MONJUVI
Generic: TAFASITAMAB-CXIX
Basic Information
Manufacturer
Incyte Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9e0a220b-517f-4c86-b581-ffbab493fb58
Indications & Usage
1 INDICATIONS AND USAGE MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide 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).
( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
( 1.2 ) Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
( 1.2 , 14.3 ) 1.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma MONJUVI, 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 [ see Clinical Studies ( 14.1 )] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
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).
( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
( 1.2 ) Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
( 1.2 , 14.3 ) 1.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma MONJUVI, 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 [ see Clinical Studies ( 14.1 )] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Infections [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 20%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
( 6.1 ) The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes.
To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Diffuse Large B-cell Lymphoma The safety of MONJUVI in patients with relapsed or refractory DLBCL was evaluated in L-MIND [see Clinical Studies ( 14 .1 )].
Patients (N = 81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle; Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle; Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.
Among patients who received MONJUVI, 57% were exposed for 6 months or longer, 42% were exposed for greater than one year, and 24% were exposed for greater than two years.
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 interruptions 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, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
Table 4 summarizes the adverse reactions in L-MIND.
Table 4: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Adverse Reaction MONJUVI in Combination with Lenalidomide (N = 81) All Grades (%) Grade 3 or 4 (%) Blood and lymphatic system disorders Neutropenia 51 49 Anemia 36 7 Thrombocytopenia 31 17 Febrile neutropenia 12 12 Infections Respiratory tract infection Respiratory tract infection includes lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection, bronchitis, pneumonia, nasopharyngitis, and related terms.
51 12 Urinary tract infection Urinary tract infection includes urinary tract infection, urinary tract infection bacterial, and related terms.
17 4.9 General disorders and administration site conditions Fatigue Fatigue includes asthenia and fatigue.
38 3.7 Pyrexia 24 1.2 Peripheral edema 24 0 Gastrointestinal disorders Diarrhea 36 1.2 Constipation 17 0 Abdominal pain Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper.
15 1.2 Nausea 15 0 Vomiting 15 0 Respiratory, thoracic and mediastinal disorders Cough 26 1.2 Dyspnea 12 1.2 Metabolism and nutrition disorders Decreased appetite 22 0 Hypokalemia 19 6 Musculoskeletal and connective tissue disorders Back pain 19 2.5 Muscle spasms 15 0 Skin and subcutaneous tissue disorders Rash Rash includes rash, rash maculopapular, rash pruritic, rash erythematous, and rash pustular.
15 2.5 Pruritus 10 1.2 Clinically relevant adverse reactions in < 10% of patients with relapsed or refractory DLBCL who received MONJUVI in L-MIND were: Blood and lymphatic system disorders: lymphopenia (6%) General disorders and administration site conditions: infusion-related reaction (6%) Infections: sepsis (4.9%) Investigations: weight decreased (4.9%) Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%) Neoplasms: basal cell carcinoma (1.2%) Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%) Respiratory, thoracic and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%) Skin and subcutaneous tissue disorders: erythema (4.9%), alopecia (2.5%), hyperhidrosis (2.5%) Table 5 summarizes the laboratory abnormalities in L-MIND.
Table 5: Select Laboratory Abnormalities (≥ 20%) Worsening from Baseline in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value.
All Grades (%) Grade 3 or 4 (%) Chemistry Glucose increased 49 5 Calcium decreased 47 1.4 Gamma glutamyl transferase increased 34 5 Albumin decreased 26 0 Magnesium decreased 22 0 Urate increased 20 7 Phosphate decreased 20 5 Creatinine increased 20 1.4 Aspartate aminotransferase increased 20 0 Coagulation Activated partial thromboplastin time increased 46 4.1 Relapsed or Refractory Follicular Lymphoma The safety of MONJUVI in patients with relapsed or refractory FL was evaluated in the inMIND trial [see Clinical Studies (14.2)].
Patients received MONJUVI 12 mg/kg (N = 274) or placebo (N = 272) intravenously for a maximum of 12 cycles in combination with lenalidomide 20 mg (Days 1-21 of Cycles 1 to 12) and rituximab 375 mg/m 2 (Cycles 1 to 5).
MONJUVI was administered as follows: Cycle 1 to 3: Days 1, 8, 15, and 22 of each 28-day cycle; Cycles 4 to 12: Days 1 and 15 of each 28-day cycle.
In the MONJUVI arm, 54% of patients completed all 12 cycles.
