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 (tafasitamab-cxix)
- Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%)
- Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%), and sudden death (1.2%)
-
Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%
- The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%)
-
Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%
- The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%)
- The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%)
ADVERSE REACTIONS1
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 |
Abdominal pain† | 15 | 1.2 |
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 |
Skin and subcutaneous tissue disorders | ||
Rash∥ | 15 | 2.5 |
Pruritus | 10 | 1.2 |
*Fatigue includes asthenia and fatigue.
†Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper.
‡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.
∥Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous, rash pustular.
-
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%)
- 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
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.
SAFETY BY TREATMENT PHASE
MONJUVI + LENALIDOMIDE DURING CYCLES 1 TO 12 BEFORE DISCONTINUATION OF LENALIDOMIDE2
Adverse reactions recorded during 1-year primary analysis (N=80)#**††

#The cutoff date for the primary analysis was November 30, 2018 and occurred after the last patient enrolled had completed 12 months of follow-up.3
**Adverse reaction collection period included 30 days after end of treatment.2
††81 patients were enrolled; 80 patients received MONJUVI plus lenalidomide and 1 received MONJUVI alone.2
MONJUVI MONOTHERAPY—CYCLE 13 ONWARD OR AFTER DISCONTINUATION OF LENALIDOMIDE2
Adverse reactions recorded during 1-year primary analysis (N=51)#**

-
During the 1-year primary analysis, 34 patients continued to the MONJUVI monotherapy phase following 12 cycles of combination therapy2
- 1 (3%) of the 34 patients discontinued MONJUVI monotherapy due to an adverse reaction
#The cutoff date for the primary analysis was November 30, 2018 and occurred after the last patient enrolled had completed 12 months of follow-up.3
**Adverse reaction collection period included 30 days after end of treatment.2
MONJUVI + LENALIDOMIDE DURING CYCLES 1 TO 12 BEFORE DISCONTINUATION OF LENALIDOMIDE2
Adverse reactions recorded during
1-year primary analysis (N=80)#**††
Adverse Reactions | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Neutropenia | 1 | 0 | 30 | 16 |
Anemia | 11 | 15 | 8 | 0 |
Thrombocytopenia | 11 | 3 | 11 | 4 |
Diarrhea | 18 | 10 | 1 | 0 |
Pyrexia | 18 | 3 | 1 | 0 |
Peripheral edema | 11 | 10 | 0 | 0 |
Asthenia | 14 | 6 | 1 | 0 |
Cough | 14 | 5 | 1 | 0 |
Hypokalemia | 9 | 4 | 4 | 1 |
Decreased appetite | 13 | 5 | 0 | 0 |
Fatigue | 8 | 5 | 3 | 0 |
Nausea | 10 | 5 | 0 | 0 |
Leukopenia | 0 | 8 | 6 | 1 |
Constipation | 11 | 4 | 0 | 0 |
Muscle spasms | 10 | 4 | 0 | 0 |
Dyspnea | 8 | 4 | 1 | 0 |
Back pain | 5 | 5 | 3 | 0 |
Bronchitis | 3 | 8 | 0 | 1 |
Vomiting | 6 | 5 | 0 | 0 |
Febrile neutropenia | 0 | 0 | 10 | 1 |
#The cutoff date for the primary analysis was November 30, 2018 and occurred after the last patient enrolled had completed 12 months of follow-up.3
**Adverse reaction collection period included 30 days after end of treatment.2
††81 patients were enrolled; 80 patients received MONJUVI plus lenalidomide and 1 received MONJUVI alone.2
MONJUVI MONOTHERAPY—CYCLE 13 ONWARD OR AFTER DISCONTINUATION OF LENALIDOMIDE2
Adverse reactions recorded during
1-year primary analysis (N=51)#**
Adverse Reactions | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Neutropenia | 2 | 4 | 2 | 4 |
Anemia | 8 | 0 | 0 | 0 |
Thrombocytopenia | 2 | 0 | 0 | 0 |
Diarrhea | 8 | 6 | 0 | 0 |
Pyrexia | 4 | 4 | 0 | 0 |
Peripheral edema | 2 | 0 | 0 | 0 |
Asthenia | 4 | 2 | 2 | 0 |
Cough | 4 | 4 | 0 | 0 |
Hypokalemia | 0 | 0 | 2 | 0 |
Decreased appetite | 6 | 0 | 0 | 0 |
Fatigue | 4 | 0 | 0 | 0 |
Nausea | 2 | 0 | 0 | 0 |
Leukopenia | 2 | 2 | 2 | 0 |
Constipation | 0 | 0 | 0 | 0 |
Muscle spasms | 2 | 0 | 0 | 0 |
Dyspnea | 0 | 0 | 0 | 0 |
Back pain | 8 | 0 | 0 | 0 |
Bronchitis | 2 | 4 | 0 | 0 |
Vomiting | 4 | 0 | 0 | 0 |
Febrile neutropenia | 0 | 0 | 0 | 0 |
- During the 1-year primary analysis, 34 patients continued to the MONJUVI monotherapy phase following 12 cycles of combination therapy2
- 1 (3%) of the 34 patients discontinued MONJUVI monotherapy due to an adverse reaction
#The cutoff date for the primary analysis was November 30, 2018 and occurred after the last patient enrolled had completed 12 months of follow-up.3
**Adverse reaction collection period included 30 days after end of treatment.2