ZYNLONTA® safety profile2
Pooled safety analysis: Phase 1 and LOTIS-2 studies of patients who received ZYNLONTA® at an initial dose of 0.15 mg/kg (N=215)
The most common (>20%) adverse reactions, including laboratory abnormalities, were thrombocytopenia, increased GGT, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.
LOTIS-2 study (N=145)
Serious adverse reactions occurred in 28% of patients. The most common serious adverse reactions that occurred in ≥2% of patients were febrile neutropenia, pneumonia, edema, pleural effusion, and sepsis. Fatal adverse reactions occurred in 1% of patients, due to infection.
Permanent discontinuation due to an adverse reaction occurred in 19% of patients
Adverse reactions resulting in permanent discontinuation in ≥2% were GGT increased, edema, and effusion.
Dose reductions due to an adverse reaction of ZYNLONTA® occurred in 8% of patients
Adverse reaction resulting in dose reduction of ZYNLONTA® in ≥4% was GGT increased.
Dosage interruptions due to an adverse reaction occurred in 49% of patients
Adverse reactions leading to dose interruption in ≥5% were GGT increased, neutropenia, thrombocytopenia, and edema.
In LOTIS-2, 55% of patients were ≥65 years of age. No overall differences in safety or effectiveness were observed between older (>65 years) and younger patients.
GGT = gamma-glutamyltransferase.
Adverse reactions (≥10%) in 145 patients who received ZYNLONTA® in LOTIS-22
|Adverse Reaction||All Grades
|Grade 3 or 4
|General Disorders and Administration Site Conditions|
|Skin and Subcutaneous Tissue Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Metabolism and Nutrition Disorders|
|Upper respiratory tract infectionh||10||<1b|
aFatigue includes fatigue, asthenia, and lethargy.
bNo Grade 4 adverse reactions occurred.
cEdema includes edema, face edema, generalized edema, peripheral edema, ascites, fluid overload, peripheral swelling, swelling, and swelling face.
dRash includes rash, rash erythematous, rash maculopapular, rash pruritic, rash pustular, erythema, generalized erythema, dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis exfoliative generalized, and palmar-plantar erythrodysesthesia syndrome.
eAbdominal pain includes abdominal pain, abdominal discomfort, abdominal pain lower, and abdominal pain upper.
fMusculoskeletal pain includes musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, back pain, limb discomfort, myalgia, neck pain, non-cardiac chest pain, and pain in extremity.
gDyspnea includes dyspnea, and dyspnea exertional.
hUpper respiratory tract infection includes upper respiratory tract infection, upper respiratory tract congestion, nasopharyngitis, rhinitis, rhinovirus infection, and sinusitis.
Clinically relevant adverse reactions in <10% of patients (all grades) who received ZYNLONTA® included:
- Blood and lymphatic system disorders: Febrile neutropenia (3%)
- Cardiac disorders: Pericardial effusion (3%)
- Infections: Pneumoniaa (5%), sepsisb (2%)
- Skin and subcutaneous disorders: Hyperpigmentation (4%)
- General disorders: Infusion site extravasation (<1%)
aPneumonia includes pneumonia and lung infection.
bSepsis includes sepsis, escherichia sepsis, and septic shock.