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
| Total: 50
|
|
| 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 |
| Total: 154
|
|
| 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.