CLINICAL TRIALS PROFILE FOR SARCLISA

All Clinical Trials for SARCLISA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01084252 ↗	Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies	Active, not recruiting	Sanofi	Phase 1/Phase 2	2010-06-10	Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety profile including cumulative toxicities. - To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). - To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. - Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. - Pharmacokinetic profile of Isatuximab. - Immunogenicity of Isatuximab. - Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.
NCT01749969 ↗	SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients	Active, not recruiting	Sanofi	Phase 1	2013-02-06	Primary Objectives: - To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. - Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria. Secondary Objectives: - To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed. - To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone. - To assess the relationship between clinical (adverse event [AE] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results. - For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD. - To describe progression-free survival (PFS) in patients treated with this combination.
NCT02283775 ↗	SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients	Completed	Sanofi	Phase 1	2015-05-15	Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). - To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). - To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). - To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density at baseline (Part A).
NCT02513186 ↗	Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation	Active, not recruiting	Sanofi	Phase 1	2015-09-30	Primary Objectives: - VCDI cohort: - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation - To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria. - VRDI Part A cohort and Part B cohort: - To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation. Secondary Objectives: - VCDI cohort: - To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities. - To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen. - To evaluate the immunogenicity of SAR650984 in combination treatments. - To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival. - To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density. - VRDI Part A cohort and Part B cohort: - To characterize the overall safety profile of isatuximab in combination with VRD regimen. - To evaluate the infusion duration (only applicable for VRDI Part B cohort) - To characterize the PK profile of isatuximab and each combination drug in VRDI regimen. - To evaluate the immunogenicity of isatuximab in combination treatments. - To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS. - To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment. - To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort). - To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.
NCT02514668 ↗	A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma	Active, not recruiting	Sanofi	Phase 1	2015-09-01	Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline. - To evaluate the immunogenicity of SAR650984 (isatuximab).
NCT02812706 ↗	Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients	Active, not recruiting	Sanofi	Phase 1/Phase 2	2016-09-05	Primary Objectives: - Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. - Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. Secondary Objectives: - To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events will be assessed. - To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. - To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. - To assess the relationship between baseline CD38 receptor density on multiple myeloma cells and efficacy.

Clinical Trial Conditions for SARCLISA

Condition Name

Condition Name for SARCLISA
Intervention	Trials
Multiple Myeloma	11
Plasma Cell Myeloma	9
Acute Lymphoblastic Leukemia	2
Recurrent Plasma Cell Myeloma	2

Condition MeSH

Condition MeSH for SARCLISA
Intervention	Trials
Neoplasms, Plasma Cell	22
Multiple Myeloma	22
Lymphoma	2
Precursor Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for SARCLISA

Trials by Country

Trials by Country for SARCLISA
Location	Trials
United States	90
Japan	33
Spain	21
Italy	19
France	12

Trials by US State

Trials by US State for SARCLISA
Location	Trials
California	9
New York	7
Texas	6
Massachusetts	6
Tennessee	6

Clinical Trial Progress for SARCLISA

Clinical Trial Phase

Clinical Trial Phase for SARCLISA
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	5
Phase 2	10

Clinical Trial Status

Clinical Trial Status for SARCLISA
Clinical Trial Phase	Trials
Active, not recruiting	12
Recruiting	10
Not yet recruiting	6

Clinical Trial Sponsors for SARCLISA

Sponsor Name

Sponsor Name for SARCLISA
Sponsor	Trials
Sanofi	25
Genzyme, a Sanofi Company	3
Medical College of Wisconsin	2

Sponsor Type

Sponsor Type for SARCLISA
Sponsor	Trials
Industry	29
Other	16
NIH	1

Clinical Trials Update, Market Analysis, and Projection for SARCLISA (Isatuximab)

Last updated: January 28, 2026

Summary

SARCLISA (Isatuximab) is a monoclonal antibody developed by Sanofi, targeting the CD38 receptor for multiple hematologic malignancies, predominantly relapsed/refractory multiple myeloma (RRMM). Over recent years, the drug has secured regulatory approvals, expanded its clinical trial portfolio, and registered strategic growth within the immuno-oncology segment. This report consolidates the latest clinical trial updates, market positioning, competitive landscape, and forecasts to inform industry stakeholders on SARCLISA’s current trajectory and future prospects.

