This email is sponsored by Incyte.

MONJUVI is the only outpatient targeted immunotherapy for adult NTE patients with R/R DLBCL in 2L with 5-year data.^1,2*

MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The 5-year analysis data from L-MIND have not been submitted to or reviewed by the FDA, and potential inclusion of these data in the final FDA-approved labeling has yet to be determined.

1-year primary analysis in patients with R‍/‍R DLBCL (N=71)^1†:

►	Best ORR: 55% (n=39; 95% CI: 43%, 67%); CR: 37%; PR: 18%
►	Median DoR: 21.7 months (range: 0, 24)^‡

5-year follow-up analysis^3†

►	Best ORR: 54% (n=38; 95% Cl: 41%, 66%); CR: 37%; PR: 17%

Median DoR: 5-Year Follow-Up^3,4

Median DoR not reached^†‡ (median follow-up: 53.8 months [95% CI: 31.8-58.7])

Approximately 57% of responding patients were still in remission at 5 years (95% CI: 37%, 72%)^3,4§

See 5-year data

L-MIND STUDY
L-MIND was an open-label, multicenter, single‍-‍arm, Phase 2 study that evaluated the efficacy and safety of MONJUVI in combination with lenalidomide followed by MONJUVI monotherapy in adult patients with R‍/‍R DLBCL after 1 to 3 prior systemic DLBCL therapies, including a CD20-containing therapy.^1,5 The median number of prior therapies was 2.¹ Enrolled patients at the time of the study were not eligible for or refused ASCT.^1,5 Efficacy was established in 71 patients with DLBCL (confirmed by central laboratory) based on best ORR (CR + PR) and DoR, as assessed by an Independent Review Committee using the International Working Group Response Criteria (Cheson 2007).¹

*	MONJUVI is a CD19-directed cytolytic monoclonal antibody.¹
^†‍	Assessed by an Independent Review Committee.^1,2
^‡‍	Kaplan-Meier estimates.^1,3
^§‍	DoR rate at 5 years is a Kaplan-Meier estimate and should be interpreted with caution due to the small sample size and the number of censored patients.
	The cutoff date for the primary analysis was November 30, 2018, and occurred after the last patient enrolled had completed 12 months of follow-up. The cutoff date for the 5-year follow-up analysis was November 14, 2022, and occurred after the last patient enrolled had completed 5 years of follow-up.^2,4
	2L=second line; DLBCL=diffuse large B-cell lymphoma; NTE=non-transplant eligible; R/R=relapsed/refractory; ORR=overall response rate; CI=confidence interval; CR=complete response rate; PR=partial response rate; DoR=duration of response; ASCT=autologous stem cell transplant.

INDICATIONS & USAGE MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION
Contraindications
None.
Warnings and Precautions
Infusion-Related Reactions
MONJUVI can cause infusion-related reactions (IRRs). In L-MIND, infusion-related reactions occurred in 6% of the 81 patients. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion. Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI. Institute appropriate medical management.

Myelosuppression
MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. In L-MIND, Grade 3 neutropenia occurred in 25% of patients, thrombocytopenia in 12%‍, and anemia in 7%. Grade 4 neutropenia occurred in 25% and thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of patients.

Monitor complete blood counts (CBC) prior to administration of each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection.

Continued below.

IMPORTANT SAFETY INFORMATION (continued)

Warnings and Precautions (continued)

Myelosuppression (continued)

Consider granulocyte colony-stimulating factor (G‑CSF) administration. Withhold MONJUVI 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 MONJUVI and following the last dose.

In L-MIND, 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection (24%), urinary tract infection (17%), bronchitis (16%), nasopharyngitis (10%) and pneumonia (10%). Grade 3 or higher infection occurred i‍n 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia (7%). Infection-related deaths were reported in 2.5% of the 81 patients.

Monitor patients for signs and symptoms of infection and manage infections as appropriate.

Embryo-Fetal Toxicity

Based on its mechanism of action, MONJUVI 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 MONJUVI and for at least 3 months after the last dose.

MONJUVI is initially administered in combination with lenalidomide. The combination of MONJUVI with lenalidomide 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

Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%).

Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%).

The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).

Please see the Full Prescribing Information.

REFERENCES: 1. MONJUVI Prescribing Information. Wilmington, DE. Incyte Corporation. 2. Duell J, Abrisqueta P, Andre M, et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024;109(2):553-566. doi:10.3324/haematol.2023‍.‍283‍48‍0 3. Duell J, Abrisqueta P, Andre M, et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 20‍24;10‍9(2)(Suppl):553‍-‍566. doi:1‍0.3‍3‍24/haematol.20‍23.283‍480 4. Data on file. Incyte Corporation. 5. ClinicalTrials‍.‍gov. A study to evaluate the safety and efficacy of lenalidomide with MOR00208 in patients with R-R DLBCL (L-MIND). ht‍tp‍s‍:‍/‍/‍clinicaltrials‍.‍g‍o‍v/‌study/NCT02399085. Accessed January 28, 2025.

For price transparency information, please click here.

Incyte Corporation 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-00530 0‍2‍/‍2‍5
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.