Videos

DR MEHTA: I’m Dr Amitkumar Mehta. I’m joined in this video series by Dr Marin Xavier to talk about 3 different types of adult patients with refractory or relapsed diffuse large B-cell lymphoma who are ineligible for transplant. These patients may be candidates for second- or later-line targeted immunotherapy with MONJUVI plus lenalidomide. MONJUVI is a CD19-directed cytolytic monoclonal antibody.

DR XAVIER: In these videos, we’ll be talking about these hypothetical patients in terms of their treatment goals, patient and disease characteristics, and treatment history. We’ll also see some results from the L-MIND study to get a sense of why MONJUVI, a targeted immunotherapy, may be an appropriate treatment for these patients.

DR XAVIER: In this chapter, we’ll discuss the profile of a hypothetical patient with relapsed or refractory disease and comorbidities.

DR MEHTA: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend tafasitamab-cxix (MONJUVI) in combination with lenalidomide as a preferred second-line or subsequent therapy option for DLBCL in patients who are not candidates for transplant (Category 2A).

DR MEHTA: Before we get into the details of the patient cases, let’s review the indications and usage as well as the warnings and precautions for MONJUVI.

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

NARRATOR: 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 or trials.

NARRATOR: MONJUVI can cause infusion-related reactions. In the L-MIND trial, infusion-related reactions, or IRRs, occurred in 6% of the 81 patients. Eighty percent of the IRRs occurred during cycle 1 or 2. Patients should be premedicated and monitored frequently during their infusion and based on the severity of the IRRs, interrupt or discontinue MONJUVI and institute appropriate medical management.

NARRATOR: In addition, MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Patients’ complete blood counts should be monitored prior to administration of each treatment cycle and throughout treatment. Patients with neutropenia should be monitored for signs of infection and MONJUVI should be withheld based on the severity of the adverse reaction. Consider granulocyte colony-stimulating factor administration. Refer to the lenalidomide prescribing information for dosage modifications.

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported in 2.5% of the 81 patients. Monitor your patients for signs and symptoms of infection and manage as appropriate.

NARRATOR: Because MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman, you should advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

DR MEHTA: Let’s review the case of a patient with relapsed or refractory diffuse large B-cell lymphoma and additional comorbidities. This is probably someone who’s older. But this could also be a younger patient with significant comorbidities. Based on the efficacy results and safety profile demonstrated in the L-MIND study, this is a patient for whom treatment with MONJUVI and lenalidomide may be an appropriate choice.

DR MEHTA: In this hypothetical case, our patient is 75 years old, with an IPI of 2, a lower range of risk. Their ECOG score is 2, and the Ann Arbor stage is 3. They’ve also experienced hypertension, atrial fibrillation, and have a pacemaker.

DR XAVIER: In terms of treatment history, think about someone who’s had 6 cycles of frontline R-mini-CHOP and a negative PET scan, consistent with a complete response following treatment. But they’ve relapsed 2 years after treatment and are now ineligible for autologous stem cell transplant because of their comorbidities. The patient is now looking for tumor reduction.

DR XAVIER: L-MIND was an open-label, multicenter, single-arm phase 2 study of treatment with MONJUVI and lenalidomide. This study included patients with relapsed or refractory DLBCL after 1 to 3 prior systemic therapies, including a CD20-containing therapy. They were not eligible for, or refused, autologous stem cell transplant.

DR MEHTA: The primary endpoint was the best overall response rate, which was defined as the proportion of complete and partial responders. Duration of response was a select secondary endpoint. Efficacy was assessed by an Independent Review Committee using the International Working Group Response Criteria.

DR MEHTA: Patients like the one we just described were well represented in the L-MIND study. Out of the 71 patients that were evaluated for efficacy, nearly 55% of patients were older than 70 and 52% had intermediate-high to high-risk IPI scores of 3 to 5. In addition, about half of the patients had received only 1 prior therapy. Lastly, 18% of patients had atrial fibrillation.

DR MEHTA: 47% of patients were transplant-ineligible because of their age.

DR XAVIER: In the primary analysis, the best overall response rate was 55% at 1 year.

DR MEHTA: MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to potential inclusion of these data in the final, FDA-approved labeling has yet to be determined. This important caveat applies to all the 3-year analyses that we will discuss during this presentation.

DR XAVIER: The best overall response rate was 54% in the 3-year follow-up analysis.

