Skip to main content
. 2020 Aug 27;70(3):606–617. doi: 10.1136/gutjnl-2019-319984

Table 5.

Clinical trials with PARP inhibitors on patients with advanced PDAC

Mutations Design Therapy line Therapy Number of pts. mPFS mOS Efficacy Reference Abstract-based publication
gBRCA1/2 Phase I First-line Cisplatin
Gemcitabine
Veliparib		 Total: 17
HRD: 9
HRP: 7
Unknown: 1		 n.a. HRD: 23.3 m
HRP: 11 m		 n.a. 102 No
gBRCA1 (n=12)
gBRCA2 (n=35)
gPALB2 (n=3)		 Phase II First-line Cisplatin
Gemcitabine

  1. +Veliparib

  2. − Veliparib

 Total: 50

  1. 27

  2. 23

  1. 10.1 m

  2. 9.7 m

  1. 15.5 m

  2. 16.4 m

 mPFS: p=0.73
mOS: p=0.6		 86 Yes
gBRCA1/2 (n=16)
sBRCA1/2 (n=3)		 Phase II ≥Second-line Rucaparib Total: 19 n.a.* n.a.* n.a.* 95 No
gBRCA1 (n=5)
gBRCA2 (n=11)		 Phase II ≥Second-line Veliparib Total: 16
HRD: 9
HRP: 7		 1.7 m 3.1 m n.a. 97 No
gBRCA1 (n=5)
gBRCA2 (n=17)
gBRCA1/2 (n=1)		 Phase II ≥Second-line Olaparib Total: 23 4.6 m 9.8 m n.a. 96 No
DDR mutation (eg, BRCA1/2, PALB2, ATM) Phase I/II Various mFOLFOX
Veliparib		 Total: 57
HRD: 16
HRP 41		 HRD: 7.2 m
HRP: 3.5 m		 HRD: 11.1 m
HRP: 6.8 m		  n.a. 99 Yes
gBRCA1 (n=3)
gBRCA2 (n=13)
gPALB2 (n=2)
sBRCA2 (n=1)		 Phase II First-line maintenance after platinum induction Rucaparib Total: 19 9.1 m n.a. n.a. 101 Yes
gBRCA1 (n=45)
gBRCA2 (n=108)
gBRCA1/2 (n=1)		 Phase III First-line maintenance after platinum induction

  1. Olaparib

  2. Placebo

 Total: 154

  1. 92

  2. 62

  1. 7.4 m

  2. 3.8 m

  1. 18.9 m

  2. 18.1 m

 mPFS: p=0.004
mOS: p=0.91		 100 No

*As prespecified in the protocol, enrolment was stopped because of an insufficient response rate among the first 15 patients.

FOLFOX, folinic acid, fluouracil, oxaliplatin; HRD, homologous recombination-deficient; HRP, homologous recombination-proficient; m, month; mOS, median overall survival; mPFS, median progression-free survival; n.a., not applicable; pts., patients.