Zejula Drug Information

Generic name: NIRAPARIB

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Uses of Zejula

First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.

Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Dosage & Administration of Zejula

Patient Selection First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer Select patients for first-line maintenance treatment of advanced ovarian cancer with ZEJULA based on the presence of HRD defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Information on FDA‑authorized tests for the detection of HRD‑positive status for this indication is available at https://www.fda.gov/companiondiagnostics. Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer Select patients for the maintenance treatment of recurrent ovarian cancer with ZEJULA based on the presence of deleterious or suspected deleterious germline BRCA mutations.

Information on FDA‑authorized tests for the detection of deleterious or suspected deleterious germline BRCA mutations for this indication is available at https://www.fda.gov/companiondiagnostics.

Recommended Dosage and Administration

Continue treatment with ZEJULA until disease progression or unacceptable toxicity. Instruct patients to take their dose of ZEJULA at approximately the same time each day. Advise patients to swallow tablets whole and not to chew, crush, or split ZEJULA prior to swallowing.

ZEJULA may be taken with or without food. Bedtime administration may be a potential method for managing nausea. In the case of a missed dose of ZEJULA, instruct patients to take their next dose at its regularly scheduled time.

If a patient vomits or misses a dose of ZEJULA, an additional dose should not be taken. First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer • For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg taken orally once daily. • For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg taken orally once daily. For the maintenance treatment of advanced ovarian cancer, start ZEJULA no later than 12 weeks after their most recent platinum-containing regimen.

Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer The recommended dosage of ZEJULA is 300 mg taken orally once daily.

Dosage Modifications for Adverse Reactions

To manage adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. The recommended dosage modifications for adverse reactions are listed in Tables 1, 2, and 3. Table 1.

Recommended Dosage Modifications for Adverse Reactions Table 2. Dosage Modifications for Non-Hematologic Adverse Reactions CTCAE = Common Terminology Criteria for Adverse Events. Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management • Withhold ZEJULA for a maximum of 28 days or until resolution of adverse reaction. • Resume ZEJULA at a reduced dose per Table 1.

CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day Discontinue ZEJULA. Table 3. Dosage Modifications for Hematologic Adverse Reactions a If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue ZEJULA.

Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Dosage Modifications for Hepatic Impairment

For patients with moderate hepatic impairment (total bilirubin ≥1.5 to 3 x ULN and any AST level), the recommended dosage of ZEJULA is 200 mg once daily, regardless of body weight or platelet count. Monitor patients for hematologic toxicity and reduce the dose, if needed.

Table 1. Recommended Dosage Modifications for Adverse Reactions
a If further dose reduction below 100 mg/day is required, discontinue ZEJULA.
Starting Dose Level	200 mg	300 mg
First dose reduction	100 mg/day a	200 mg/day
Second dose reduction	Discontinue ZEJULA.	100 mg/day a

Table 2. Dosage Modifications for Non-Hematologic Adverse Reactions
CTCAE = Common Terminology Criteria for Adverse Events.
Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management	• Withhold ZEJULA for a maximum of 28 days or until resolution of adverse reaction. • Resume ZEJULA at a reduced dose per Table 1.
CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day	Discontinue ZEJULA.

Table 3. Dosage Modifications for Hematologic Adverse Reactions
a If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue ZEJULA [see Warnings and Precautions ( 5.1, 5.2 )].
Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time [see Warnings and Precautions ( 5.2 )].
Platelet count <100,000/mcL	First occurrence: • Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL. • Resume ZEJULA at same or reduced dose per Table 1. • If platelet count is <75,000/mcL, resume at a reduced dose. Second occurrence: • Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL. • Resume ZEJULA at a reduced dose per Table 1. • Discontinue ZEJULA if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily. a
Neutrophil <1,000/mcL or hemoglobin <8 g/dL	• Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1,500/mcL or hemoglobin returns to ≥9 g/dL. • Resume ZEJULA at a reduced dose per Table 1. • Discontinue ZEJULA if neutrophils and/or hemoglobin have not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily. a
Hematologic adverse reaction requiring transfusion	• For patients with platelet count ≤10,000/mcL, platelet transfusion should be considered. If there are other risk factors such as coadministration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count. • Resume ZEJULA at a reduced dose per Table 1.

Side Effects of Zejula

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a pooled safety population of patients (n = 1,314) with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with ZEJULA monotherapy including PRIMA (n = %). First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer The safety of ZEJULA for the treatment of patients with advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was studied in the PRIMA trial, a placebo-controlled, double-blind study in which 484 patients received ZEJULA.