DR XAVIER: In the L-MIND study, the median time to response (partial or complete) was 2 months. The median time to CR was 10.9 months and the median time to PR was 1.9 months.

DR XAVIER: This analysis is exploratory in nature. These results should be interpreted with caution due to single-arm studies not adequately characterizing time-to-event endpoints, and the small sample size, which may lead to estimates that are unstable. Please note that this important caveat applies to all the exploratory analyses that we will discuss during this presentation.

DR MEHTA: Let’s take a look at some more data from the 3-year analysis. We can examine the response rates in patients who were treated with MONJUVI and lenalidomide in the second line, and in the third line or later.

DR MEHTA: In patients who received 1 prior therapy, the best overall response rate was 63%. Of these patients, 43% achieved a complete response, and 20% achieved a partial response. In patients who received 2 or more prior therapies, the best overall response rate was 44%. 28% of these patients achieved a complete response and 17% achieved a partial response.

DR MEHTA: An exploratory analysis was conducted as a part of the 1-year analysis that measured overall response rates by subgroup.

DR XAVIER: This analysis is exploratory in nature, and L-MIND was not designed or powered to evaluate and compare multiple subgroups. These results should be interpreted with caution given the small sample size, which may lead to estimates that are unstable.

DR MEHTA: In this analysis, the overall response rate was 51% in patients over 70 and 62% in those with an IPI of 1 to 2, which is in the low-to-intermediate range.

DR XAVIER: We also saw that patients achieved a 21.7-month median duration of response in the primary analysis and a 43.9-month median duration of response in the 3-year follow-up analysis.

DR MEHTA: This swimmer plot shows the duration of response for each patient who experienced a response during the L-MIND study. Duration of response was captured from the time the initial response began for each patient. This graph represents 38 out of the 71 patients who experienced a response. Two patients started a new anti-cancer treatment immediately after a response was recorded at the end of the treatment assessment. They are still included as responders but did not record any ongoing response with MONJUVI and lenalidomide.

DR MEHTA: For patients whose response has stopped, events may include tumor progression, death, or beginning of a new anti-cancer treatment.

DR MEHTA: The initial assessment of efficacy or disease response was performed and recorded at Cycle 3, Day 1. As you can see, the majority of responding patients, which was 24 out of 38, or 63%, achieved a complete response at some point during this assessment, and nearly 50%, or 11 out of 24 of those complete responses, were observed at the first efficacy assessment (2 months).

DR MEHTA: Orange dots represent the time points when a partial response became a complete response.

DR XAVIER: The fact that 40%, or 16 out of 38 responding patients, either converted from a partial response to a complete response, or maintained an ongoing partial response, shows how important it is for patients to continue treatment with MONJUVI and lenalidomide according to the treatment schedule, as long as there is no disease progression or unacceptable toxicity.

DR XAVIER: As we discussed when reviewing the 3-year follow-up analysis, the median duration of response based on Kaplan-Meier estimates was 43.9 months, demonstrating sustained remission in patients who responded to treatment with MONJUVI + lenalidomide.

DR XAVIER: While this hypothetical patient is older, there could also be younger patients with comorbidities who are ineligible for an autologous stem cell transplant.

DR MEHTA: Yes, I’ve recently had some patients in my practice who fit this profile. Now let’s review some important safety data.

DR MEHTA: The most common adverse reactions in 10% or more of patients are summarized here. The most common hematological adverse reactions were neutropenia, anemia, and thrombocytopenia. 49% of patients had grade 3 or 4 neutropenia, 17% had grade 3 or 4 thrombocytopenia, and 12% of patients had grade 3 or 4 febrile neutropenia.

DR XAVIER: This table summarizes other clinically relevant adverse reactions that occurred in less than 10% of patients in L-MIND. Some adverse reactions to be aware of include lymphopenia (6%), infusion-related reactions (6%), sepsis (4.9%), weight decreased (4.9%), arthralgia (9%), pain in extremity (9%), headache (9%), paresthesia (7%), dysgeusia (6%), nasal congestion (4.9%), and erythema (4.9%).

DR XAVIER: For details about additional clinically relevant adverse reactions, please refer to the full Prescribing Information.

DR MEHTA: In addition, select laboratory abnormalities that worsened from baseline in more than 20% of patients receiving MONJUVI are listed here. Noteworthy laboratory abnormalities include the following: glucose increased in 49% of patients, and grade 3/4 in 5% of patients; gamma glutamyl transferase increased in 34% of patients, and grade 3/4 in 5% of patients; urate increased in 20% of patients, and grade 3/4 in 7% of patients; phosphate decreased in 20% of patients, and grade 3/4 in 5% of patients; and activated partial thromboplastin time increased in 46% of patients, and grade 3/4 in 4.1% of patients.

