Safety Profile1

  • 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

  • Serious adverse reactions occurred in 52% of patients who received MONJUVI

    • Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%)

  • Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%), and sudden death (1.2%)

  • Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%

    • The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%)

  • Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%

    • The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%)

ADVERSE REACTIONS1

Adverse reactions (≥10%) in patients with R/R DLBCL who received MONJUVI in L-MIND
  MONJUVI (N=81)
Adverse Reaction All Grades
(%)		 Grade 3 or 4
(%)
Blood and lymphatic system disorders    
Neutropenia 51 49
Anemia 36 7
Thrombocytopenia 31 17
Febrile neutropenia 12 12
General disorders and administration site conditions    
Fatigue* 38 3.7
Pyrexia 24 1.2
Peripheral edema 24 0
Gastrointestinal disorders    
Diarrhea 36 1.2
Constipation 17 0
Nausea 15 0
Vomiting 15 0
Respiratory, thoracic, and mediastinal disorders    
Cough 26 1.2
Dyspnea 12 1.2
Infections    
Respiratory tract infection† 24 4.9
Urinary tract infection‡ 17 4.9
Bronchitis 16 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

*Fatigue includes asthenia and fatigue.

†Respiratory tract infection includes: lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection.

‡Urinary tract infection includes: urinary tract infection, Escherichia urinary tract infection, urinary tract infection bacterial, urinary tract infection enterococcal.

  • Clinically relevant adverse reactions in <10% of patients in L-MIND were:

    • Blood and lymphatic system disorders: lymphopenia (6%)

    • General disorders and administration site conditions: IRR (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 benign, malignant, and unspecified: 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%)

IRR=infusion-related reaction.

LABORATORY ABNORMALITIES1

Select laboratory abnormalities (>20%) worsening from baseline in patients with R/R DLBCL who received MONJUVI in L-MIND
  MONJUVI§
Laboratory Abnormality 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

§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.

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assays. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described in the Prescribing Information with the incidence of antibodies in other studies or to other tafasitamab products may be misleading.

Overall, no treatment-emergent or treatment-boosted anti-tafasitamab antibodies were observed. No clinically meaningful differences in the pharmacokinetics, efficacy, or safety profile of tafasitamab-cxix were observed in 2.5% of 81 patients with relapsed or refractory DLBCL with pre-existing anti-tafasitamab antibodies in L-MIND.