NOVA trial was designed to examine the efficacy of niraparib maintenance therapy

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Phase 3 NOVA Trial

High-Grade Serous Ovarian Cancer, Platinum Sensitive, Relapsed

Response to Last Platinum Treatment (n=553)

Defined as:

  • Complete response OR
  • Partial response with residual disease <2 cm and CA-125 values either within the normal range, or a CA-125 decrease of >90% that was stable for ≥7 days


Germline BRCA positive (n=203)

 

2:1 Randomization

Germline BRCA negative (n=350)

myChoice HRD assessed in this cohort

2:1 Randomization

Niraparib 300mg

Maintenance Therapy

Placebo

 

Niraparib 300mg (n=234)

 

Placebo (n=116)

Maintenance Therapy


Endpoint Assessment

Primary Endpoint PFS


Endpoint Assessment

Primary Endpoint PFS

*Defined as a 50% reduction in CA-125

Piccart et al. JNCI. (2000). 92(9):699-708.
Du et al. Oncology Letters. (2016). 12:857-862.
Rose et al. J Clin Oncol. (1998). 16(2):405-410.
Gore et al. Gynecol Oncol. (1990). 36(2):207-11.
Gonzalez-Martin et al. Ann Oncol. (2005). 16(5):749-55.

NOVA Companion Diagnostic Prolonged PFS Benefit
(Niraparib vs. Placebo)
Hazard Ratio (95% Cl) P-Value
Germline BRCA Positive BRACAnalysis CDx® positive (n=203) 15.5 months
(21.0 vs. 5.5 months)
0.27
(0.17-0.41)
<0.001
Germline BRCA Negative Overall germline BRCA negative cohort (n=350)
(myChoice® HRD positive and negative)
5.4 months
(9.3 vs. 3.9 months)
0.45
(0.34-0.61)
<0.001
myChoice® HRD positive (n=162) 9.1 months
(12.9 vs. 3.8 months)
0.38
(0.24-0.59)
<0.001
myChoice® HRD negative (n=134) 3.1 months
(6.9 vs. 3.8 months)
0.58
(0.36-0.92)
0.02
Somatic BRCA positive (n=47) 9.9 months
(20.9 vs. 11.0 months)
0.27
(0.24-0.59)
0.02

Olaparib was Well Tolerated with a Lower Grade ≥3 Adverse Event Rate than Standard Therapy

Percent of Patients Experiencing Grade ≥3 Adverse Events

Mirza et al. N Engl J Med. (2016). 375:2154-2164.