OC Trials Flashcards
What did the GOG-0218 and ICON7 trials show?
The GOG-0218 and ICON7 trials showed that first-line bevacizumab + chemotherapy, followed by maintenance bevacizumab, significantly increased progression-free survival (PFS) in newly diagnosed, advanced ovarian cancer when compared with first-line chemotherapy followed by placebo.
What was the HR for investigator-assessed median PFS results in the intention to treat population in the PAOLA-1 study?
0.59
What did the SOLO-1 trial show?
PARP inhibitor olaparib has a PFS benefit as a 1st-line maintenance therapy in patients with BRCAm1
What cohort did SOLO-1 look at?
Patients with newly diagnosed, advanced ovarian cancer, a BRCA mutation (BRCAm), and a complete or partial clinical response to platinum-based chemo
What was the trial design for PAOLA-1 (also called ENGOT-ov25)?
The first Phase 3 trial to assess the efficacy and safety of maintenance therapy with a PARP inhibitor (olaparib) + anti-angiogenic agent (bevacizumab) in patients with newly diagnosed advanced OC, regardless of BRCA mutation status, after receiving first-line
platinum-based standard of care chemo including bev.
Which patients were eligible to take part in PAOLA-1?
Newly diagnosed FIGO stage III or IV, high-grade ovarian cancer (serous or endometrioid) or non-mucinous BRCAm
What were the pre-requisites for eligibility to PAOLA-1?
Surgery (upfront or interval)
• CT + bev:
o Minimum 4 cycles of platinum + taxane (maximum 9 cycles)
o Minimum 3 cycles of bev, with last 3 cycles of CT
• No evidence of disease or CR or PR following 1L platinum-based chemotherapy
• ECOG PS 0-1
• Undergone tBRCAm testing
What was the PARPinh dosing in PAOLA-1?
Olaparib 300 mg twice daily (24 months) +
bev 15 mg/kg every 3 weeks (15 months in total)
What was the primary endpoint of PAOLA-1?
• Progression-free survival (PFS) in ITT population, as assessed by investigators (RECIST v1.1)
What were the secondary endpoints in PAOLA-1?
Time to first subsequent treatment (TFST)
• Progression-free survival 2 (PFS2; time to second
progression or death)
• Time to second subsequent treatment (TSST)
• Overall survival (OS)
• Health-related quality of life (HRQoL)
• Safety and tolerability
What were the investigator-assessed median PFS results in the intention to treat population in the PAOLA-1 clinical trial?
22.1 months with olaparib + bevacizumab vs 16.6 months with placebo +bevacizumab
In the entire study population, olaparib treatment reduced risk of disease progression or death by how much when compared to treatment with placebo?
41%
In the HRD positive and tumor BRCA-mutated subgroups, olaparib reduced that risk of death by how much?
HRD = 67% (HR 0.33 [95% CI: 0.25-0.45]) tBRCAm = 69% (HR 0.31 [95% CI: 0.20-0.47]), respectively
What was the most common Grade ≥3 adverse event in the PAOLA-1 trial that was higher in the olaparib + bevacizumab treatment arm than in the placebo + bevacizumab arm?
Anaemia
What percentage of patients in the olaparib + bevacizumab arm of the PAOLA-1 clinical trial had a tumour BRCA mutation (tBRCAm) at baseline?
30%
