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This email is sponsored by Incyte.
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Tafasitamab-cxix + R2—the first and only CD19- and CD20-targeted immunotherapy combination approved for 2L+ follicular lymphoma patients1
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Tafasitamab-cxix + R2
—the first and only
CD19- and CD20-
targeted
immunotherapy
combination approved
for 2L+ follicular
lymphoma patients1
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Dear Healthcare Professional,
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Tafasitamab-cxix, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
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Limitations of Use: Tafasitamab-cxix is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
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Median PFS† by IRC assessment (secondary endpoint) was not reached (95% CI: 19.3 months, NE) with tafasitamab-cxix + R2 (n=273) vs 16 months (95% CI: 13.9, 21.1) with R2 (n=275) (HR‡=0.41 [95% CI: 0.29, 0.56]).2
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There was a 59% risk reduction in disease progression or death with tafasitamab-cxix + R2 vs R2 as assessed by IRC.2
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PFS by IRC assessment was not formally tested for statistical significance.
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Median PFS† by investigator assessment (primary endpoint) was 22.4 months (95% CI: 19.2, NE) with tafasitamab-cxix + R2 (n=273) vs 13.9 months (95% CI: 11.5, 16.4) with R2 (n=275) (HR‡=0.43 [95% CI: 0.32, 0.58]; P<0.0001) after a median follow-up of 14.1 months.1
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There was a 57% risk reduction in disease progression or death with tafasitamab-cxix + R2 vs R2 as assessed by investigator.1
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†Kaplan-Meier estimates.1,2
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| ‡ | Hazard ratio based on a stratified Cox proportional hazards model.1,2 |
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In an exploratory analysis, median time to next treatment was not reached with tafasitamab-cxix + R2 vs 28.8 months with R2.2
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78% did not receive subsequent treatment at 2 years in the tafasitamab-cxix + R2 arm (estimated)3
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57% did not receive subsequent treatment at 2 years in the R2 arm (estimated)3
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Time to next treatment was defined as the time from randomization to start of next anti-lymphoma therapy for any reason or death due to any cause, whichever occurs first.3
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Limitations of Analysis
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The decision to initiate subsequent treatment was made by the treating physician and patient and is subject to variability based on investigator interpretation of patient and disease characteristics. The time to next treatment analysis is exploratory in nature and should be interpreted with caution.
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§Kaplan-Meier estimates.2
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| ¶ | Estimated using a stratified Cox proportional hazards model.2 |
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2L+=second-line plus; FL=follicular lymphoma; PFS=progression-free survival; R2=rituximab + lenalidomide; IRC=Independent Review Committee; CI=confidence interval; NE=not evaluable; HR=hazard ratio; TTNT=time to next treatment; NR=not reached.
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IMPORTANT SAFETY INFORMATION
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Warnings and Precautions
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Infusion-Related Reactions
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Tafasitamab-cxix can cause infusion-related reactions (IRRs).
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In inMIND, infusion-related reactions occurred in 16% of the 274
patients with FL who received tafasitamab-cxix in combination with lenalidomide
and rituximab. Signs and symptoms included fever, chills, rash, flushing,
dyspnea, and hypertension. These reactions were generally managed with
temporary interruption of the infusion and/or with supportive medication.
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Premedicate patients prior to starting tafasitamab-cxix infusion. Monitor
patients frequently during infusion. Based on the severity of the
infusion-related reaction, interrupt or discontinue tafasitamab-cxix . Institute
appropriate medical management.
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inMIND Study Design
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The safety and efficacy of tafasitamab-cxix + R2 was studied in inMIND, a Phase 3, double-blind, international, multicenter study of 548 adult patients with relapsed or refractory FL Grade 1, 2, or 3a after at least 1 systemic therapy, including an anti-CD20 antibody. Patients were randomized 1:1 to receive 12 cycles of tafasitamab-cxix + R2 or placebo + R2. The primary endpoint was investigator-assessed PFS using the Lugano criteria.1,4
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IMPORTANT SAFETY INFORMATION
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Contraindications
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None.
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Warnings and Precautions
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Infusion-Related Reactions
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Tafasitamab-cxix can cause infusion-related reactions (IRRs).
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In inMIND, infusion-related reactions occurred in 16% of the 274
patients with FL who received tafasitamab-cxix in combination with lenalidomide
and rituximab. Signs and symptoms included fever, chills, rash, flushing,
dyspnea, and hypertension. These reactions were generally managed with
temporary interruption of the infusion and/or with supportive medication.
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Premedicate patients prior to starting tafasitamab-cxix infusion. Monitor
patients frequently during infusion. Based on the severity of the
infusion-related reaction, interrupt or discontinue Tafasitamab-cxix. Institute
appropriate medical management.