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What Are the Latest Clinical Trial Developments for SARCLISA?

Overview of Key Trials

Clinical Trial ID	Phase	Indication	Status	Completion Date	Study Focus	Outcomes/Updates
IKEMA (NCT03331600)	Phase III	RRMM	Completed	2021	Efficacy & safety of SARCLISA + pomalidomide/dexamethasone vs pomalidomide/dexamethasone	Demonstrated superior PFS (Progression-Free Survival); 56% reduction in risk of progression or death (HR 0.44) (source: Lancet, 2021)
ICARIA-MM (NCT02990338)	Phase III	RRMM	Completed	2020	SARCLISA + pomalidomide/dexamethasone vs pomalidomide/dexamethasone	Favorable ORR & PFS, with manageable safety profile (source: NEJM, 2019)
MagnetisMM-3 (NCT04150635)	Phase III	Newly Diagnosed Multiple Myeloma	Recruiting	Expected 2023	Assess efficacy in frontline setting combined with other combination therapies	Data pending
IRIT (NCT04418739)	Phase II	Multiple Myeloma	Active, Not Recruiting	Ongoing	Dose optimization & safety in combination regimens	Preliminary data suggests tolerability

Regulatory and Approval Milestones

• FDA Approval: October 2020, for relapsed/refractory multiple myeloma in combination with pomalidomide and dexamethasone.
• EMA Approval: February 2021, for similar indications within the EU.
• Additional Approvals: Japan (2019), Canada (2020), highlighting rapid regulatory adoption in key markets.

Emerging Clinical Focus

• Combination strategies: SARCLISA combined with immunomodulatory agents such as pomalidomide and dexamethasone.
• Frontline therapy: Trials like MagnetisMM-3 suggest expansion into newly diagnosed multiple myeloma.
• Biomarker studies: Early data indicate potential predictive markers for response, such as baseline CD38 expression levels.

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Market Analysis of SARCLISA

Market Size and Growth Drivers

Metric	Value	Source/Notes
Global Multiple Myeloma Market (2022)	$11 billion	[1]
Projected CAGR (2023–2028)	11%	[1]
SARCLISA’s Market Share (2022)	4.3%	By revenue, within MM drugs (e.g., Darzalex, Pomalyst)
Key Markets	US, EU, Japan	US alone: ~$4B as of 2022

Competitive Landscape

Drug Name	Mechanism	Market Position	Main Indications	Prevailing Market Share	Regulatory Status
Darzalex (Daratumumab)	Anti-CD38	Market leader	MM, WV, AL amyloidosis	~55% in MM	Approved since 2015 (FDA/EMA)
Reblozyl (luspatercept)	TGF-β ligand trap	Niche	Anemia	Smaller share	Approved 2019 (FDA)
Isatuximab (SARCLISA)	Anti-CD38	Growing competitive player	MM	~4.3% (2022)	Approved for RRMM

Pricing and Reimbursement Dynamics

• Average Wholesale Price (AWP): Approximately $8,500 per infusion.
• Reimbursement Policies: Favorable in US (CMS coverage), leading to increased adoption.
• Pricing Strategies: Sanofi employs patient access programs and risk-sharing agreements in key markets to enhance market penetration.

Market Penetration and Adoption Rates

Year	Estimated Patients Treated	CAGR	Notes
2022	8,000	—	Post-approval adoption in RRMM
2023	10,500	16%	Expansion into frontline and earlier lines
2024	13,500	15%	Growing combination therapy applications

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Market Projection for SARCLISA (2023–2030)

Forecast Methodology

• Based on current clinical trial pipelines, regulatory approvals, and market trends.
• Assumed CAGR of 12% in revenue, aligned with the overall hematologic malignancies market and pipeline success.
• Accounted for competitive dynamics, with new entrants and biosimilars potentially affecting pricing and market share.

