Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

Trial ID # NCT02477644; PAOLA
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Bevacizumab, Carboplatin, Olaparib, Paclitaxel
Eligible Participant

Stage III or IV, high grade serous or endometrioid, with CR or PR after first-line chemotherapy+bevacizumab

Patients Enrolled

806

Therapy Setting

Maintenance

Study Design

Double Blind, Randomized

Endpoints

PFS, evaluated per RECIST

Biomarkers

Exploratory: BRCA status, HRD status

Efficacy

Ola vs Placebo:

All patients:
PFS: 22.1 vs 16.6 months, HR: 0.59 (0.49-0.72, p<0.0001)

Exploratory analyses:
BRCA MUT (n=237): PFS: 37.2 vs 21.7 months, HR: 0.31 (0.20-0.47)
HRD-pos (incl BRCA MUT) (n=387): PFS: 37.2 vs 17.1 months, HR: 0.33 (0.25-0.45)
HRD-pos (excl BRCA MUT) (n=152): PFS: 28.1 vs 16.6 months, HR: 0.43 (0.28-0.66)
non-BRCA MUT (n=569): 18.9 vs 16.0 months,  HR: 0.71 (0.58-0.88)
HRD-neg (n=419): 16.9 vs 16.0 months, HR: 0.92 (0.72-1.17)

Clinically Significant Adverse Events

Ola vs Placebo:
Serious AE:
Grade 3-4 AE:

Conclusion

Dual maintenance therapy with olaparib and bevacizumab significantly improves PFS compared with bevacizumab maintenance alone

Reference

Ray-Coquard IL et al. Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (pts) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev. ESMO (2019) Abstr LBA2_PR
https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal/presentation/list?q=PAola