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

SARCLISA (isatuximab-irfc): Clinical Trials Update, Market Outlook, and Patent-Driven Generic/Biosimilar Risk

Last updated: July 28, 2026

SARCLISA (isatuximab-irfc) is a CD38-directed monoclonal antibody for relapsed/refractory multiple myeloma (RRMM). Commercial trajectory is tied to ongoing label expansion across earlier-line settings and to competitive dynamics with daratumumab-based regimens. The near- to mid-term market outlook hinges on (1) durability of uptake in combination regimens, (2) continuation of FDA approvals in expanded lines, and (3) how quickly peer CD38 antibodies reach “second-wave” share via sequencing and payer-driven step edits.

Clinical trials update summary (what matters for market projection)

• Isatuximab’s growth profile is linked to continued positive outcomes in combination studies in earlier lines (where depth of response and time-to-next-treatment drive adoption).
• The most material forward-looking signal for market expansion comes from readouts supporting use with standard backbones (lenalidomide/dexamethasone; bortezomib/dexamethasone; carfilzomib/dexamethasone) and for new patient types (transplant-ineligible and earlier RRMM) that broaden addressable populations.

Market projection summary (directional)

• Upside: broader label coverage and sustained uptake in regimen combinations that differentiate based on efficacy, tolerability, and treatment cadence.
• Downside: share pressure from daratumumab in similar combinations, payer restrictions, and slower than expected penetration of new indications.

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What is SARCLISA (isatuximab-irfc) and what indications drive its revenue?

SARCLISA (isatuximab-irfc) is approved for multiple myeloma in combination regimens in the relapsed setting. Revenue is primarily driven by:

• RRMM line-of-therapy positioning (later-line penetration first, then earlier-line expansion)
• Combination partner standard-of-care backbones (IMiDs and proteasome inhibitors)
• Treatment duration and discontinuation patterns driven by response durability and progression outcomes

How are SARCLISA regimens positioned versus standard CD38 antibody use?

CD38 monoclonal antibodies are typically adopted based on:

• demonstrated superiority or non-inferiority in key endpoints (ORR, DOR, PFS)
• tolerability and infusion administration logistics
• sequencing relative to other CD38 agents

Isatuximab’s market position is influenced by its clinical differentiation in regimen combinations and by label coverage that aligns with payer preferred drug lists.

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What are the latest SARCLISA clinical trial readouts and what do they signal for uptake?

Featured snippet answer: The most market-relevant updates are those that extend isatuximab into earlier-line RRMM or new subpopulations, and those that confirm response depth and durability when combined with established myeloma backbones.

Which trial categories most influence near-term prescribing?

1. Earlier-line RRMM expansion
   • Positive PFS and DOR in earlier lines changes “front-of-pack” prescribing because physicians treat earlier to reduce progression risk.
2. Triplet and quadruplet positioning
   • Combination regimens compete for use alongside daratumumab triplets. Adoption is driven by whether isatuximab adds clear incremental benefit in endpoints or safety.
3. Maintenance and consolidation strategies
   • If ongoing data supports durable disease control, it can convert patients from cyclic therapy to longer treatment spans.
4. High-risk cytogenetics and transplant-ineligible populations
   • Any signal that maintains efficacy in harder-to-treat subsets can broaden the payer and clinic adoption base.

What endpoint improvements typically move market share for CD38 antibodies?

• Higher ORR and deeper responses (CR or better rates) correlate with sustained treatment continuation.
• PFS and time-to-next-treatment influence both physician selection and payer authorization patterns.
• Safety that reduces discontinuations improves persistence, which is a major determinant of revenue in antibody regimens.

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When does SARCLISA lose exclusivity and what does the patent calendar imply for generic risk?

Featured snippet answer: SARCLISA’s generic entry timing is determined by patent expiries and biologic exclusivity (if applicable) plus any Orange Book-listed composition and method claims tied to its specific regimens and formulations. Without a confirmed, drug-product-specific patent list and expiry dates, an exclusivity calendar cannot be constructed here.

Which IP types typically block generic or biosimilar entry for monoclonal antibodies?

• composition-of-matter patents on the antibody
• formulation and device patents (stability, concentration, administration)
• method-of-use patents covering combination regimens and dosing sequences
• manufacturing process patents that can create regulatory and litigation barriers

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What patents protect SARCLISA and how strong is the patent estate for isatuximab?

Featured snippet answer: The strength of the patent estate for SARCLISA is driven by whether there are enforceable method-of-use and combination-regimen claims that map to current standard prescribing.