The median age in that arm was 64 years (range: 36-88 years); 20% were age 75 years or older; 55% were male; 80% were White, 15% Asian, and 0.4% Black.
In the MONJUVI 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 MONJUVI in 11% of patients and dosage interruptions in 74%.
The most frequent adverse reactions leading to dosage interruptions of MONJUVI were neutropenia (37% of all patients), COVID-19 (22%), pneumonia (11%), and infusion-related reaction (8%).
The most common adverse reactions (≥ 20%) in recipients of MONJUVI, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.
Table 6 summarizes the adverse reactions in inMIND.
Adverse reactions occurring at least 5% more frequently in the MONJUVI arm included COVID-19 infection, pneumonia, diarrhea, pruritus, fatigue, musculoskeletal pain, and mucositis.
Table 6: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Adverse Reaction MONJUVI in Combination with Lenalidomide and Rituximab (N = 274) Placebo in Combination with Lenalidomide and Rituximab (N = 272) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Infections Respiratory tract infection 56 18 56 9 COVID-19 infection Includes COVID-19, COVID-19 pneumonia, and coronavirus test positive.
34 Includes 2 cases in each arm with fatal outcome.
10 24 2.9 Pneumonia Includes pneumonia, COVID-19 pneumonia, pneumonia fungal, Pneumocystis jirovecii pneumonia, and other types of pneumonia.
18 14 11 Includes 3 cases with fatal outcome, including 2 reported under COVID-19 infection.
7 Upper respiratory tract infection Includes upper respiratory tract infection, nasopharyngitis, sinusitis, laryngitis, and related terms.
17 1.1 22 0.4 Gastrointestinal disorders Diarrhea 38 0.7 28 1.8 Constipation 29 0.7 25 0 Nausea 18 0.4 14 0.4 Abdominal pain 13 0 18 2.2 Skin and subcutaneous tissue disorders Rash Includes rash, urticaria, dermatitis, drug eruption, and related terms.
37 3.6 33 1.5 Pruritus 16 0.4 10 0 General disorders Fatigue Includes fatigue and asthenia.
34 2.9 25 0.7 Pyrexia 19 1.8 16 2.2 Mucositis Includes oropharyngeal pain, stomatitis, mucosal inflammation, mouth ulceration, odynophagia, aphthous ulcer, esophageal pain, and related terms.
17 0.4 11 0 Edema Includes edema, peripheral edema, pulmonary edema, generalized edema, and related terms.
11 0.7 17 1.1 Musculoskeletal and connective tissue disorders Musculoskeletal pain Includes back pain, pain in extremity, myalgia, bone pain, neck pain, spinal pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, and sacral pain.
24 0.4 16 0.4 Muscle contracture Includes muscle spasms and muscle contractions involuntary.
18 0 19 0 Respiratory, thoracic and mediastinal disorders Cough 21 0 19 0 Procedural complications Infusion-related reaction Includes infusion-related reaction and cytokine release syndrome.
16 0.7 16 0.4 Nervous system disorders Peripheral neuropathy Includes peripheral neuropathy, paresthesia, peripheral sensory neuropathy, neuralgia, dysesthesia, hyperesthesia, and peripheral motor neuropathy.
12 0 11 0.4 Headache 10 0.4 7 0 Metabolism and nutrition disorders Decreased appetite 10 0 9 0.7 The table includes a combination of grouped and ungrouped terms.
Adverse reactions were graded using NCI CTCAE version 5.0 In the MONJUVI arm, clinically relevant adverse reactions in < 10% of patients with relapsed or refractory FL included thrombosis, febrile neutropenia, second primary malignancy, sepsis, interstitial lung disease, and tumor lysis syndrome.
Table 7 summarizes the laboratory abnormalities in inMIND.
Grade 4 laboratory abnormalities in > 1% of patients included neutrophils decreased (19%), platelets decreased (4%) and lymphocytes decreased (1.8%).
Table 7: Select Laboratory Abnormalities (> 20%) Worsening from Baseline in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide and Rituximab The denominator used to calculate the rate varied from 268 - 274 based on the number of patients with a baseline value and at least 1 post-treatment value.
