the 2024 Best of ASCO program, held
later in the summer of 2024, following the ASCO Annual Meeting.
Sanofi’s oncology pipeline and portfolio
prioritize areas of high unmet need for difficult-to-treat cancers,
including multiple myeloma, which remains an incurable disease
despite recent advances in treatment.
About the IMROZ studyThe randomized,
multi-center, open-label IMROZ phase 3 clinical study enrolled 446
patients with newly diagnosed, transplant-ineligible multiple
myeloma (MM) across 21 countries and 104 centers. During the study,
Sarclisa was administered through an intravenous infusion at a dose
of 10 mg/kg once weekly for five weeks during first 42-day cycle
and once every two weeks in cycles 2 to 4 in combination with
subcutaneous bortezomib, oral lenalidomide and intravenous or oral
dexamethasone. Then Sarclisa was administered every 2 weeks from
cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles
in combination with lenalidomide and dexamethasone at the standard
dose, until disease progression, unacceptable safety profile or
patient’s decision to stop the study treatment.
The primary endpoint was progression-free
survival. Key secondary endpoints include complete response rate,
MRD negativity rate for patients with a complete response, very
good partial response or better rate, overall survival. Other
secondary endpoints are: overall response rate, time to
progression, duration of response, time to first response, time to
best response, progression-free survival on next line of therapy,
progression-free survival by MRD status, sustained MRD negativity
greater than or equal to 12 months rate, safety, pharmacokinetic
profile, immunogenicity, disease-specific and generic
health-related quality of life, disease and treatment-related
symptoms, health state utility, and health status.1
The use of Sarclisa in combination with VRd in
transplant-ineligible newly diagnosed MM is investigational and has
not been fully evaluated by any regulatory authority.
About SarclisaSarclisa is a monoclonal antibody
that binds to a specific epitope on the CD38 receptor on multiple
myeloma (MM) cells, inducing distinct antitumor activity. It is
designed to work through multiple mechanisms of action including
programmed tumor cell death (apoptosis) and immunomodulatory
activity. CD38 is highly and uniformly expressed on the surface of
MM cells, making it a potential target for antibody-based
therapeutics such as Sarclisa.
Based on the ICARIA-MM phase 3 study, Sarclisa
is approved in >50 countries, including the US and EU, in
combination with pomalidomide and dexamethasone for the treatment
of patients with relapsed refractory MM (RRMM) who have received ≥2
prior therapies, including lenalidomide and a proteasome inhibitor
and who progressed on last therapy. Based on the IKEMA phase 3
study, Sarclisa is also approved in 50 countries in combination
with carfilzomib and dexamethasone, including in the US for the
treatment of patients with RRMM who have received 1–3 prior lines
of therapy and in the European Union for patients with MM who have
received at least 1 prior therapy. In the US, the generic name for
Sarclisa is isatuximab-irfc, with irfc as the suffix designated in
accordance with Nonproprietary Naming of Biological Products
Guidance for Industry issued by the US Food and Drug Administration
(FDA).
Sarclisa continues to be evaluated in multiple
ongoing phase 3 clinical studies in combination with current
standard treatments across the MM treatment continuum. It is also
under investigation for the treatment of other hematologic
malignancies, and its safety and efficacy have not been evaluated
by any regulatory authority outside of its approved indication.
For more information on Sarclisa clinical
studies, please visit www.clinicaltrials.gov.
About multiple myelomaMM is the second most
common hematologic malignancy,2 with more than 180,000 new
diagnoses of MM worldwide yearly.3 Despite available treatments, MM
remains an incurable malignancy with an estimated 52% five-year
survival rate for newly diagnosed patients.4 Since MM does not have
a cure, most patients will relapse. Since MM does not have a cure,
most patients will relapse. Relapsed MM is the term for when the
cancer returns after treatment or a period of remission. Refractory
MM refers to when the cancer does not respond or no longer responds
to therapy.
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1ClinicalTrials.gov.Identifier#NCT03319667.
https://clinicaltrials.gov/ct2/show/NCT03319667. Accessed September
2023.2 Kazandjian. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004.3 World Health Organization.
Multiple Myeloma. 35-multiple-myeloma-fact-sheet.pdf (who.int).
Accessed March 2024. 4 Fonseca, R.,
Usmani, S.Z., Mehra, M. et al. Frontline treatment patterns and
attrition rates by subsequent lines of therapy in patients with
newly diagnosed multiple myeloma. BMC
Cancer. 2020: 20(1087).
https://doi.org/10.1186/s12885-020-07503-y.
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