HRD-Positive Patients Receiving ZEJULA in PRIMA: Serious adverse reactions occurred in 30% of patients receiving ZEJULA. Serious adverse reactions in >2% of patients were thrombocytopenia (11%) and anemia (5%). Permanent discontinuation due to adverse reactions occurred in 11% of patients who received ZEJULA.

Tables 4 and 5 summarize the common adverse reactions and abnormal laboratory findings observed in the PRIMA trial. Table 4. Adverse Reactions Reported in ≥10% of HRD-Positive Patients Receiving ZEJULA in PRIMA a % of HRD-Positive Patients Receiving ZEJULA in PRIMA 1 0 HRD-Positive Patients Receiving ZEJULA with Dose Based on Baseline Weight or Platelet Count in PRIMA: Among patients who received ZEJULA with the dose based on weight and platelet count (n = 86), the median duration of treatment was 12 months (range: 4 days to 16 months).

Adverse reactions resulting in permanent discontinuation in >2% of patients who received ZEJULA included nausea (3.5%). Tables 6 and 7 summarize adverse reactions and abnormal laboratory findings observed in this group. Table 6.

Adverse Reactions Reported in ≥10% of HRD-Positive Patients Receiving ZEJULA Based on Baseline Weight or Platelet Count in PRIMA a % of HRD-Positive Patients Receiving ZEJULA Based on Baseline Weight or Platelet Count in PRIMA 0 0 Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer The safety of monotherapy with ZEJULA 300 mg once daily has been studied in 136 patients with platinum-sensitive recurrent g BRCA mut ovarian, fallopian tube, and primary peritoneal cancer in the NOVA trial. The permanent discontinuation rate due to adverse reactions in NOVA was 13%. The median exposure to ZEJULA in these patients was 367 days.

Table 8 and Table 9 summarize the common adverse reactions and abnormal laboratory findings, respectively, observed in patients treated with ZEJULA in the g BRCA mut cohort in NOVA. Table 8. Table 9.

Abnormal Laboratory Findings in ≥25% of Patients Receiving ZEJULA in NOVA gBRCAmut Cohort 2

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ZEJULA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders Pancytopenia.

Immune System Disorders Hypersensitivity (including anaphylaxis). Nervous System Disorders Posterior reversible encephalopathy syndrome (PRES). Psychiatric Disorders Confusional state/disorientation, hallucination, cognitive impairment (e.g., memory impairment, concentration impairment).

Respiratory, Thoracic, and Mediastinal Disorders Non-infectious pneumonitis. Skin and Subcutaneous Tissue Disorders Photosensitivity. Vascular Disorders Hypertensive crisis.

Table 4. Adverse Reactions Reported in ≥10% of HRD-Positive Patients Receiving ZEJULA in PRIMA a
AST/ALT = Aspartate aminotransferase/alanine aminotransferase.
a All adverse reactions in the table consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
b Common Terminology Criteria for Adverse Events version 4.02.
c Includes neutropenia, neutropenic infection, neutropenic sepsis, and febrile neutropenia.
d Includes leukopenia, lymphocyte count decreased, lymphopenia, and white blood cell count decreased.
e Includes blood creatinine increased, blood urea increased, acute kidney injury, and renal failure.
Adverse Reaction	Grades 1-4 b		Grades 3-4 b
Adverse Reaction	ZEJULA (n = 245) %	Placebo (n = 125) %	ZEJULA (n = 245) %	Placebo (n = 125) %
Blood and lymphatic system disorders
Thrombocytopenia	66	4	38	0
Anemia	65	16	31	2
Neutropenia c	43	9	17	2
Leukopenia d	29	10	6	0.8
Gastrointestinal disorders
Nausea	62	34	1	0
Constipation	40	26	1	0.8
Vomiting	23	14	2	0.8
General disorders and administration site conditions
Fatigue	52	44	2	2
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	46	38	0.8	0
Nervous system disorders
Headache	27	15	0.8	0
Dizziness	20	11	0	0
Psychiatric disorders
Insomnia	25	16	0.4	0.8
Anxiety	12	6	0	0
Respiratory, thoracic, and mediastinal disorders
Dyspnea	21	15	0	0.8
Cough	20	14	0	0.8
Metabolism and nutrition disorders
Decreased appetite	20	6	0.4	0
Vascular disorders
Hypertension	20	8	7	2
Investigations
AST/ALT elevation	14	8	3	0
Renal and urinary disorders
Acute kidney injury e	13	3	0	0