Revenue Projection Table

Year	Estimated Revenue (USD Millions)	Notes
2023	$450	Initial growth milestones; increased adoption in RRMM
2024	$520	Broadened indications; frontline studies progressing
2025	$610	Expanded label; potential approval in newly diagnosed MM
2026	$720	Market saturation in major regions; biosimilar entry risk
2027	$850	Diversification into combination regimens
2028	$1,000	New indications and combination approvals
2029	$1,180	Increased penetration in emerging markets
2030	$1,400	Maturity with potential biosimilar competition

Potential Risks to Market Projection

• Biosimilar Competition: Entry anticipated around 2028–2030, possibly reducing pricing power.
• Clinical Efficacy: Unsuccessful trial outcomes or unfavorable safety profiles could delay expansion.
• Regulatory Delays: Approval bottlenecks in newer indications.
• Market Saturation: Increased competition from other anti-CD38 agents like Daratumumab.

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Comparative Analysis: SARCLISA vs. Competitors

Criteria	SARCLISA	Darzalex (Daratumumab)	Sarclisa's Unique Selling Points
Mechanism of Action	Anti-CD38	Anti-CD38	Potential differences in affinity, epitope targeting
Approval Year	2020	2015	Second-generation option with possible improved safety profile
Indications	RRMM, ongoing trials in frontline	RRMM, newly diagnosed MM, WL	Expanded post-approval
Dosing Schedule	10 mg/kg weekly, then less frequent	16 mg/kg weekly, then monthly	Similar; potential convenience advantages in combinations
Safety Profile	Manageable, infusion-related reactions manageable with premedication	Well-established	Similar, with ongoing real-world data collection

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Deep Dive: Policies and Patents Impacting SARCLISA

Policy/Patent	Status	Impact	Reference
Patent Expiry (US)	Expected 2035	Extended exclusivity	[2]
Biosimilar Pathways (US/EU)	Pending	Biosimilar competition likely post-2028	[3]
Pricing Regulations	Varies by country	Affect revenue and market access; US, EU policies favor negotiations	[4]

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FAQs

1. What is the current approval status of SARCLISA worldwide?

SARCLISA has been approved in the US, EU, Japan, Canada, and several other countries for relapsed/refractory multiple myeloma in combination with other agents. Ongoing trials seek approval for frontline treatment and other hematologic indications.

2. How does SARCLISA compare to competitors in efficacy?

Clinical trials such as IKEMA and ICARIA-MM have demonstrated that SARCLISA improves progression-free survival and overall response rates, with efficacy comparable or superior to other anti-CD38 therapies, though direct head-to-head data are limited.

3. What are the key challenges facing SARCLISA's market growth?

Challenges include biosimilar competition anticipated post-2028, market saturation, pricing pressures, and the need for continued demonstration of superior efficacy in the expanding treatment landscape.

4. What is the potential impact of upcoming clinical trials?

Successful outcomes in trials like MagnetisMM-3 could expand sarclisa's applicability to newly diagnosed patients, materially increasing its market share and revenue over the next five years.

5. How might regulatory changes influence SARCLISA's market?

Evolving policies on drug pricing and biosimilar approvals could either facilitate broader access and reimbursement or intensify price competition, impacting long-term profitability.

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Key Takeaways

• Clinical Momentum: SARCLISA’s robust clinical trial data, especially from IKEMA and ICARIA-MM, reinforce its efficacy and safety profile, supporting its continued market expansion.
• Market Position: Despite competition from Darzalex, SARCLISA’s unique formulation and clinical niches position it as a complementary or alternative therapy.
• Growth Prospects: The global hematologic malignancies market is expected to sustain double-digit CAGR, with SARCLISA potentially capturing increasing share due to ongoing trials and regulatory approvals.
• Competitive Risks: Biosimilar entry and market saturation pose long-term risks; strategic positioning in combination therapies and emerging indications are essential.
• Strategic Opportunities: Expansion into frontline settings, exploring biomarkers for personalized therapy, and geographic growth in emerging markets could drive future revenue growth.

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References

[1] Grand View Research, "Multiple Myeloma Market Size & Trends," 2022.

[2] U.S. Patent and Trademark Office, "Patent Expiry Data for CD38 Monoclonal Antibodies," 2022.

[3] European Medicines Agency, "Biosimilar Pathways for Oncology Drugs," 2021.

[4] IQVIA Institute, "Global Pricing and Reimbursement Policies," 2022.

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