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Myelosuppression
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Tafasitamab-cxix can cause serious or severe myelosuppression, including
neutropenia, lymphopenia, thrombocytopenia, and anemia.
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In inMIND, among 274 patients with FL who received tafasitamab-cxix in
combination with lenalidomide and rituximab, new or worse Grade
3 or 4 cytopenias included decreased neutrophils in 48% (Grade 4, 19%),
decreased lymphocytes in 22% (Grade 4, 1.8%), decreased hemoglobin in 9%,
and decreased platelets in 8% (Grade 4, 4%). Febrile neutropenia
occurred in 4.4%.
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Monitor complete blood counts (CBCs) before each treatment cycle and
throughout treatment. Monitor patients with neutropenia for signs of
infection. Consider granulocyte colony-stimulating factor (G-CSF)
administration. Withhold tafasitamab-cxix based on the severity of the adverse
reaction. Refer to the lenalidomide prescribing information for dosage
modifications.
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Infections
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Fatal and serious infections, including opportunistic infections, occurred
in patients during treatment with tafasitamab-cxix and following the last dose.
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Among 274 patients with FL who received tafasitamab-cxix in combination with
lenalidomide and rituximab in inMIND, Grade 3 or higher infections
occurred in 24%, including fatal infections in 1.1% of patients.
The most frequent Grade ≥ 3 infections were respiratory tract
infections (19%), including Grade 3 or higher pneumonia (14%) and
COVID-19 infection (11%). Opportunistic infections of any grade
occurred in 6% of patients including herpes simplex or zoster
infection (5%), fungal pneumonia (1.1%, including Pneumocystis
jirovecii pneumonia in 0.4%), and cytomegalovirus (CMV)
reactivation (0.4%).
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Monitor patients for signs and symptoms of infection and manage
infections as appropriate. Consider infection prophylaxis per
institutional guidelines. Consider treatment with subcutaneous or
intravenous immunoglobulin (IVIG) as appropriate.
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Embryo-Fetal Toxicity
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Based on its mechanism of action, tafasitamab-cxix may cause fetal B‑cell
depletion when administered to a pregnant woman. Advise pregnant women
of the potential risk to a fetus. Advise women of reproductive potential
to use effective contraception during treatment with tafasitamab-cxix and for
3 months after the last dose.
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The combination of tafasitamab-cxix with lenalidomide and rituximab is
contraindicated in pregnant women because lenalidomide can cause
birth defects and death of the unborn child. Refer to the lenalidomide
prescribing information on use during pregnancy.
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Adverse Reactions
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In the tafasitamab-cxix arm, serious adverse reactions occurred in 33% of
patients, including serious infections in 24% of patients (including
pneumonia and COVID-19 infection). Other serious adverse reactions in
≥ 2% of patients included renal insufficiency (3.3%), second primary
malignancies (2.9%), and febrile neutropenia (2.6%). Fatal adverse
reactions occurred in 1.5% of patients, including from COVID-19,
sepsis, and adenocarcinoma.
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Adverse reactions led to permanent discontinuation of tafasitamab-cxix in 11% of
patients and dosage interruptions in 74%. The most frequent adverse
reactions leading to dosage interruptions of tafasitamab-cxix were neutropenia
(37% of all patients), COVID-19 (22%), pneumonia (11%), and
infusion-related reaction (8%).
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The most common adverse reactions (≥ 20%) in patients receiving tafasitamab-cxix
were respiratory tract infections (56%) (including COVID-19 infection
and pneumonia), diarrhea (38%), rash (37%), fatigue (34%), constipation
(29%), musculoskeletal pain (24%), and cough (21%). The most common
Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils
(48%) and decreased lymphocytes (22%).
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REFERENCES: 1. MONJUVI Prescribing Information.
Wilmington, DE: Incyte Corporation.
2. Sehn L, Luminari S, Scholz C, et al. Tafasitamab
plus lenalidomide and rituximab for relapsed or refractory follicular
lymphoma: results from a phase 3 study (inMIND). Results presented
at: 66th ASH Annual Meeting & Exposition; December 7-10, 2024;
San Diego, CA.
3. Data on file. Incyte Corporation.
4. A phase 3 study to assess efficacy and safety
of tafasitamab plus lenalidomide and rituximab compared to placebo
plus lenalidomide and rituximab in patients with relapsed/refractory
(R/R) follicular lymphoma or marginal zone lymphoma (InMIND).
ClinicalTrials.gov. Accessed
April 4, 2025. https://clinicaltrials.gov/study/NCT04680052
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© 2025, Incyte. MAT-MON-00832 09/25
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