Turning the Tide
On Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
New Second-Line Therapies are Needed for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Patients
- Second-line treatment with SOC irinotecan + 5-FU/leucovorin has a response rate of only 7.7%1
- Second-line treatment with SOC irinotecan + 5-FU/leucovorin offers a mOS benefit of only 6.1 months
- Mutant KRAS contributes to treatment resistance and metastases and is essential for PDAC growth
Leveraging the synergy of onvansertib combined with either irinotecan or 5-FU
The promising response rates and impressive durability seen in KRAS-mutated mCRC with the combination of onvansertib + irinotecan + 5-FU support onvansertib’s potential in PDAC, where ~95% of patients have a KRAS mutation.
Trial Design: Phase 2 Open Label Study of Onvansertib + Nanoliposomal Irinotecan + 5-FU in Metastatic PDAC
Trial Design (~ 45 patients):
1 CYCLE = 14 Days
Treatment Course (Days)
Onvansertib to be administered on days 1-10 (12 mg/m²) based on safety
lead-in of 6 patients (with option to dose 15 mg/m² on Days 1-5)
Nanoliposomal lrinotecan (nal-IRI) + 5-FU
- Prior abraxane/gemcitabine and no prior irinotecan, nanoliposomal irinotecan or investigational PLK1 inhibitor
Primary Efficacy Endpoint
- Objective response rate (ORR)
Our Clinical Programs
KRAS-Mutated Metastatic Colorectal Cancer (mCRC)
Combining onvansertib with FOLFIRI/Avastin® to improve efficacy by increasing duration of response and overall survival.
Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Leveraging the synergy of onvansertib to increase duration and response of overall survival.
Zytiga-Resistant Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Adding onvansertib to daily Zytiga® to overcome resistance, extend treatment response and overall survival.