DR MEHTA: For details about additional laboratory abnormalities, please refer to the full Prescribing Information.

DR XAVIER: Let’s take a look at hematologic toxicity management and dosing modifications in L-MIND. 44% of patients received concomitant granulocyte-colony stimulating factor. 46% of patients had at least 1 dose reduction of lenalidomide. 78% of patients were able to receive a lenalidomide dose of at least 20 milligrams per day over the duration of their treatment.

DR XAVIER: 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%.

DR XAVIER: 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%.

DR XAVIER: MONJUVI balances efficacy with tolerability in patients with relapsed or refractory disease and comorbidities. To learn more about other patients in whom MONJUVI may be an option, please watch the other videos in this series and visit our website at MonjuviHCP.com. Now we will share the Important Safety Information about MONJUVI.

Important Safety Information

NARRATOR: Contraindications

NARRATOR: None.

Warnings and Precautions

Infusion-Related Reactions

NARRATOR: 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

NARRATOR: 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.

NARRATOR: Monitor complete blood counts (CBC) prior to administration of 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

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose.

NARRATOR: 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.

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

Embryo-Fetal Toxicity

NARRATOR: 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.

NARRATOR: 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

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

NARRATOR: Please see the full Prescribing Information for additional Important Safety Information available at MONJUVI.com.

DR MEHTA: Following an assessment of clinical factors, consider targeted immunotherapy with MONJUVI as an option for the second-line treatment of DLBCL in transplant-ineligible patients who want to continue treatment with their current care team, receive outpatient treatment, access treatment in a local office or clinic, and/or receive treatment in a timely manner.

DR XAVIER: On behalf of Dr Mehta, I’m Dr Xavier. Thank you for joining us for this presentation. Be sure to visit MonjuviHCP.com to learn more about treatment with MONJUVI and lenalidomide.

DR MEHTA: I’m Dr Amitkumar Mehta. I’m joined in this video series by Dr Marin Xavier to talk about 3 different types of adult patients with refractory or relapsed diffuse large B-cell lymphoma who are ineligible for transplant. These patients may be candidates for second- or later-line targeted immunotherapy with MONJUVI plus lenalidomide. MONJUVI is a CD19-directed cytolytic monoclonal antibody.

DR XAVIER: In these videos, we’ll be talking about these hypothetical patients in terms of their treatment goals, patient and disease characteristics, and treatment history. We’ll also see some results from the L-MIND study to get a sense of why MONJUVI, a targeted immunotherapy, may be an appropriate treatment for these patients.

DR XAVIER: In this chapter, we’ll be talking about a hypothetical patient with chemorefractory disease.

DR MEHTA: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend tafasitamab-cxix (MONJUVI) in combination with lenalidomide as a preferred second-line or subsequent therapy option for DLBCL in patients who are not candidates for transplant (Category 2A).

DR MEHTA: Before we get into the details of the patient cases, let’s review the indications and usage as well as the warnings and precautions for MONJUVI.

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

NARRATOR: 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 or trials.

NARRATOR: MONJUVI can cause infusion-related reactions. In the L-MIND trial, infusion-related reactions, or IRRs, occurred in 6% of the 81 patients. Eighty percent of the IRRs occurred during cycle 1 or 2. Patients should be premedicated and monitored frequently during their infusion and based on the severity of the IRRs, interrupt or discontinue MONJUVI and institute appropriate medical management.

NARRATOR: In addition, MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Patients’ complete blood counts should be monitored prior to administration of each treatment cycle and throughout treatment. Patients with neutropenia should be monitored for signs of infection and MONJUVI should be withheld based on the severity of the adverse reaction. Consider granulocyte colony-stimulating factor administration. Refer to the lenalidomide prescribing information for dosage modifications.

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported in 2.5% of the 81 patients. Monitor your patients for signs and symptoms of infection and manage as appropriate.

NARRATOR: Because MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman, you should advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

DR XAVIER: Let’s take a look at a patient who is considered chemorefractory, meaning that salvage chemotherapy failed to induce a response. The initial goal was a stem cell transplant. However, salvage high-dose chemotherapy was ineffective and the patient was considered transplant-ineligible. Dr Mehta and I will review why MONJUVI may be a treatment option to consider in this case.

