Trust is especially important when supporting patients living with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma.¹ While survival rates have improved over the past several decades, 20% to 50% of patients with DLBCL will be refractory to standard first-line treatment or relapse after achieving complete response.² Faced with the unknowns of how they may respond, patients’ second-line treatment needs and preferences can vary significantly based on their lifestyle, support network, and geographic location. With so many factors to consider, a foundation of trust is essential for providers to ensure their patients are not just recipients of care, but active participants who feel fully supported and heard throughout their treatment journey.

Understanding Patient Needs

Before diving into treatment discussions, I believe it's crucial to understand a patient’s goals and lifestyle. Beyond clinical factors such as age, medical comorbidities, and disease severity, I often ask patients to share information about their interests and daily lives.

In these conversations, I gain crucial insights that can impact treatment recommendations. For instance, many of my patients live in remote areas, such as the farmers I treat. Some express concerns about their ability to travel or live elsewhere for part of the year to receive treatment. Most are concerned about spending time with loved ones and friends. The existence and availability of caregiver support as well as financial considerations are also key factors in the shared decision-making process.

Each of these concerns is valid and very individual. Knowing and considering a patient’s personal situation aids both in building trust and open communication and also in easing their journey as much as possible. This is particularly important when the emotional toll is high, as is the case for many patients at this stage of their journey with DLBCL, when their aggressive cancer has not responded to treatment or has relapsed after first- or even second-line therapies.

Offering Diverse Treatment Options

With these personal considerations in mind, providers can begin to outline a treatment plan to meet each patient’s unique needs. In the evolving DLBCL landscape, providers have an expanding range of treatment options to consider with their patients, including chimeric antigen receptor (CAR) T-cell therapy and autologous stem-cell transplant (ASCT), both of which are administered in the hospital setting. There are also targeted nonchemotherapy approaches available that can be administered in the community setting, such as targeted immunotherapy.

One example is MONJUVI® (tafasitamab-cxix). MONJUVI in combination with lenalidomide is indicated for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for 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).³

MONJUVI combined with lenalidomide is an outpatient, non-chemotherapy option that has shown promising results and has 5-year follow-up data in relapsed/refractory DLBCL patients who are not eligible for ASCT.^3,4 MONJUVI was granted accelerated approval by the U.S. Food & Drug Administration (FDA) 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 the potential inclusion of these data in the final FDA-approved labeling has yet to be determined.

MONJUVI can cause serious adverse reactions including infusion-related reactions, myelosuppression, infections, and embryo-fetal toxicity. 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%).³

With an array of good options for relapsed or refractory patients, we can develop treatment plans that consider each patient’s unique lifestyle priorities while addressing their DLBCL.

Shared Decision-Making, Shared Journey

I believe the most important thing we can do as providers is acknowledge these are not our journeys. We cannot expect to walk into a room and tell a patient what to do. Instead, we need to ask questions, get them involved in the decisions and join the patients on their journey. I believe that it is our job to provide our patients all the information and help them navigate it, putting their needs first.

Through shared decision-making, patients will feel empowered to ask questions, explore their options, and feel actively involved in decisions about their treatment. This involvement fosters trust and can also help to ease nerves.

While decision-making conversations can be complex, especially as treatment options progress, I’m a firm believer that these conversations and connections serve our patients by making cancer care more inclusive and compassionate.

To learn more about MONJUVI and relapsed or refractory DLBCL and find support and resources, visit www.MONJUVIhcp.com.

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

In L-MIND, infusion-related reactions occurred in 6% of the 81 patients with DLBCL who received MONJUVI. 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 generally 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, lymphopenia, thrombocytopenia, and anemia.

In L-MIND, among 81 patients with DLBCL who received MONJUVI, Grade 3 neutropenia was reported in 25%, Grade 3 thrombocytopenia in 12%, and Grade 3 anemia in 7%. Grade 4 neutropenia was reported in 25% and Grade 4 thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of the patients. Febrile neutropenia occurred in 12%.

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 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 with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. Infection-related deaths occurred in 2.5% of patients, including a case of progressive multifocal leukoencephalopathy (PML). The most frequent Grade 3 or higher infection was pneumonia (7%). The most frequent infections of any grade were respiratory tract infections (51%, including pneumonias) and urinary tract infection (17%).

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, 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 3 months after the last dose.

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%), and 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%), respiratory tract infection (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), and decreased appetite (22%).

Please see the Full Prescribing Information for more information about MONJUVI.

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