SAFETY PROFILE1

  1. 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
  2. Serious adverse reactions occurred in 52% of patients who received MONJUVI (tafasitamab-cxix)
    1. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%)
  3. 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%)
  4. 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%
    1. 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%)
  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%
    1. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%)
  6. 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

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
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.

  1. Clinically relevant adverse reactions in <10% of patients in L-MIND were:
    1. Blood and lymphatic system disorders: lymphopenia (6%)
    2. General disorders and administration site conditions: IRR (6%)
    3. Infections: sepsis (4.9%)
    4. Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%)
    5. Neoplasms benign, malignant, and unspecified: basal cell carcinoma (1.2%)
    6. Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%)
    7. Respiratory, thoracic, and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%)
    8. 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.

SAFETY BY TREATMENT PHASE

Combination Therapy Monotherapy

MONJUVI + LENALIDOMIDE DURING CYCLES 1 TO 12 BEFORE DISCONTINUATION OF LENALIDOMIDE2

Adverse reactions recorded during 1-year primary analysis (N=80)#**††

L-MIND safety by combination therapy phase. MONJUVI + lenalidomide during cycles 1 to 12 before discontinuation of lenalidomide.

#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)#**

L-MIND safety by monotherapy therapy phase. MONJUVI monotherapy—cycle 13 onward or after discontinuation of lenalidomide.
  1. During the 1-year primary analysis, 34 patients continued to the MONJUVI monotherapy phase following 12 cycles of combination therapy2
    1. 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
  1. During the 1-year primary analysis, 34 patients continued to the MONJUVI monotherapy phase following 12 cycles of combination therapy2
    1. 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