Placebo in Combination with Lenalidomide and Rituximab All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematology Neutrophils decreased 75 48 71 44 Hemoglobin decreased 60 9 54 7 Lymphocytes decreased 57 22 51 19 Platelets decreased 40 8 43 9 Chemistry Alanine aminotransferase increased 47 1.5 42 1.5 Alkaline phosphatase increased 33 0 27 0 Creatinine increased 29 1.5 30 0.7 Aspartate aminotransferase increased 29 0 31 0.4 Glucose increased 28 0.4 28 1.1 Potassium decreased 24 3.3 24 3 Sodium decreased 24 1.5 22 0.4
( 6.1 ) The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes.
To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Diffuse Large B-cell Lymphoma The safety of MONJUVI in patients with relapsed or refractory DLBCL was evaluated in L-MIND [see Clinical Studies ( 14 .1 )].
Patients (N = 81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle; Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle; Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.
Among patients who received MONJUVI, 57% were exposed for 6 months or longer, 42% were exposed for greater than one year, and 24% were exposed for greater than two years.
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 interruptions 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, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
Table 4 summarizes the adverse reactions in L-MIND.
Table 4: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Adverse Reaction MONJUVI in Combination with Lenalidomide (N = 81) All Grades (%) Grade 3 or 4 (%) Blood and lymphatic system disorders Neutropenia 51 49 Anemia 36 7 Thrombocytopenia 31 17 Febrile neutropenia 12 12 Infections Respiratory tract infection Respiratory tract infection includes lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection, bronchitis, pneumonia, nasopharyngitis, and related terms.
51 12 Urinary tract infection Urinary tract infection includes urinary tract infection, urinary tract infection bacterial, and related terms.
17 4.9 General disorders and administration site conditions Fatigue Fatigue includes asthenia and fatigue.
38 3.7 Pyrexia 24 1.2 Peripheral edema 24 0 Gastrointestinal disorders Diarrhea 36 1.2 Constipation 17 0 Abdominal pain Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper.
15 1.2 Nausea 15 0 Vomiting 15 0 Respiratory, thoracic and mediastinal disorders Cough 26 1.2 Dyspnea 12 1.2 Metabolism and nutrition disorders Decreased appetite 22 0 Hypokalemia 19 6 Musculoskeletal and connective tissue disorders Back pain 19 2.5 Muscle spasms 15 0 Skin and subcutaneous tissue disorders Rash Rash includes rash, rash maculopapular, rash pruritic, rash erythematous, and rash pustular.
15 2.5 Pruritus 10 1.2 Clinically relevant adverse reactions in < 10% of patients with relapsed or refractory DLBCL who received MONJUVI in L-MIND were: Blood and lymphatic system disorders: lymphopenia (6%) General disorders and administration site conditions: infusion-related reaction (6%) Infections: sepsis (4.9%) Investigations: weight decreased (4.9%) Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%) Neoplasms: basal cell carcinoma (1.2%) Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%) Respiratory, thoracic and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%) Skin and subcutaneous tissue disorders: erythema (4.9%), alopecia (2.5%), hyperhidrosis (2.5%) Table 5 summarizes the laboratory abnormalities in L-MIND.
Table 5: Select Laboratory Abnormalities (≥ 20%) Worsening from Baseline in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value.
All Grades (%) Grade 3 or 4 (%) Chemistry Glucose increased 49 5 Calcium decreased 47 1.4 Gamma glutamyl transferase increased 34 5 Albumin decreased 26 0 Magnesium decreased 22 0 Urate increased 20 7 Phosphate decreased 20 5 Creatinine increased 20 1.4 Aspartate aminotransferase increased 20 0 Coagulation Activated partial thromboplastin time increased 46 4.1 Relapsed or Refractory Follicular Lymphoma The safety of MONJUVI in patients with relapsed or refractory FL was evaluated in the inMIND trial [see Clinical Studies (14.2)].
Patients received MONJUVI 12 mg/kg (N = 274) or placebo (N = 272) intravenously for a maximum of 12 cycles in combination with lenalidomide 20 mg (Days 1-21 of Cycles 1 to 12) and rituximab 375 mg/m 2 (Cycles 1 to 5).
MONJUVI was administered as follows: Cycle 1 to 3: Days 1, 8, 15, and 22 of each 28-day cycle; Cycles 4 to 12: Days 1 and 15 of each 28-day cycle.
In the MONJUVI arm, 54% of patients completed all 12 cycles.
The median age in that arm was 64 years (range: 36-88 years); 20% were age 75 years or older; 55% were male; 80% were White, 15% Asian, and 0.4% Black.
In the MONJUVI 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 MONJUVI in 11% of patients and dosage interruptions in 74%.