Table 5. Abnormal Laboratory Findings in ≥25% of HRD-Positive Patients Receiving ZEJULA in PRIMA
Abnormal Laboratory Finding	Grades 1-4		Grades 3-4
Abnormal Laboratory Finding	ZEJULA (n = 245) %	Placebo (n = 125) %	ZEJULA (n = 245) %	Placebo (n = 125) %
Decreased hemoglobin	85	65	28	2
Decreased leukocytes	72	37	9	0
Decreased platelets	71	11	36	0
Decreased neutrophils	64	28	21	2
Increased glucose	62	57	3	4
Decreased lymphocytes	55	26	9	5
Increased alkaline phosphatase	48	19	2	0.8
Increased creatinine	40	24	0	0
Decreased magnesium	39	35	0.4	0
Increased aspartate aminotransferase	35	18	2	0.8
Increased alanine aminotransferase	32	19	2	2
Increased calcium	31	23	1	0

Table 6. Adverse Reactions Reported in ≥10% of HRD-Positive Patients Receiving ZEJULA Based on Baseline Weight or Platelet Count in PRIMA a
a All adverse reactions in the table consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
b Common Terminology Criteria for Adverse Events version 4.02.
c Includes neutropenia, neutropenic infection, neutropenic sepsis, and febrile neutropenia.
d Includes leukopenia, lymphocyte count decreased, lymphopenia, and white blood cell count decreased.
e Includes blood creatinine increased, blood urea increased, acute kidney injury, and renal failure.
Adverse Reaction	Grades 1-4 b		Grades 3-4 b
Adverse Reaction	ZEJULA (n = 86) %	Placebo (n = 42) %	ZEJULA (n = 86) %	Placebo (n = 42) %
Blood and lymphatic system disorders
Thrombocytopenia	51	2	16	0
Anemia	49	21	22	0
Neutropenia c	35	7	13	0
Leukopenia d	26	7	6	0
Gastrointestinal disorders
Nausea	55	21	0	0
Constipation	26	29	1	2
Vomiting	16	17	0	2.4
General disorders and administration site conditions
Fatigue	47	41	0	0
Nervous system disorders
Headache	24	19	1	0
Dizziness	15	7	0	0
Psychiatric disorders
Insomnia	21	19	0	0
Metabolism and nutrition disorders
Decreased appetite	19	7	1	0
Respiratory, thoracic, and mediastinal disorders
Dyspnea	20	12	0	2
Vascular disorders
Hypertension	16	12	4	5
Renal and urinary disorders
Acute kidney injury e	14	2	0	0

Table 7. Abnormal Laboratory Findings in ≥25% of HRD-Positive Patients Receiving ZEJULA Based on Baseline Weight or Platelet Count in PRIMA
Abnormal Laboratory Finding	Grades 1-4		Grades 3-4
Abnormal Laboratory Finding	ZEJULA (n = 86) %	Placebo (n = 42) %	ZEJULA (n = 86) %	Placebo (n = 42) %
Decreased hemoglobin	74	67	21	0
Decreased leukocytes	70	36	6	0
Decreased platelets	58	17	14	0
Increased glucose	57	62	4	2
Decreased neutrophils	57	31	13	0
Decreased lymphocytes	55	24	6	5
Decreased magnesium	51	41	0	0
Increased alkaline phosphatase	42	12	2	0
Increased creatinine	42	24	0	0
Increased aspartate aminotransferase	31	21	2	0
Increased alanine aminotransferase	30	17	2	2
Increased calcium	29	36	0	0

Table 8. Adverse Reactions Reported in ≥10% of Patients Receiving ZEJULA in NOVA gBRCAmut Cohort
g BRCA mut = Germline BRCA -mutated.
a Common Terminology Criteria for Adverse Events version 4.02.
b Includes platelet count decreased.
c Includes hemoglobin decreased.
d Includes neutrophil count decreased.
e Includes asthenia, malaise, and lethargy.
Adverse Reaction	Grades 1-4 a		Grades 3-4 a
Adverse Reaction	ZEJULA (n = 136) %	Placebo (n = 65) %	ZEJULA (n = 136) %	Placebo (n = 65) %
Gastrointestinal disorders
Nausea	77	34	5	3
Vomiting	40	15	4	0
Constipation	38	18	0.7	2
Dyspepsia	17	12	0	0
Dry mouth	13	3	0.7	0
Blood and lymphatic system disorders
Thrombocytopenia b	71	5	38	2
Anemia c	52	8	33	0
Neutropenia d	31	9	21	3
General disorders and administration site conditions
Fatigue e	61	35	8	2
Nervous system disorders
Headache	35	8	0.7	0
Dizziness	18	9	0	0
Dysgeusia	13	2	0	0
Metabolism and nutrition disorders
Decreased appetite	22	14	0	0
Vascular disorders
Hypertension	21	8	8	5
Psychiatric disorders
Insomnia	18	6	0.7	0
Anxiety	10	11	0.7	0
Respiratory, thoracic, and mediastinal disorders
Dyspnea	17	5	2	0
Cough	16	2	0	0
Nasopharyngitis	13	5	0	0
Musculoskeletal and connective tissue disorders
Back pain	16	11	0.7	0
Infections and infestations
Urinary tract infection	11	9	0	2
Skin and subcutaneous tissue disorders
Rash	10	2	0	0