DR XAVIER: This hypothetical patient is 68 years old and has an IPI of 3, which is in the intermediate-high to high risk range, and is at Ann Arbor stage 3. This is a patient who’s minimally restricted by their disease—the ECOG score is 1, but they also have an elevated LDH. They’ve also experienced hypothyroidism. Additional nonclinical considerations are that the patient lives in a rural area and wants to stay local to receive outpatient treatment. Financial considerations are important to this patient.

DR MEHTA: As you mentioned, Dr Xavier, salvage chemotherapy failed to induce a response in this patient. But there are also other complications in terms of treatment history.

DR MEHTA: This hypothetical patient achieved a complete response following R-CHOP, but progressed 6 months after completion of first-line therapy, and has active, bulky disease. Salvage chemotherapy failed to induce a response in this chemorefractory patient, making them ineligible for autologous stem-cell therapy. Their performance status declined to ECOG 2 following chemotherapy.

DR XAVIER: Let’s take a look at the study population in L-MIND, an open-label, multicenter, single-arm phase 2 study of treatment with MONJUVI and lenalidomide. You’ll recognize many of the patient characteristics we just mentioned.

DR XAVIER: L-MIND included patients with relapsed or refractory diffuse large B-cell lymphoma after 1 to 3 prior systemic therapies, including a CD20-containing therapy. They were not eligible for, or refused, autologous stem cell transplant.

DR MEHTA: The primary endpoint was the best overall response rate, which was defined as the proportion of complete and partial responders. Duration of response was a select secondary endpoint. Efficacy was assessed by an Independent Review Committee using the International Working Group Response Criteria.

DR MEHTA: Patients like the one we just described were well represented in the L-MIND study. Out of the 71 patients that were evaluated for efficacy, 27% of patients were refractory to salvage chemotherapy or showed no response to salvage chemo. 52% had IPI scores of 3 to 5, which are in the intermediate-high to high-risk range. 45% were refractory to their last prior therapy, and 24% experienced relapse or progression within 12 months of their first DLBCL diagnosis.

DR MEHTA: The study included a sizable proportion of patients with characteristics considered difficult-to-treat. And the data that follows shows that these patients may be appropriate candidates for treatment with MONJUVI.

DR XAVIER: In the primary analysis, the best overall response rate was 55% at 1 year.

DR MEHTA: MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to potential inclusion of these data in the final, FDA-approved labeling has yet to be determined. This important caveat applies to all the 3-year analyses that we will discuss during this presentation.

DR XAVIER: The best overall response rate was 54% in the 3-year follow-up analysis.

DR XAVIER: In the L-MIND study, the median time to response (partial or complete) was 2 months. The median time to CR was 10.9 months and the median time to PR was 1.9 months.

DR XAVIER: This analysis is exploratory in nature. These results should be interpreted with caution due to single-arm studies not adequately characterizing time-to-event endpoints, and the small sample size, which may lead to estimates that are unstable. Please note that this important caveat applies to all the exploratory analyses that we will discuss during this presentation.

DR MEHTA: Let’s take a look at some more data from the 3-year analysis. We can examine the response rates in patients who were treated with MONJUVI and lenalidomide in the second line, and in the third line or later.

DR MEHTA: In patients who received 1 prior therapy, the best overall response rate was 63%. Of these patients, 43% achieved a complete response, and 20% achieved a partial response. In patients who received 2 or more prior therapies, the best overall response rate was 44%. 28% of these patients achieved a complete response and 17% achieved a partial response.

DR MEHTA: An exploratory analysis was conducted as a part of the 1-year analysis that measured overall response rates by subgroup.

DR XAVIER: This analysis is exploratory in nature, and L-MIND was not designed or powered to evaluate and compare multiple subgroups. These results should be interpreted with caution given the small sample size, which may lead to estimates that are unstable.

DR MEHTA: In this analysis, the overall response rate was 53% for patients with elevated LDH, 56% for patients with Ann Arbor stage 3 to 4 disease, and 49% for patients with an intermediate-high to high-risk IPI score in the 3 to 5 range.

DR XAVIER: We also saw that patients achieved a 21.7-month median duration of response in the primary analysis and a 43.9-month median duration of response in the 3-year follow-up analysis.

