Recent Data Updates from PRIMA and PAOLA-1 Trials in Ovarian Cancer
Key takeaways from recent data updates from the PRIMA and PAOLA-1 trials investigating PARP inhibitors in ovarian cancer.
Case: A 49-Year-Old Woman with BRCA-WT Ovarian Cancer
- A 49-year-old presented to her primary care physician complaining of abdominal bloating and nausea
- PMH: mild HTN
- FH: mother died of breast cancer at age 59; cousin on mother’s side died of ovarian cancer at age 65
- Imaging: CT reveals small-volume ascites, bilateral 8-cm adnexal masses
- Labs: CA 125, 285 U/mL
- Surgical intervention: she underwent exploratory laparotomy followed by omentectomy, bilateral salpingo-oophorectomy, and resection of peritoneal nodules; optimal cytoreduction with < 1 cm of residual disease after surgery
- Diagnosis: stage IIIC HGSC
- Treatment: She was treated with IV carboplatin and paclitaxel w/ NK1, 5HT3, and dexamethasone CINV prophylaxis
- TRAEs: She experienced persistent daily nausea with vomiting on day 1 after chemotherapy
- Follow-up: After completion of chemotherapy, CA 125, 14.2; clinically NED; patient reports continuing daily nausea
Transcript:
Chad A. Hamilton, MD: I don’t think it’s hyperbolic to say that we’re approaching a time where some form of maintenance therapy may be appropriate for all patients in frontline treatment. It has been very reassuring to see the subsequent presentations and publications from these initial trials that I mentioned. An update to the [phase 3] PRIMA trial [NCT02655016] was presented at ESMO [European Society for Medical Oncology Congress] in 2022, and this presented the long-term progression-free survival [PFS] data with a median follow-up of 3 and a half years, which was double the follow-up from the initial trial. And this confirmed a sustained benefit of niraparib, reducing the rate of progression or death by 48% in patients with HRD [homologous recombination deficiency-positive] tumors with a median progression-free survival just over 2 years vs 11 months in the placebo group. And this PFS benefit was also confirmed in the overall population, with a reduction in risk of progression of 34% in that group.
Similarly, there was an update at ESMO on the [phase 3] PAOLA-1 trial [NCT02477644] data. And they actually have long enough follow-up to present their final overall survival data. This was actually just recently published as well this year. In their HRD population, their 5-year overall survival was just over 65% for the olaparib plus bevacizumab group vs 48% for the placebo plus bevacizumab, which was a 38% reduction in risk of death. And again, the updated progression-free survival also demonstrated a higher proportion of patients without relapse. And that was a 59% reduction in risk of relapse. In PAOLA-1, the bottom line is a sustained benefit in that HRD-positive population.
Transcript is AI-generated and edited for clarity and readability.
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