- Addition of the PARP inhibitor veliparib to gemcitabine plus cisplatin did not improve response rates and caused more hematologic toxicity in patients with pancreatic cancer with BRCA or PALB2 mutations.
Why this matters
- Nearly 1 in 10 pancreatic cancer patients have one of these mutations.
- The activity of PARP inhibitors has been demonstrated in these patient populations.
- Randomized, controlled phase 2 study of 52 treatment-naïve patients with locally advanced or metastatic pancreatic ductal adenocarcinoma treated with gemcitabine+cisplatin (GC, n=23) or GC+veliparib (GC+V, n=27).
- 94% had a BRCA mutation and 6% a PALB2 mutation.
- Primary endpoint was response rate.
- Funding: Lustgarten Foundation, the David M. Rubenstein Center for Pancreatic Cancer Research, the Reiss Family Foundation, the National Cancer Institute’s Cancer Therapy Evaluation Program, and NCI grants.
- Response rate for the GC arm was 65.2% vs 74.1% for the GC+V (P=.55).
- Disease control rates were 78.3% for the GC arm vs 100% for the GC+V arm (P=.02)
- Median PFS was 9.7 months for the GC arm vs 10.1 months for the GC+V arm (P=.73)
- Median OS was 16.4 months for the GC arm vs 15.5 months for the GC+V arm (P=.6)
- Hematologic toxicity was higher in the GC+V arm; non-hematologic toxicity was similar between arms.
- Small sample size.
Dr Richard L Schilsky, MD, Chief Medical Officer and Executive Vice President of ASCO said of the results, “Seeing response rates of 60% and 70% in patients with metastatic pancreatic cancer is kind of unprecedented, and that’s quite remarkable.”