DR MEHTA: This swimmer plot shows the duration of response for each patient who experienced a response during the L-MIND study. Duration of response was captured from the time the initial response began for each patient. This graph represents 38 out of the 71 patients who experienced a response. Two patients started a new anti-cancer treatment immediately after a response was recorded at the end of the treatment assessment. They are still included as responders but did not record any ongoing response with MONJUVI and lenalidomide.

DR MEHTA: For patients whose response has stopped, events may include tumor progression, death, or beginning of a new anti-cancer treatment.

DR MEHTA: The initial assessment of efficacy or disease response was performed and recorded at Cycle 3, Day 1. As you can see, the majority of responding patients, which was 24 out of 38, or 63%, achieved a complete response at some point during this assessment, and nearly 50%, or 11 out of 24 of those complete responses, were observed at the first efficacy assessment (2 months).

DR MEHTA: Orange dots represent the time points when a partial response became a complete response.

DR XAVIER: The fact that 40%, or 16 out of 38 responding patients, either converted from a partial response to a complete response, or maintained an ongoing partial response, shows how important it is for patients to continue treatment with MONJUVI and lenalidomide according to the treatment schedule, as long as there is no disease progression or unacceptable toxicity.

DR XAVIER: As we discussed when reviewing the 3-year follow-up analysis, the median duration of response based on Kaplan-Meier estimates was 43.9 months, demonstrating sustained remission in patients who responded to treatment with MONJUVI + lenalidomide.

DR XAVIER: MONJUVI is targeted immunotherapy for adult patients with DLBCL who have received at least 1 prior therapy, in combination with lenalidomide. MONJUVI is a potential treatment option for patients who are transplant-ineligible, and who did not respond to salvage chemotherapy. Now let’s review some important safety data.

DR MEHTA: The most common adverse reactions in 10% or more of patients are summarized here. The most common hematological adverse reactions were neutropenia, anemia, and thrombocytopenia. 49% of patients had grade 3 or 4 neutropenia, 17% had grade 3 or 4 thrombocytopenia, and 12% of patients had grade 3 or 4 febrile neutropenia.

DR XAVIER: This table summarizes other clinically relevant adverse reactions that occurred in less than 10% of patients in L-MIND. Some adverse reactions to be aware of include lymphopenia (6%), infusion-related reactions (6%), sepsis (4.9%), weight decreased (4.9%), arthralgia (9%), pain in extremity (9%), headache (9%), paresthesia (7%), dysgeusia (6%), nasal congestion (4.9%), and erythema (4.9%).

DR XAVIER: For details about additional clinically relevant adverse reactions, please refer to the full Prescribing Information.

DR MEHTA: In addition, select laboratory abnormalities that worsened from baseline in more than 20% of patients receiving MONJUVI are listed here. Noteworthy laboratory abnormalities include the following: glucose increased in 49% of patients, and grade 3/4 in 5% of patients; gamma glutamyl transferase increased in 34% of patients, and grade 3/4 in 5% of patients; urate increased in 20% of patients, and grade 3/4 in 7% of patients; phosphate decreased in 20% of patients, and grade 3/4 in 5% of patients; and activated partial thromboplastin time increased in 46% of patients, and grade 3/4 in 4.1% of patients.

DR MEHTA: For details about additional laboratory abnormalities, please refer to the full Prescribing Information.

DR XAVIER: Let’s take a look at hematologic toxicity management and dosing modifications in L-MIND. 44% of patients received concomitant granulocyte-colony stimulating factor. 46% of patients had at least 1 dose reduction of lenalidomide. 78% of patients were able to receive a lenalidomide dose of at least 20 milligrams per day over the duration of their treatment.

DR XAVIER: 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%.

DR XAVIER: 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%.

DR XAVIER: MONJUVI offers a balance of efficacy and tolerability for patients with chemorefractory disease. To learn more about other patients in whom MONJUVI may be an option, please watch the other videos in this series and visit our website at MonjuviHCP.com. Now we will share the Important Safety Information about MONJUVI.

Important Safety Information

NARRATOR: Contraindications

NARRATOR: None.

Warnings and Precautions

Infusion-Related Reactions

NARRATOR: 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

NARRATOR: 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.

NARRATOR: Monitor complete blood counts (CBC) prior to administration of 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

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose.

NARRATOR: 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.

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

Embryo-Fetal Toxicity

NARRATOR: 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.

NARRATOR: 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

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

NARRATOR: Please see the full Prescribing Information for additional Important Safety Information available at MONJUVI.com.

