Skip to main content
. Author manuscript; available in PMC: 2022 Jan 1.
Published in final edited form as: Cancer J. 2021 Nov-Dec;27(6):465–475. doi: 10.1097/PPO.0000000000000554

Table 3.

Summary of published phase 2 and 3 trials of PARPi in pancreatic cancer.

Phase 2 trials
Author (Trial name) Design Stage Setting Drug Key Findings Ref
Kaufman Non-randomized phase 2 Advanced or metastatic

  • Progression after gemcitabine

  • Germline BRCA1 or BRCA2

 Olaparib ORR: 21.7%
DOR: 134 days
OS: 18.4 mos
PFS: 4.6 mos		 44
Shroff (RUCAPANC) Non-randomized phase 2 Locally advanced or metastatic

  • Progression after 1–2 lines of chemotherapy

  • Germline or somatic BRCA1 or BRCA2

 Rucaparib ORR: 15.8%
DCR: 31.6%		 45
Lowery Non-randomized phase 2 Locally advanced or Metastatic

  • Progression.

  • Germline BRCA1, BRCA2, or PALB2

 Veliparib ORR: 0%
mPFS: 1.7 mo
mOS: 3.1 mo		 47
O’Reilly Randomized phase 2 Locally advanced or metastatic

  • First Line

  • Germline BRCA1, BRCA2 or PALB2

 Gem/Cis +/− Veliparib (veliparib vs without)
ORR: 74.1% vs 65.2% (p=0.55)
DCR: 100% vs 78.3% (p=0.02)
mOS: 15.5 mos vs 16.4 mos (p=0.6)
mPFS: 10.1 mos vs 9.7 mos (p=0.73)
G3–4 heme toxicities: 48% vs 30%		 10
Javle Two parallel non-randomized phase 2 Metastatic

  • Second or Third Line DNA Damage Repair deficiencies other than BRCA mutations

 Olaparib ORR:
mOS: 9.9 mos
mPFS: 3.7 mos		 48
Reiss Non-randomized phase 2 Unresectable or metastatic Maintenance

  • Germline or somatic BRCA1 or BRCA2

 Rucaparib mPFS: 13.1 mos
mOS: 23.5 mos
DCR: 66.7%
DOR: 17.3 mos
ORR: 41.7%		 46
Phase 3 trials
Author (Trial Name) Design Stage Setting Drug Outcomes Ref
Golan (POLO) Randomized phase 3 Metastatic

  • Maintenance

  • Germline BRCA1 or BRCA2

 Olaparib vs placebo mPFS 7.4 mo vs 3.8 mo (HR 0.43 95%CI 0.35–0.82, p=0.004)
mOS 18.9mo vs 18.1 mo (HR 0.91 95% CI 0.56–1.46, p=0.68)
HRQOL between group difference −2.47 (95%CI −7.27 to 2.33) on 100-point scale		 24,49,50

mPFS = median progression-free survival, OS= median overall survival, HRQOL= health-related quality of life 95%CI = 95% Confidence Interval, ORR = objective response rate, DCR = disease control rate, G3–4 Heme toxicities = rates of grade 3 to grade 4 hematologic toxicity, gem= gemcitabine, cis= cisplatin. POLO HRQOL was assessed with the EORTC QLQ-C30 global health-related quality-of-life score. Javle study accepted DNA damage repair deficiencies: somatic BRCA variant, somatic or germline: ATM, PALB2, CHEK1, FANCA, BARD1, RAD50, and ARID1A.