Phase 3 trial of isatuximab combination therapy showed 40% reduction in the risk of disease progression or death for patients...
03 June 2019 - 12:45AM
Phase 3 trial of isatuximab combination therapy showed 40%
reduction in the risk of disease progression or death for patients
with relapsed/refractory multiple myeloma
News Summary:
- Isatuximab, an
investigational anti-CD38 monoclonal antibody, added to
pomalidomide and dexamethasone prolonged progression free survival
by 5 months compared to pomalidomide and dexamethasone alone (11.53
vs. 6.47 months, p=0.001, HR 0.596)
- Overall response rate
significantly greater with isatuximab combination therapy compared
to pomalidomide and dexamethasone (60% vs. 35%,
p<0.0001)
- First positive randomized Phase
3 trial to evaluate an antibody in combination with pomalidomide
and dexamethasone presented at this year's ASCO annual
meeting
- European Medicines Agency
accepted for review the Marketing Authorization Application for
isatuximab
Paris - June 2, 2019 - Pivotal Phase 3
ICARIA-MM trial results demonstrated that isatuximab added to
pomalidomide and dexamethasone (isatuximab combination therapy)
showed statistically significant improvements compared to
pomalidomide and dexamethasone (pom-dex) alone in patients with
relapsed/refractory multiple myeloma (RRMM).
These findings were presented today at the 2019 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago. Isatuximab is
an investigational monoclonal antibody that targets a specific
epitope on the CD38 receptor of a plasma cell.
"Isatuximab in combination with pomalidomide and dexamethasone
resulted in an impressive 40% reduction in the risk of progression
or death compared to pomalidomide and dexamethasone alone,"
said Paul Richardson, MD, principal investigator and clinical
program leader and director of clinical research at the Jerome
Lipper Multiple Myeloma Center at Dana-Farber Cancer
Institute. "This outcome is noteworthy because
this trial included a particularly difficult-to-treat, relapsed and
refractory patient population that was, in my view, highly
reflective of real-world practice."
Isatuximab combination therapy showed a statistically significant
improvement in progression free survival (HR 0.596, 95% CI
0.44-0.81, p=0.001), and the median progression free survival was
longer in the isatuximab combination therapy arm (11.53 months, 95%
CI: 8.936 to 13.897) than pom-dex alone (6.47 months, 95% CI: 4.468
to 8.279).
Also of note, isatuximab combination therapy demonstrated a
significantly greater overall response rate, compared to pom-dex
alone (60% vs. 35%, p<0.0001). In additional analyses,
isatuximab combination therapy compared to pom-dex alone showed a
treatment benefit consistent across multiple subgroups, including
patients 75 years and older, patients with renal insufficiency, and
patients who were refractory to lenalidomide. The results presented
above were based on an independent review committee
assessment.
In addition, the following results favored isatuximab combination
therapy:
-
Isatuximab combination therapy demonstrated
significantly higher very good partial response (VGPR) rate
compared to pom-dex (31.8% vs. 8.5%, respectively, p<0.0001) and
a longer duration of response compared to pom-dex alone (median
13.27 months vs. 11.07 months, respectively). Among patients who
achieved a response, isatuximab combination therapy demonstrated
faster median time to first response compared to pom-dex alone (35
days vs. 58 days, respectively).
-
Time to next treatment was longer with
isatuximab combination therapy compared to pom-dex alone (median
not reached vs. 9.1 months, HR=0.538).
-
Data at the time of analysis showed a trend
towards an overall survival benefit associated with isatuximab
combination therapy. Final data on overall survival will be
reported when available.
Adverse events (AEs) of Grade >=3 were observed in 86.8% of
isatuximab combination therapy patients vs. 70.5% of pom-dex
patients. Additionally, isatuximab combination therapy compared to
pom-dex showed: 7.2% vs. 12.8% of patients discontinued due to AEs,
respectively; 7.9% vs. 9.4% patients died due to AEs, respectively;
infections of Grade >=3 were seen in 42.8% vs. 30.2% of
patients, respectively; and Grade >=3 neutropenia was seen
in 84.9% (febrile 11.8%) vs. 70.1% (febrile 2.0%) of patients,
respectively. Infusion reactions were reported in 38.2% (2.6% grade
3-4) of isatuximab combination therapy patients.
First Positive Phase 3 Trial of a Monoclonal Antibody in
Combination with Pom-Dex
ICARIA-MM is a pivotal Phase 3 randomized, open-label, multi-center
trial evaluating isatuximab in combination with pom-dex versus
pom-dex alone in patients with RRMM. The study enrolled 307
patients with RRMM across 96 centers spanning 24 countries.
Overall, patients had received a median of three prior lines of
anti-myeloma therapies, including at least two consecutive cycles
of lenalidomide and a proteasome inhibitor given alone or in
combination.
During the trial, isatuximab was administered through an
intravenous infusion at a dose of 10mg/kg once weekly for four
weeks, then every other week for 28-day cycles in combination with
standard doses of pom-dex for the duration of treatment.
Topline results from ICARIA-MM were previously announced in
February 2019.
Developing Isatuximab, a Monoclonal Antibody
Isatuximab is an investigational monoclonal antibody (mAb)
targeting a specific epitope on the CD38 receptor. It is designed
to trigger multiple, distinct mechanisms of action that are
believed to directly promote programmed tumor cell death
(apoptosis) and immunomodulatory activity. CD38 is highly and
uniformly expressed on multiple myeloma cells and is a cell surface
receptor target for antibody-based therapeutics in multiple myeloma
and other malignancies. The clinical significance of these findings
is under investigation.
Isatuximab is being developed by Sanofi and is currently being
evaluated in multiple ongoing Phase 3 clinical trials in
combination with currently available treatments across the multiple
myeloma treatment continuum.
In the second quarter of 2019, the European Medicines Agency (EMA)
accepted for review the Marketing Authorization Application and
Sanofi filed a Biologics License Application with the U.S. Food and
Drug Administration (FDA), both for use of isatuximab in
combination with pom-dex for the treatment of certain patients with
RRMM.
Isatuximab is also under investigation for the treatment of other
hematologic malignancies and solid tumors. Isatuximab is an
investigational agent and its safety and efficacy have not been
evaluated by the U.S. FDA, the EMA, or any other regulatory
authority.
Multiple Myeloma Leads to Significant Disease Burden
Multiple myeloma is the second most common hematologic
malignancy[1], affecting
more than 138,000[2] people
worldwide. Multiple myeloma results in significant disease burden.
Patients with multiple myeloma continue to relapse over time making
it a difficult to treat and incurable malignancy.
|
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
|
Media Relations Contact Ashleigh
Koss
Tel.: +1 908-981-8745
Ashleigh.Koss@sanofi.com
|
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com |
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|
[1] Kazandjian.
Multiple myeloma epidemiology and survival: A unique malignancy.
Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.004
[2] Cowan AJ,
Allen C, Barac A, et al. Global Burden of Multiple Myeloma: A
Systematic Analysis for the Global Burden of Disease Study 2016.
JAMA Oncol. 2018;4(9):1221-1227.
doi:10.1001/jamaoncol.2018.2128
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Source: Sanofi via Globenewswire
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