DR MEHTA: Following an assessment of clinical factors, consider targeted immunotherapy with MONJUVI as an option for the second-line treatment of DLBCL in transplant-ineligible patients who want to continue treatment with their current care team, receive outpatient treatment, access treatment in a local office or clinic, and/or receive treatment in a timely manner.

DR XAVIER: On behalf of Dr Mehta, I’m Dr Xavier. Thank you for joining us for this presentation. Be sure to visit MonjuviHCP.com to learn more about treatment with MONJUVI and lenalidomide.

DR MEHTA: I’m Dr Amitkumar Mehta. I’m joined in this video series by Dr Marin Xavier to talk about 3 different types of adult patients with refractory or relapsed diffuse large B-cell lymphoma who are ineligible for transplant. These patients may be candidates for second- or later-line targeted immunotherapy with MONJUVI plus lenalidomide. MONJUVI is a CD19-directed cytolytic monoclonal antibody.

DR XAVIER: In these videos, we’ll be talking about these hypothetical patients in terms of their treatment goals, patient and disease characteristics, and treatment history. We’ll also see some results from the L-MIND study to get a sense of why MONJUVI, a targeted immunotherapy, may be an appropriate treatment for these patients.

DR XAVIER: In this chapter, we’ll be reviewing the hypothetical case of a patient whose disease progressed within 12 months of their initial diagnosis and who wants to receive treatment in their local area from their current care team.

DR MEHTA: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend tafasitamab-cxix (MONJUVI) in combination with lenalidomide as a preferred second-line or subsequent therapy option for DLBCL in patients who are not candidates for transplant (Category 2A).

DR MEHTA: Before we get into the details of the patient cases, let’s review the indications and usage as well as the warnings and precautions for MONJUVI.

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

NARRATOR: 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 or trials.

NARRATOR: MONJUVI can cause infusion-related reactions. In the L-MIND trial, infusion-related reactions, or IRRs, occurred in 6% of the 81 patients. Eighty percent of the IRRs occurred during cycle 1 or 2. Patients should be premedicated and monitored frequently during their infusion and based on the severity of the IRRs, interrupt or discontinue MONJUVI and institute appropriate medical management.

NARRATOR: In addition, MONJUVI can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Patients’ complete blood counts should be monitored prior to administration of each treatment cycle and throughout treatment. Patients with neutropenia should be monitored for signs of infection and MONJUVI should be withheld based on the severity of the adverse reaction. Consider granulocyte colony-stimulating factor administration. Refer to the lenalidomide prescribing information for dosage modifications.

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose. 73% of the 81 patients developed an infection. The most frequent infections were respiratory tract infection, urinary tract infection, bronchitis, nasopharyngitis and pneumonia. Grade 3 or higher infection occurred in 30% of the 81 patients. The most frequent grade 3 or higher infection was pneumonia. Infection-related deaths were reported in 2.5% of the 81 patients. Monitor your patients for signs and symptoms of infection and manage as appropriate.

NARRATOR: Because MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman, you should advise pregnant women of the potential risk to a fetus, and advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose. The combination of MONJUVI with lenalidomide is contraindicated in pregnant women. Refer to the lenalidomide prescribing information on use during pregnancy.

DR MEHTA: In this case, the patient's disease progressed within 12 months of their diagnosis and they want to stay in their local area to receive treatment. Their disease has progressed quickly, despite initial treatment with CD20-containing therapy, so the goal is to stop or slow its progression and time is of the essence. This patient doesn’t have a support system to rely on, so their preference is to stay with their current healthcare team.

DR MEHTA: The physician intends to initiate therapy immediately for this patient, with the goal of achieving a sustained response. Let’s take a look at why MONJUVI may be a suitable option for a patient like this one.

DR MEHTA: In our hypothetical example, the patient is 65 years old, has an intermediate-high to high risk IPI of 3, ECOG of 1, and is at Ann Arbor stage 3. They’ve also experienced hypertension and they are eager to initiate treatment.

DR MEHTA: The treatment history for our hypothetical patient looks like this:

• After 4 cycles of R-CHOP, they achieved a PR, which was maintained through the completion of first-line therapy
• Their disease progressed after a quick relapse—4 months following first-line therapy
• and they declined autologous stem cell transplant based on their lack of a support system and their preference to stay with their current care team, but are still seeking further treatment

DR XAVIER: After previously receiving R-CHOP, the patient may not want to pursue salvage chemotherapy. MONJUVI is an option that may be appropriate for this patient.