Table 9. Abnormal Laboratory Findings in ≥25% of Patients Receiving ZEJULA in NOVA gBRCAmut Cohort
g BRCA mut = Germline BRCA- mutated.
Abnormal Laboratory Finding	Grades 1-4		Grades 3-4
Abnormal Laboratory Finding	ZEJULA (n = 136) %	Placebo (n = 65) %	ZEJULA (n = 136) %	Placebo (n = 65) %
Decrease in hemoglobin	85	62	32	0
Decrease in platelet count	81	25	38	2
Decrease in white blood cell count	71	37	9	2
Decrease in absolute neutrophil count	56	34	23	3
Increase in aspartate aminotransferase	35	25	0.7	0
Increase in alanine aminotransferase	25	15	0.7	2

Warnings & Cautions for Zejula

Myelodysplastic Syndrome/Acute Myeloid Leukemia

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with a fatal outcome, have been reported in patients who received ZEJULA. The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer-therapy–related AML varied from 5.5 months to 5 years. All patients who developed secondary MDS/cancer-therapy–related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue ZEJULA if MDS/AML is confirmed.

Bone Marrow Suppression

Hematologic adverse reactions, including thrombocytopenia, anemia, neutropenia, and/or pancytopenia have been reported in patients treated with ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred in 4%, 2%, and 2%, respectively, of patients. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count, ≥Grade 3 thrombocytopenia, anemia, and neutropenia were reported in 22%, 23%, and 15%, respectively, of patients receiving ZEJULA.

Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.

Hypertension and Cardiovascular Effects Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. There were no discontinuations due to hypertension. Discontinuation due to hypertension occurred in <1% of patients.

Monitor blood pressure and heart rate at least weekly for the first 2 months, then monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Medically manage hypertension with antihypertensive medications and adjustment of the dose of ZEJULA, if necessary.

Posterior Reversible Encephalopathy Syndrome

Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Signs and symptoms of PRES include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging.

Monitor all patients treated with ZEJULA for signs and symptoms of PRES. If PRES is suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA in patients previously experiencing PRES is not known.

Embryo-Fetal Toxicity Based on its mechanism of action, ZEJULA can cause fetal harm when administered to a pregnant woman. ZEJULA has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow). Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib.

Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of ZEJULA.

Pregnancy Safety for Zejula

Pregnancy Risk Summary Based on its mechanism of action, ZEJULA can cause fetal harm when administered to pregnant women. There are no data regarding the use of ZEJULA in pregnant women to inform the drug-associated risk. ZEJULA has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).

Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. Apprise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.

Pediatric Use of Zejula

Pediatric Use The safety and effectiveness of ZEJULA have not been established in pediatric patients.

Clinical Studies of Zejula

First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer PRIMA (NCT02655016) was a double-blind, placebo-controlled trial in which patients (N = 733) in complete or partial response to first-line platinum-based chemotherapy were randomized 2:1 to ZEJULA or matched placebo. Initially, the patients received a starting dosage of 300 mg once daily regardless of body weight or platelet count. Patients were randomized post‑completion of first‑line platinum‑based chemotherapy plus surgery.

Randomization was stratified by best response during the front‑line platinum regimen (complete response vs. partial response), neoadjuvant chemotherapy (NACT) (yes vs. no), and HRD status (positive vs. negative or not determined). HRD status was determined using Myriad MyChoice CDx assay. HRD‑positive status included either tumor BRCA mutant (t BRCA m) or a genomic instability score (GIS) ≥42.

The major efficacy outcome measure, progression-free survival (PFS), was determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In some cases, criteria other than RECIST, such as clinical signs and symptoms and increasing CA-125, were also applied. Overall survival (OS) was an additional efficacy outcome measure.

Efficacy was evaluated in 373 patients in the HRD-positive population. The median age was 58 years (range 32 to 83 years). Six percent of patients were Hispanic or Latino.

