Phase 3 trial of isatuximab combination therapy showed 40% reduction in the risk of disease progression or death for patients...
02 Juni 2019 - 04:46PM
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. |
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Media Relations Contact
Ashleigh Koss Tel.: +1 908-981-8745 Ashleigh.Koss@sanofi.com |
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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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