DR XAVIER: MONJUVI is a targeted immunotherapy for adult patients with DLBCL who have received at least 1 prior therapy, in combination with lenalidomide.

DR MEHTA: Let’s take a look at some key data from L-MIND, an open-label, multicenter, single-arm phase 2 study of treatment with MONJUVI and lenalidomide.

DR XAVIER: L-MIND included patients with relapsed or refractory DLBCL after 1 to 3 prior systemic therapies, including a CD20-containing therapy. They were not eligible for, or refused, autologous stem cell transplant.

DR XAVIER: Primary refractory patients were defined in L-MIND as those whose DLBCL relapsed or progressed after at least 3 months from completion of prior CD20-containing therapy. The study included only patients who met this definition.

DR MEHTA: The primary endpoint was the best overall response rate, which was defined as the proportion of complete and partial responders. Duration of response was a select secondary endpoint. Efficacy was assessed by an Independent Review Committee using the International Working Group Response Criteria.

DR MEHTA: Patients like the one we just described were well represented in the L-MIND study. Out of the 71 patients that were evaluated for efficacy, 20% had primary refractory disease, 45% were refractory to their last prior therapy, and 42% were refractory to rituximab.

DR MEHTA: Also, 24% of patients had relapsed or progressed within the first 12 months after initial diagnosis. Lastly, 52% had IPI scores of 3 to 5, which are in the intermediate-high to high-risk range.

DR XAVIER: In the primary analysis, the best overall response rate was 55% at 1 year.

DR MEHTA: MONJUVI, in combination with lenalidomide, was granted accelerated approval based on the 1-year primary analysis of the L-MIND study. The data for the 3-year analysis of the L-MIND study has not yet been submitted to or reviewed by the FDA. The status with respect to potential inclusion of these data in the final, FDA-approved labeling has yet to be determined. This important caveat applies to all the 3-year analyses that we will discuss during this presentation.

DR XAVIER: The best overall response rate was 54% in the 3-year follow-up analysis.

DR XAVIER: In the L-MIND study, the median time to response (partial or complete) was 2 months. The median time to CR was 10.9 months and the median time to PR was 1.9 months.

DR XAVIER: This analysis is exploratory in nature. These results should be interpreted with caution due to single-arm studies not adequately characterizing time-to-event endpoints, and the small sample size, which may lead to estimates that are unstable. Please note that this important caveat applies to all the exploratory analyses that we will discuss during this presentation.

DR MEHTA: Let’s take a look at some more data from the 3-year analysis. We can examine the response rates in patients who were treated with MONJUVI and lenalidomide in the second line, and in the third line or later.

DR MEHTA: In patients who received 1 prior therapy, the best overall response rate was 63%. Of these patients, 43% achieved a complete response, and 20% achieved a partial response. In patients who received 2 or more prior therapies, the best overall response rate was 44%. 28% of these patients achieved a complete response and 17% achieved a partial response.

DR MEHTA: An exploratory analysis was conducted as a part of the 1-year analysis that measured overall response rates by subgroup.

DR XAVIER: This analysis is exploratory in nature, and L-MIND was not designed or powered to evaluate and compare multiple subgroups. These results should be interpreted with caution given the small sample size, which may lead to estimates that are unstable.

DR MEHTA: 53% of patients whose disease was refractory to the prior line of therapy achieved an overall response, as did 50% of those who were refractory to rituximab, 49% of those with an intermediate-high to high-risk IPI score of 3 to 5, and 56% with Ann Arbor stage 3 to 4 disease.

DR XAVIER: We also saw that patients achieved a 21.7-month median duration of response in the primary analysis and a 43.9-month median duration of response in the 3-year follow-up analysis.

DR MEHTA: This swimmer plot shows the duration of response for each patient who experienced a response during the L-MIND study. Duration of response was captured from the time the initial response began for each patient. This graph represents 38 out of the 71 patients who experienced a response. Two patients started a new anti-cancer treatment immediately after a response was recorded at the end of the treatment assessment. They are still included as responders but did not record any ongoing response with MONJUVI and lenalidomide.

DR MEHTA: For patients whose response has stopped, events may include tumor progression, death, or beginning of a new anti-cancer treatment.

DR MEHTA: The initial assessment of efficacy or disease response was performed and recorded at Cycle 3, Day 1. As you can see, the majority of responding patients, which was 24 out of 38, or 63%, achieved a complete response at some point during this assessment, and nearly 50%, or 11 out of 24 of those complete responses, were observed at the first efficacy assessment (2 months).