What matters for litigation leverage

• Remaining term on active claims
• Claim coverage that matches label regimen language
• Prior art robustness and obviousness susceptibility
• Whether challengers have “design-around” paths through different dosing or combinations

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What generic entry risks exist for SARCLISA and how likely are Paragraph IV challenges?

Featured snippet answer: For CD38 monoclonal antibodies marketed as biologics, generic entry is usually handled through biosimilar pathways rather than conventional Paragraph IV small-molecule triggers, with litigation occurring through BLA biosimilar-related mechanisms.

What is the biosimilar risk profile for isatuximab?

Biosimilar risk depends on:

• availability of viable reference product material and manufacturing comparability
• the scope of method-of-use protection
• whether interchangeability is pursued and supported (where relevant)
• active injunction risk and settlement terms

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What is the Orange Book status of SARCLISA and which FDA listings are relevant?

Featured snippet answer: The key FDA status signals for market exclusivity are contained in FDA databases and associated exclusivity records, including product listing and exclusivity flags.

Where to focus inside FDA data for competitive planning

• whether the product is listed as biologic and how exclusivity is recorded
• any related patents tied to the reference product
• whether other sponsors are listed with biosimilar development pathways

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How does SARCLISA compare with daratumumab and other CD38 regimens for RRMM?

Featured snippet answer: Market share between CD38 antibodies hinges on regimen-specific efficacy, patient subgroups, safety, infusion/administration experience, and payer preference based on total cost of therapy.

Commercial comparison dimensions

• choice of backbone: lenalidomide/dexamethasone vs proteasome inhibitor-based regimens
• expected persistence and discontinuation rates
• integration into treatment pathways (front-line RRMM sequencing)
• depth of response and time-to-treatment failure

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Which companies are challenging SARCLISA and what biosimilar pipeline threats exist?

Featured snippet answer: Competitive threat comes from biosimilar developers pursuing comparability programs for isatuximab and from alternative CD38 antibodies with stronger payer positioning.

What to track for threat escalation

• formal biosimilar development milestones
• FDA submissions and acceptance status
• litigation filings linked to reference product patents
• settlement agreements that set launch dates or carve-outs

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What trial designs and endpoints determine SARCLISA’s next label expansion?

Featured snippet answer: Label expansion for SARCLISA is driven by randomized controlled evidence comparing combination regimens against standard-of-care arms, with endpoint sets that support clinical meaningfulness for earlier-line treatment.

Most label-expansion-friendly endpoint packages

• PFS and OS (or validated surrogate endpoints)
• ORR with duration metrics
• subgroup analyses in clinically used decision groups

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What is the likely market size and revenue scenario for SARCLISA through the next 5 years?

Featured snippet answer: SARCLISA’s 5-year market path is most sensitive to earlier-line uptake and whether safety and durability sustain high persistence relative to competing CD38 regimens.

Scenario framework for business planning

Use a three-track model anchored to:

1. Base case: steady incremental share from label expansion; persistence remains stable; payer restrictions are manageable.
2. Upside case: faster than expected uptake in earlier lines driven by superior or more durable outcomes; reduced discontinuations.
3. Downside case: share shifts to daratumumab combinations; payer step edits and formulary limitations cap volume growth.

What variables move the projection up or down

• adoption speed by line of therapy
• conversion of newly eligible populations
• market access and contract renewal cycle
• changes in clinical guidelines and consensus panels
• competitive drug discounting and patient assistance dynamics

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How do manufacturing and supply constraints affect SARCLISA’s market outlook?

Featured snippet answer: For monoclonal antibodies, supply and manufacturing reliability affect fulfillment rate, which translates into revenue through persistence and avoidance of treatment interruptions.

Risk areas to monitor

• scale-up execution for higher volume
• lot release timelines
• cold-chain logistics and distribution capacity

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Key takeaways

• SARCLISA’s commercial outlook depends on continued label expansion in multiple myeloma lines where combination efficacy and treatment durability drive adoption.
• Market share is primarily competitive versus other CD38-directed regimens, especially daratumumab-based standards.
• Patent and biosimilar risk must be assessed via drug-product-specific patent calendars and FDA listings; without those inputs here, a defensible exclusivity and launch calendar cannot be produced.

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FAQs

1. Which SARCLISA trial results are most predictive of earlier-line multiple myeloma adoption?
2. How does treatment persistence with SARCLISA influence real-world revenue versus trial discontinuation rates?
3. What biosimilar or competitive programs most threaten SARCLISA’s share in RRMM?
4. How do payer formularies typically affect CD38 antibody adoption in combination regimens?
5. What endpoints do regulators and payers prioritize for new isatuximab combinations in multiple myeloma?

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References (APA)

1. (No sources provided in the prompt.)