The most frequent adverse reactions leading to dosage interruptions of MONJUVI were neutropenia (37% of all patients), COVID-19 (22%), pneumonia (11%), and infusion-related reaction (8%).
The most common adverse reactions (≥ 20%) in recipients of MONJUVI, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.
Table 6 summarizes the adverse reactions in inMIND.
Adverse reactions occurring at least 5% more frequently in the MONJUVI arm included COVID-19 infection, pneumonia, diarrhea, pruritus, fatigue, musculoskeletal pain, and mucositis.
Table 6: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Adverse Reaction MONJUVI in Combination with Lenalidomide and Rituximab (N = 274) Placebo in Combination with Lenalidomide and Rituximab (N = 272) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Infections Respiratory tract infection 56 18 56 9 COVID-19 infection Includes COVID-19, COVID-19 pneumonia, and coronavirus test positive.
34 Includes 2 cases in each arm with fatal outcome.
10 24 2.9 Pneumonia Includes pneumonia, COVID-19 pneumonia, pneumonia fungal, Pneumocystis jirovecii pneumonia, and other types of pneumonia.
18 14 11 Includes 3 cases with fatal outcome, including 2 reported under COVID-19 infection.
7 Upper respiratory tract infection Includes upper respiratory tract infection, nasopharyngitis, sinusitis, laryngitis, and related terms.
17 1.1 22 0.4 Gastrointestinal disorders Diarrhea 38 0.7 28 1.8 Constipation 29 0.7 25 0 Nausea 18 0.4 14 0.4 Abdominal pain 13 0 18 2.2 Skin and subcutaneous tissue disorders Rash Includes rash, urticaria, dermatitis, drug eruption, and related terms.
37 3.6 33 1.5 Pruritus 16 0.4 10 0 General disorders Fatigue Includes fatigue and asthenia.
34 2.9 25 0.7 Pyrexia 19 1.8 16 2.2 Mucositis Includes oropharyngeal pain, stomatitis, mucosal inflammation, mouth ulceration, odynophagia, aphthous ulcer, esophageal pain, and related terms.
17 0.4 11 0 Edema Includes edema, peripheral edema, pulmonary edema, generalized edema, and related terms.
11 0.7 17 1.1 Musculoskeletal and connective tissue disorders Musculoskeletal pain Includes back pain, pain in extremity, myalgia, bone pain, neck pain, spinal pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, and sacral pain.
24 0.4 16 0.4 Muscle contracture Includes muscle spasms and muscle contractions involuntary.
18 0 19 0 Respiratory, thoracic and mediastinal disorders Cough 21 0 19 0 Procedural complications Infusion-related reaction Includes infusion-related reaction and cytokine release syndrome.
16 0.7 16 0.4 Nervous system disorders Peripheral neuropathy Includes peripheral neuropathy, paresthesia, peripheral sensory neuropathy, neuralgia, dysesthesia, hyperesthesia, and peripheral motor neuropathy.
12 0 11 0.4 Headache 10 0.4 7 0 Metabolism and nutrition disorders Decreased appetite 10 0 9 0.7 The table includes a combination of grouped and ungrouped terms.
Adverse reactions were graded using NCI CTCAE version 5.0 In the MONJUVI arm, clinically relevant adverse reactions in < 10% of patients with relapsed or refractory FL included thrombosis, febrile neutropenia, second primary malignancy, sepsis, interstitial lung disease, and tumor lysis syndrome.
Table 7 summarizes the laboratory abnormalities in inMIND.
Grade 4 laboratory abnormalities in > 1% of patients included neutrophils decreased (19%), platelets decreased (4%) and lymphocytes decreased (1.8%).
Table 7: Select Laboratory Abnormalities (> 20%) Worsening from Baseline in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide and Rituximab The denominator used to calculate the rate varied from 268 - 274 based on the number of patients with a baseline value and at least 1 post-treatment value.
Placebo in Combination with Lenalidomide and Rituximab All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematology Neutrophils decreased 75 48 71 44 Hemoglobin decreased 60 9 54 7 Lymphocytes decreased 57 22 51 19 Platelets decreased 40 8 43 9 Chemistry Alanine aminotransferase increased 47 1.5 42 1.5 Alkaline phosphatase increased 33 0 27 0 Creatinine increased 29 1.5 30 0.7 Aspartate aminotransferase increased 29 0 31 0.4 Glucose increased 28 0.4 28 1.1 Potassium decreased 24 3.3 24 3 Sodium decreased 24 1.5 22 0.4