DR MEHTA: Orange dots represent the time points when a partial response became a complete response.

DR XAVIER: The fact that 40%, or 16 out of 38 responding patients, either converted from a partial response to a complete response, or maintained an ongoing partial response, shows how important it is for patients to continue treatment with MONJUVI and lenalidomide according to the treatment schedule, as long as there is no disease progression or unacceptable toxicity.

DR XAVIER: As we discussed when reviewing the 3-year follow-up analysis, the median duration of response based on Kaplan-Meier estimates was 43.9 months, demonstrating sustained remission in patients who responded to treatment with MONJUVI + lenalidomide.

DR XAVIER: MONJUVI is a potential option for this patient, whose disease progressed within the first year after diagnosis and who wants to stay in their local area to receive treatment from their current care team.

DR XAVIER: Now let’s review some important safety data.

DR MEHTA: The most common adverse reactions in 10% or more of patients are summarized here. The most common hematological adverse reactions were neutropenia, anemia, and thrombocytopenia. 49% of patients had grade 3 or 4 neutropenia, 17% had grade 3 or 4 thrombocytopenia, and 12% of patients had grade 3 or 4 febrile neutropenia.

DR XAVIER: This table summarizes other clinically relevant adverse reactions that occurred in less than 10% of patients in L-MIND. Some adverse reactions to be aware of include lymphopenia (6%), infusion-related reactions (6%), sepsis (4.9%), weight decreased (4.9%), arthralgia (9%), pain in extremity (9%), headache (9%), paresthesia (7%), dysgeusia (6%), nasal congestion (4.9%), and erythema (4.9%).

DR XAVIER: For details about additional clinically relevant adverse reactions, please refer to the full Prescribing Information.

DR MEHTA: In addition, select laboratory abnormalities that worsened from baseline in more than 20% of patients receiving MONJUVI are listed here. Noteworthy laboratory abnormalities include the following: glucose increased in 49% of patients, and grade 3/4 in 5% of patients; gamma glutamyl transferase increased in 34% of patients, and grade 3/4 in 5% of patients; urate increased in 20% of patients, and grade 3/4 in 7% of patients; phosphate decreased in 20% of patients, and grade 3/4 in 5% of patients; and activated partial thromboplastin time increased in 46% of patients, and grade 3/4 in 4.1% of patients.

DR MEHTA: For details about additional laboratory abnormalities, please refer to the full Prescribing Information.

DR XAVIER: Let’s take a look at hematologic toxicity management and dosing modifications in L-MIND. 44% of patients received concomitant granulocyte-colony stimulating factor. 46% of patients had at least 1 dose reduction of lenalidomide. 78% of patients were able to receive a lenalidomide dose of at least 20 milligrams per day over the duration of their treatment.

DR XAVIER: 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%.

DR XAVIER: 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%.

DR XAVIER: For this patient, whose disease progressed within 12 months of their initial diagnosis and who wants to stay in their local area to receive treatment from their current care team, MONJUVI provides an important balance between efficacy and tolerability. To learn more about other patients in whom MONJUVI may be an option, please watch the other videos in this series and visit our website at MonjuviHCP.com. Now we will share the Important Safety Information about MONJUVI.

Important Safety Information

NARRATOR: Contraindications

NARRATOR: None.

Warnings and Precautions

Infusion-Related Reactions

NARRATOR: 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

NARRATOR: 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.

NARRATOR: Monitor complete blood counts (CBC) prior to administration of 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

NARRATOR: Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose.

NARRATOR: 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.

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

Embryo-Fetal Toxicity

NARRATOR: 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.

NARRATOR: 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

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: 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%).

NARRATOR: You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

NARRATOR: Please see the full Prescribing Information for additional Important Safety Information available at MONJUVI.com.

DR MEHTA: Following an assessment of clinical factors, consider targeted immunotherapy with MONJUVI as an option for the second-line treatment of DLBCL in transplant-ineligible patients who want to continue treatment with their current care team, receive outpatient treatment, access treatment in a local office or clinic, and/or receive treatment in a timely manner.

DR XAVIER: On behalf of Dr Mehta, I’m Dr Xavier. Thank you for joining us for this presentation. Be sure to visit MonjuviHCP.com to learn more about treatment with MONJUVI and lenalidomide.