This email is sponsored by Incyte.

Tafasitamab-cxix + R2—‍the first and only CD19- and CD20-targeted immunotherapy combination approved for 2L+ follicular lymphoma patients.¹

Tafasitamab-cxix, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).¹

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.

There was a 59% risk reduction in disease progression or death with tafasitamab-cxix + R2 as assessed by IRC²

IRC-Assessed PFS (Secondary Endpoint): Median PFS was not reached with tafasitamab-cxix + R2 vs 16 months with R2²*

*	PFS by IRC assessment was not formally tested for statistical significance.

SELECT SAFETY INFORMATION

Warnings and Precautions

Infusion-Related Reactions

Tafasitamab-cxix can cause infusion-related reactions (IRRs).

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.

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.

Please see additional Important Safety lnformation below.

Investigator-Assessed PFS (Primary Endpoint)

Median PFS^† 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

•	57% risk reduction in disease progression or death with tafasitamab‍-‍cxix + R2 vs R2

See the 2L+ FL Data

^†‍	Kaplan-Meier estimate.^1,2
^‡‍	Hazard ratio based on a stratified Cox proportional hazards model.^1,2

inMIND Study Design^1,3

inMIND was a Phase 3, double-blind, international, multicenter study of 548 adult patients with R/R 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.

2L+=second-line plus; FL=follicular lymphoma; PFS=progression-free survival; NE=not evaluable; NR=not reached; R2=rituximab and lenalidomide; HR=hazard ratio; CI=confidence interval; IRC=Independent Review Committee; R/R=relapsed/refractory.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Infusion-Related Reactions

Tafasitamab-cxix can cause infusion-related reactions (IRRs).

Myelosuppression

Tafasitamab-cxix can cause serious or severe myelosuppression, including neutropenia, lymphopenia, thrombocytopenia, and anemia.

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%.

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.

Infections

Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with tafasitamab-cxix and following the last dose.

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%‍).

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.

Embryo-Fetal Toxicity

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.

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.

Adverse Reactions

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.

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%).

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%).

Please see the Full Prescribing Information for more information about tafasitamab-cxix.

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. 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. Updated April 4, 2025. Accessed April 8, 2025. ht‍tp‍s‍:‍/‍/‍clinicaltrials‍.‍g‍o‍v/study/NCT04680052

For price transparency information, please click here.

Incyte is committed to maintaining the privacy of your information. To review our Privacy Policy, click here. Please do not reply to this email.

MONJUVI and the MONJUVI logo are registered trademarks of Incyte.
Incyte and the Incyte logo are registered trademarks of Incyte.
© 2025, Incyte. MAT‍-‍MON‍-‍00820 0‍9‍/‍2‍5
1801 Augustine Cut-off, Wilmington, DE 19803

This content is sponsored by Incyte, and ION Oncology Practice Network has not independently reviewed or verified the information provided by Incyte.

This email was sent to karleigh.bard-marsh@cencora.com because you have an account with or are a valued partner of Cencora Specialty GPOs | ION Oncology Practice Network. If you no longer wish to receive these types of emails, please click here to unsubscribe or update your email preferences.