MAINTENANCE THERAPY OF RECURRENT OVARIAN CANCER WITH ZEJULA (niraparib)

Safety Data From the NOVA Trial


Hematologic ars

Most hematologic ARs occurred during the first 3 months of therapy1

NOVA: Hematologic ARs reported in ≥10% of patients receiving ZEJULA2

Chart showing the incidence of hematologic adverse reactions in greater than or equal to 10% of patients receiving ZEJULA (niraparib)
Chart showing the incidence of hematologic adverse reactions in greater than or equal to 10% of patients receiving ZEJULA (niraparib)

The rate of grade ≥3 thrombocytopenia after cycle 3 was 2% in patients receiving ZEJULA.3

Abnormal laboratory findings (grades 1-4) in ≥25% of patients receiving ZEJULA.2

  • Decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%), and increase in ALT (28%)

Common Terminology Criteria for Adverse Events version 4.02.

Includes preferred terms of neutropenic infection, neutropenic sepsis, and febrile neutropenia.

Discontinuation due to hematologic adverse reactions was uncommon2

3% Rate of discontinuation


Thrombocytopenia

2% Rate of discontinuation


Neutropenia

1% Rate of discontinuation


Anemia

  • Hematologic ARs generally occurred within the first 3 treatment cycles; after dose adjustment on the basis of an individual adverse event profile, the incidence of grade 3/4 thrombocytopenia, neutropenia, or fatigue was infrequent beyond cycle 33
  • 1 patient (<1%) in the ZEJULA arm experienced febrile neutropenia4
  • In the same clinical trial, 15% of the overall population discontinued treatment due to ARs2

Thrombocytopenia was typically transient with dose modification3,4

Platelet levels decreased initially but showed stabilization after cycle 3 with appropriate dose modification3

  • The median time to onset of grade 3/4 thrombocytopenia was 23 days in the ZEJULA treatment arm4
  • Most grade 3/4 thrombocytopenia events were transient with dose interruption or dose reduction. The median duration was 10 days4

Change in platelet levels from baseline over time3

Graph showing change in platelet levels from baseline over time in the NOVA trial
Graph showing change in platelet levels from baseline over time

No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia.5

  • All bleeding events associated with thrombocytopenia were grade 1/2; 1 patient had grade 3 petechiae and hematoma concurrent with a serious adverse event of pancytopenia5

Incidence of grade 3/4 thrombocytopenia in
the NOVA trial; treatment months 1-54

Graph showing incidence of grade 3/4 thrombocytopenia in the ZEJULA (niraparib) arm of the NOVA trial
raph showing incidence of grade 3/4 thrombocytopenia in the ZEJULA (niraparib) arm of the NOVA trial

Non-Hematologic ars

The side effect profile of ZEJULA is well-characterized2

Adverse reactions reported in ≥10% of patients receiving ZEJULA2

Chart showing the side effect profile of ZEJULA (niraparib), as reported in greater than or equal to 10% of patients in the NOVA trial
Chart showing the side effect profile of ZEJULA (niraparib), as reported in greater than or equal to 10% of patients in the NOVA trial

Side effects were manageable with dose interruption and modification.

  • ARs led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%)2
  • No increase in all-grade diarrhea was observed with ZEJULA vs placebo5
  • No on-treatment deaths were reported during the study5

Monitoring

Monitoring complete blood counts, blood pressure, and heart rate helps identify the need to dose modify2

Blood counts

1st month

1x a
week


Rest of year

1x a
month


After year 1§

1x every
2-3 months

Blood pressure and heart rate

1st and 2nd month

1x a
week


Rest of year

1x a
month


After year 1§

1x every
2-3 months

Monitor periodically. Schedule provided as an example.