Dr. Gonzalez-Martin on Rationale for Phase III PRIMA Trial in Advanced Ovarian Cancer

Antonio Gonzalez-Martin, MD
Published: Monday, Oct 21, 2019



Antonio Gonzalez-Martin, MD, co-director, Department of Medical Oncology, Clinica Universidad de Navarra, discusses the rationale for the phase III PRIMA trial investigating niraparib (Zejula) as maintenance therapy for patients with platinum-sensitive advanced ovarian cancer. 
 
The majority of patients with advanced ovarian cancer will relapse shortly after completing chemotherapy, says Gonzalez-Martin. Although there are maintenance therapy options, not all patients will benefit from them, he adds.
 
In the recurrent setting, niraparib has shown an improvement in progression-free survival (PFS) in platinum-sensitive patients regardless of BRCA status or homologous recombination deficiency (HRD) status. Therefore, PRIMA was designed to evaluate niraparib as frontline maintenance therapy in patients with high-risk of relapse. 
 
In the overall population, the median progression-free survival (PFS) was 13.8 months in the niraparib arm compared with 8.2 months in the placebo arm (HR, 0.62; 95% CI, 0.50-0.76; P <.001). Notably, HRD-positive patients had a median PFS of 21.9 months with niraparib versus 10.4 months with placebo (HR, 0.43; 95% CI, 0.50-0.76; P <.001). 
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Antonio Gonzalez-Martin, MD, co-director, Department of Medical Oncology, Clinica Universidad de Navarra, discusses the rationale for the phase III PRIMA trial investigating niraparib (Zejula) as maintenance therapy for patients with platinum-sensitive advanced ovarian cancer. 
 
The majority of patients with advanced ovarian cancer will relapse shortly after completing chemotherapy, says Gonzalez-Martin. Although there are maintenance therapy options, not all patients will benefit from them, he adds.
 
In the recurrent setting, niraparib has shown an improvement in progression-free survival (PFS) in platinum-sensitive patients regardless of BRCA status or homologous recombination deficiency (HRD) status. Therefore, PRIMA was designed to evaluate niraparib as frontline maintenance therapy in patients with high-risk of relapse. 
 
In the overall population, the median progression-free survival (PFS) was 13.8 months in the niraparib arm compared with 8.2 months in the placebo arm (HR, 0.62; 95% CI, 0.50-0.76; P <.001). Notably, HRD-positive patients had a median PFS of 21.9 months with niraparib versus 10.4 months with placebo (HR, 0.43; 95% CI, 0.50-0.76; P <.001). 

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