Kevin Elias, MD, is a gynecologic oncologist at Cleveland Clinic. 

Dr Elias on Outcomes With Niraparib Maintenance Therapy in Ovarian Cancer

“The primary outcome was progression-free survival. For women randomized to niraparib, the chances of progression or death were reduced by 70%. It was a very positive study."

Kevin Elias, MD, the Lillian and Seth Harris Endowed Chair for Ovarian Cancer Research at the Cleveland Clinic, discussed key efficacy findings from the phase 3 PRIMA (NCT02655016) and NOVA (NCT01847274) trials, both of which evaluated the PARP inhibitor niraparib (Zejula) as maintenance therapy in patients with ovarian cancer.

Although these studies shared the same investigational agent, they differed in design, patient population, and disease setting, Elias noted. The PRIMA trial enrolled patients with newly diagnosed, high-grade serous or endometrioid ovarian cancer who achieved either a complete or partial response following first-line platinum-based chemotherapy, regardless of 

mutation or homologous recombination deficiency (HRD) status. Patients were randomized to receive niraparib 300 mg once daily or placebo, with progression-free survival (PFS) as the primary end point.

At the 5-year follow-up, long-term efficacy outcomes continued to favor niraparib maintenance therapy over placebo in patients with ovarian cancer. The 5-year PFS rate was 22% in the overall population compared with 12% in the placebo arm. This benefit was more pronounced among patients with HRD-positive disease, in which 35% of those treated with niraparib remained progression free at 5 years vs 16% with placebo. The safety profile for maintenance niraparib remained consistent with prior analyses, with no new safety signals observed over long-term follow-up. The incidence of myelodysplastic syndrome and acute myeloid leukemia was less than 2.5% overall, occurring in 2.3% of patients receiving niraparib and 1.6% of those on placebo.

In contrast, the NOVA trial examined niraparib in the recurrent disease setting, enrolling patients with platinum-sensitive recurrent ovarian cancer who had achieved a response to their most recent platinum-based regimen. Patients were randomly assigneda to receive niraparib at 300 mg daily or placebo. Patients were stratified by germline 

mutation status. As in PRIMA, PFS served as the primary end point. Elias emphasized that patients who received niraparib experienced a significantly longer PFS compared with those who received placebo across all analyzed subgroups. In the germline 

-mutated cohort, the median PFS was 21.0 months with niraparib vs 5.5 months with placebo (HR, 0.27; 95% CI, 0.17-0.41). Among patients without 

 mutations but whose with HRD-positive tumors, the median PFS was 12.9 months with niraparib vs 3.8 months with placebo (HR, 0.38; 95% CI, 0.24-0.59). In the overall non-

-mutated cohort, which included both HRD-positive and HRD-negative patients, the median PFS was 9.3 months with niraparib compared with 3.9 months with placebo (HR, 0.45; 95% CI, 0.34-0.61; 

 < .001 for all comparisons). These results demonstrate a consistent and statistically significant PFS advantage with niraparib maintenance therapy across genomic subgroups, including patients without germline 

Taken together, PRIMA and NOVA established niraparib as an effective maintenance option across multiple disease settings in ovarian cancer, Elias underscored. Although the benefit is most pronounced in 

-mutated and HRD-positive populations, the observed efficacy in HRD-negative subgroups supports a more inclusive therapeutic role for PARP inhibition, he concluded.

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Kevin Elias, MD, discusses efficacy data from the PRIMA and NOVA trials evaluating niraparib as maintenance therapy in ovarian cancer.

elias

“Olaparib is still one of our treatments of choice for women with somatic or germline BRCA mutations who have just finished primary therapy. We have the longest [follow-up for] safety and efficacy data with olaparib compared with other PARP inhibitors, and we know that for this subgroup of patients, the benefit [with olaparib] is tremendous.”

Kevin Elias, MD, the Lillian and Seth Harris Endowed Chair for Ovarian Cancer Research at the Cleveland Clinic, emphasized the foundational role of olaparib (Lynparza) as maintenance therapy for patients with advanced ovarian cancer harboring somatic or germline BRCA1 or BRCA2 mutations following completion of primary therapy.

Among available PARP inhibitors, olaparib has the most mature safety and efficacy data, with durable benefit demonstrated through long-term follow-up.
Elias referenced the 7-year overall survival (OS) data from the phase 3 SOLO-1 trial (NCT01844986), which solidified olaparib’s role in this population. At 7 years from randomization, the risk of death was 33% among patients who received maintenance olaparib vs 53.5% among those who received placebo. Nearly half of patients treated with olaparib remained alive and recurrence-free at seven years, compared with only 20% of patients in the placebo arm who remained progression-free or alive during that period. These findings underscore the sustained benefit of early PARP inhibition in prolonging disease control and survival for patients with BRCA-mutated ovarian cancer, Elias said.

