ia (11%).
Table 4 Selected Laboratory Abnormalities Worsening from Baseline in Patients withRelapsed or Refractory DLBCL and ≥5% More in the POLIVY Plus
Bendamustine and Rituximab Product Group
Laboratory Parametera
POLIVY + BR BR
n = 45 n = 39
All Grades,
(%)
Grade 3–4,
(%)
All Grades,
(%)
Grade 3–4, (%)
Hematologic
Lymphocyte count decreased 87 87 90 82
Neutrophil count decreased 78 61 56 33
Hemoglobin decreased 78 18 62 10
Platelet count decreased 76 31 64 26
Chemistry
Creatinine increased 87 4.4 77 5
Calcium decreased 44 9 26 0
SGPT/ALT increased 38 0 8 2.6
SGOT/AST increased 36 0 26 2.6
Lipase increased 36 9 13 5
Phosphorus decreased 33 7 28 8
Amylase increased 24 0 18 2.6
Potassium decreased 24 11 28 5
aIncludes laboratory abnormalities that are new or worsening in grade or with worsening from baselineunknown.
Safety was also eva luated in 173 adult patients with relapsed or refractory lymphoma whoreceived POLIVY, bendamustine, and either a rituximab product or obinutuzumab in StudyGO29365, including the 45 patients with DLBCL described above. In the expanded safetypopulation, the median age was 66 years (range 27 – 86), 57% were male, 91% had an ECOGperformance status of 0-1, and 32% had a history of peripheral neuropathy at baseline.
Fatal adverse reactions occurred in 4.6% of recipients of POLIVY within 90 days of lasttreatment, with infection as a leading cause. Serious adverse reactions occurred in 60%, mostoften from infection.
Table 5 summarizes the most common adverse reactions in the expanded safety population. Theoverall safety profile was similar to that described above. Adverse reactions in ≥20% of patientswere diarrhea, neutropenia, peripheral neuropathy, fatigue, thrombocytopenia, pyrexia, decreasedappetite, anemia, and vomiting. Infection-related adverse reactions in >10% of patients includedupper respiratory tract infection, febrile neutropenia, pneumonia, and herpesvirus infection.
Table 5 Most Common Adverse Reactions (≥20% Any Grade or ≥5% Grade 3 orHigher) in Recipients of POLIVY and Chemoimmunotherapy for Relapsed or
Refractory Lymphoma
Adverse Reaction by Body System
POLIVY + Bendamustine + Rituximab
Product or Obinutuzumab
n = 173
All Grades,
%
Grade 3 or Higher,
%
Blood and Lymphatic System Disorders
Neutropenia 44 39
Thrombocytopenia 31 23
Anemia 28 14
Febrile neutropeniaa 13 13
Leukopenia 13 8
Lymphopenia 12 12
Nervous System Disorders
Peripheral neuropathy 40 2.3
Gastrointestinal Disorders
Diarrhea 45 8
Vomiting 27 2.9
General Disorders
Fatigue 40 5
Pyrexia 30 2.9
Decreased appetite 29 1.7
Infections
Pneumonia 13 10b
Sepsis 6 6
c
Metabolism and Nutrition Disorders
Hypokalemia 18 6
The table includes a combination of grouped and ungrouped terms.
a Primary prophylaxis with granulocyte colony stimulating factor was given to 46% of all patients.
b
Includes 5 events with fatal outcome.
c
Includes 4 events with fatal outcome.
Other clinically relevant adverse reactions (<20% any grade) included:
General disorders: infusion-related reaction (7%)
Infection: upper respiratory tract infection (16%), lower respiratory tract infection (10%),
herpesvirus infection (12%), cytomegalovirus infection (1.2%)
Respiratory: dyspnea (19%), pneumonitis (1.7%)
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