What is the mechanism of action of this treatment?

Tafasitamab targets CD19 on B cells, leading to their destruction, while Lenalidomide enhances the immune response against cancer cells and inhibits their growth. Rituximab targets CD20 on B cells, causing their death through immune-mediated mechanisms. These targeted therapies are crucial for Marginal Zone Lymphoma patients as they specifically eliminate malignant B cells, potentially offering effective treatment with fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

The combination of tafasitamab, lenalidomide, and rituximab for treating Marginal Zone Lymphoma can lead to several side effects. Tafasitamab, a monoclonal antibody targeting CD19, may cause infusion-related reactions, neutropenia, and infections. Lenalidomide, an immunomodulatory drug, is associated with neutropenia, thrombocytopenia, fatigue, and an increased risk of infections. Rituximab, a monoclonal antibody targeting CD20, can cause infusion reactions, infections, and cytopenias. When used together, these drugs may increase the risk of severe neutropenia and infections, necessitating close monitoring and supportive care.

What prior FDA approvals exist?

For the treatment of Marginal Zone Lymphoma (MZL), the FDA has approved several therapies involving monoclonal antibodies and immunomodulatory drugs. Rituximab, a monoclonal antibody targeting CD20, has been a cornerstone in the treatment of MZL. Lenalidomide, an immunomodulatory drug, has also been used in combination with Rituximab to enhance anti-tumor immunity. More recently, combinations involving newer monoclonal antibodies like Tafasitamab, which targets CD19, are being studied to potentially offer improved efficacy. These treatments aim to leverage the complementary mechanisms of action of these drugs to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Tafasitamab and Lenalidomide as an add-on to Rituximab for Marginal Zone Lymphoma patients include: 1) Daratumumab (Monoclonal antibody targeting CD38) combined with Bortezomib and Dexamethasone, which has shown efficacy in multiple myeloma and could be considered for MZL. 2) Isatuximab (Monoclonal antibody targeting CD38) combined with Pomalidomide and Dexamethasone, which has been effective in relapsed/refractory multiple myeloma and may offer benefits for MZL. 3) Elotuzumab (Monoclonal antibody targeting SLAMF7) combined with Lenalidomide and Dexamethasone, which has shown promise in multiple myeloma and could be explored for MZL.

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Anti-tumor antibiotic

Tafasitamab + Lenalidomide + Rituximab for Follicular & Marginal Zone Lymphoma (InMIND Trial)

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL

ECOG performance status of 0 to 2

Must not have

Prior use of lenalidomide in combination with rituximab

Active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing if adding two drugs, tafasitamab and lenalidomide, to an existing treatment (rituximab) is more effective than just adding one drug (lenalidomide) for patients with certain types of lymphoma that have returned or not responded to treatment. The drugs aim to better target and destroy cancer cells while boosting the body's immune response against the cancer. Lenalidomide has shown activity in various lymphoma subtypes, including diffuse large B-cell lymphoma, and is often combined with rituximab for enhanced efficacy.

Who is the study for?

This trial is for adults with relapsed/refractory Follicular Lymphoma or Marginal Zone Lymphoma who've had prior anti-CD20 immunotherapy or chemo-immunotherapy. Participants must be able to take blood clot prevention meds, not be pregnant or breastfeeding, and have no major heart issues, active infections, HIV/HCV/HBV, CNS lymphoma involvement, or recent other lymphoma treatments.

What is being tested?

The study tests if adding Tafasitamab to the combination of Lenalidomide and Rituximab improves outcomes for patients compared to a placebo plus Lenalidomide and Rituximab. It's a Phase 3 trial where participants are randomly assigned to either the drug group or placebo group without knowing which one they're in.

What are the potential side effects?

Possible side effects include reactions at the infusion site, low blood counts leading to increased infection risk or bleeding problems, fatigue, rash, digestive issues like nausea and diarrhea. There may also be an increased risk of developing new cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is confirmed to be of a specific type and grade.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been treated with a therapy targeting CD20 before.

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My cancer has returned or worsened after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with lenalidomide and rituximab together.

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I am currently fighting an infection in my body.

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I have been diagnosed with congestive heart failure.

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My lymphoma is not follicular or marginal zone, and it has not transformed.

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I am not pregnant or breastfeeding.

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I have had cancer that did not affect my blood.

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My cancer affects the lymph nodes in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) in FL population

Secondary study objectives

Best Overall Response Rate in FL and overall population

Complete Response in FL population

Complete Response in Overall population

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A : tafasitamab + rituximab + lenalidomideExperimental Treatment3 Interventions

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Group II: Arm B : placebo+rituximab+lenalidomidePlacebo Group3 Interventions

Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tafasitamab

2021

Completed Phase 2

~60

rituximab

2000

Completed Phase 3

~2760

lenalidomide

2012

Completed Phase 3

~3370

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tafasitamab targets CD19 on B cells, leading to their destruction, while Lenalidomide enhances the immune response against cancer cells and inhibits their growth. Rituximab targets CD20 on B cells, causing their death through immune-mediated mechanisms. These targeted therapies are crucial for Marginal Zone Lymphoma patients as they specifically eliminate malignant B cells, potentially offering effective treatment with fewer side effects compared to traditional chemotherapy.

Challenges and Opportunities in the Management of Diffuse Large B-Cell Lymphoma in Older Patients.