Elias noted that these data reinforce the clinical imperative of comprehensive molecular testing at diagnosis to identify patients who are most likely to derive benefit from targeted maintenance therapy. Determining BRCA1 and BRCA2 status—whether germline or somatic—early in the disease course enables prompt initiation of olaparib and ensures that eligible patients receive optimal therapy without unnecessary delay, Elias explained. Molecular stratification has therefore become integral to personalized treatment planning in ovarian cancer, aligning therapeutic decisions with underlying genomic drivers of disease, he stated.

From a clinical practice perspective, Elias highlighted that maintenance olaparib substantially alters the treatment trajectory for patients with BRCA-mutated disease. Across trials, olaparib maintenance has consistently reduced the risk of recurrence or death by more than 50% compared with placebo. He noted that these results provide strong justification for incorporating olaparib early in the management algorithm, particularly for patients who achieve a complete or partial response with platinum-based chemotherapy.

Elias concluded that the long-term survival advantage, established safety profile, and durable disease control observed with olaparib confirm its role as a cornerstone therapy in advanced ovarian cancer.

Kevin Elias, MD, discusses the role of olaparib maintenance therapy for patients with BRCA1 and BRCA2-mutated ovarian cancer.

Dr Elias on the Role of Olaparib Maintenance Therapy For BRCA1/2-Mutated Ovarian Cancer

Dr Elias on Efficacy Data With Olaparib in BRCA-Mutated Ovarian Cancer

“[In SOLO-1] the primary outcome was progression-free survival (PFS), and for women randomized to olaparib, the chances of progression or death were reduced by 70%... In SOLO-2, PFS in the olaparib group was 19 months vs 5.5 months in the placebo group.”

Kevin Elias, MD, a gynecologic oncologist at the Cleveland Clinic, discussed pivotal efficacy findings from the phase 3 SOLO-1 (NCT01844986) and SOLO-2 (NCT01874353) trials, which evaluated the use of olaparib (Lynparza) as maintenance therapy in patients with 

-mutated ovarian cancer. These landmark studies collectively established the role of PARP inhibition in extending progression-free survival (PFS) across both frontline and recurrent disease settings.

SOLO-1 enrolled patients with newly diagnosed, high-grade serous or endometrioid ovarian cancer who had achieved a complete or partial response following first-line platinum-based chemotherapy. Eligible patients carried either a germline or somatic 

mutation. Patients were randomly assigned 2:1 to receive olaparib at 300 mg twice daily or placebo for up to 2 years or until disease progression. The trial’s primary end point was PFS.

Elias highlighted that at the time of analysis, 67.0% of patients treated with olaparib vs 46.5% of patients treated with a placebo were alive. The magnitude and durability of benefit observed in SOLO-1 firmly positioned olaparib as a standard-of-care option for eligible patients following completion of platinum-based chemotherapy.

In contrast, SOLO-2 evaluated olaparib in patients with platinum-sensitive, relapsed ovarian cancer harboring germline 

 mutations. All enrolled patients had received at least 2 prior lines of platinum-based chemotherapy and were required to have achieved a response to their most recent regimen. Similar to SOLO-1, patients were randomized to olaparib at 300 mg twice daily or placebo, with PFS as the primary end point. In SOLO-2 at 5 years, 28.3% of patients in the olaparib arm vs 12.8% of patients in the placebo arm were alive and had still not received subsequent treatment. In total, 42.1% of olaparib patients vs 33.2% of placebo patients were alive at the study’s conclusion.

Elias emphasized that both SOLO trials provided consistent evidence supporting olaparib as an effective maintenance strategy for patients with 

mutated ovarian cancer, whether in the newly diagnosed or recurrent setting. Together, these studies established the clinical rationale for early incorporation of PARP inhibition into treatment paradigms and underscored the durable disease control achievable through targeted maintenance therapy.

Kevin Elias, MD, discusses the SOLO-1 and SOLO-2 trials, which evaluated olaparib in newly diagnosed and relapsed BRCA-mutated ovarian cancer.

Kevin Elias, MD

Articles

Dr Elias on Outcomes With Niraparib Maintenance Therapy in Ovarian Cancer

Dr Elias on the Role of Olaparib Maintenance Therapy For BRCA1/2-Mutated Ovarian Cancer

Dr Elias on Efficacy Data With Olaparib in BRCA-Mutated Ovarian Cancer