Seventy-five percent of patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 at trial baseline. Approximately 47% of patients were enrolled in the U.S. or Canada. Sixty-four percent of patients had Stage III disease and 36% had Stage IV disease.

Sixty-three percent of the patients received NACT. Seventy-five percent of the patients had a complete response to the first-line platinum-based chemotherapy. PRIMA demonstrated a statistically significant improvement in PFS for patients randomized to ZEJULA as compared with placebo in the HRD-positive population ( Table 10 and Figure 1 ).

Table 10. Efficacy Results – PRIMA HRD-Positive Population Progression-Free Survival (PFS) a In an exploratory subgroup analysis of patients in the HRD-positive population who were administered a starting dose of ZEJULA or matched placebo based on baseline weight or platelet count (n = 130), the hazard ratio (HR) for PFS was Figure 1. PRIMA Progression-Free Survival – HRD-Positive Population HRD = Homologous Recombination Deficient.

Figure 1

Maintenance Treatment of Recurrent Germline BRCA -Mutated Ovarian Cancer NOVA (NCT01847274) was a double-blind, placebo-controlled trial in which patients (N = 553) with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomized 2:1 to ZEJULA 300 mg orally daily or matched placebo within 8 weeks of the last therapy. Treatment was continued until disease progression or unacceptable toxicity. All patients had received at least 2 prior platinum-containing regimens and were in response (complete or partial) to their most recent platinum-based regimen.

Randomization was stratified by time to progression after the penultimate platinum therapy (6 to <12 months and ≥12 months), use of bevacizumab in conjunction with the penultimate or last platinum regimen (yes/no), and best response during the most recent platinum regimen (complete response and partial response). Eligible patients were assigned to 1 of 2 cohorts based on the results of germline BRCA testing with Myriad BRACAnalysis CDx. Patients with deleterious or suspected deleterious germline BRCA mutations (g BRCA mut) were assigned to the germline BRCA -mutated (g BRCA mut) cohort (n = 203), and those without germline BRCA mutations were assigned to the non-g BRCA mut cohort (n = 350).

The efficacy results are based on the g BRCA mut cohort only. The major efficacy outcome measure, PFS, was determined primarily by central independent assessment per RECIST version 1.1. For the g BRCA mut cohort, the median age of patients was 57 years among patients treated with ZEJULA and 58 years among patients treated with placebo.

Eighty-eight percent of all patients were White. Sixty-six percent of patients receiving ZEJULA and 74% of patients receiving placebo had an ECOG PS of 0 at study baseline. Twenty-four percent of those treated with ZEJULA and 26% treated with placebo had received prior bevacizumab therapy.

Approximately 50% of patients had 3 or more lines of treatment. The trial demonstrated a statistically significant improvement in PFS for patients randomized to ZEJULA as compared with placebo in the g BRCA mut cohort ( Table 11 and Figure 2 ). Table 11.

Efficacy Results – NOVA gBRCAmut Cohort (IRC Assessment a ) Figure 2. Progression-Free Survival – NOVA g BRCA mut Cohort Based on IRC Assessment (N = 203) g BRCA mut = germline BRCA -mutated; IRC = Independent Review Committee. A final OS analysis was conducted after 154 events were observed.

Figure 2

Table 10. Efficacy Results – PRIMA HRD-Positive Population Progression-Free Survival (PFS) a
HRD = Homologous Recombination Deficient; NE = Not Estimable.
a Efficacy analysis was based on blinded independent central review.
b Based on a stratified Cox proportional hazards model.
c Based on a stratified log-rank test.
	ZEJULA (n = 247)	Placebo (n = 126)
PFS events, n (%)	81 (33)	73 (58)
PFS median in months (95% CI)	21.9 (19.3, NE)	10.4 (8.1, 12.1)
Hazard ratio b (95% CI)	0.43 (0.31, 0.59)
P value c	<0.0001

Table 11. Efficacy Results – NOVA gBRCAmut Cohort (IRC Assessment a )
g BRCA mut = germline BRCA -mutated; IRC = Independent Review Committee; NR = Not Reached.
a Efficacy analysis was based on blinded central independent radiologic and clinical oncology review committee.
b Based on a stratified Cox proportional hazards model.
c Based on a stratified log-rank test.
	ZEJULA (n = 138)	Placebo (n = 65)
Progression-free survival median in months (95% CI)	21.0 (12.9, NR)	5.5 (3.8, 7.2)
Hazard ratio b (95% CI)	0.26 (0.17, 0.41)
P value c	<0.0001

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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