PDAC

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)

1

2

3

4

5

6

7

8

9

10

11-14

Onvansertib 12 mg/m²

 

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

 

Eligibility Criteria
  • 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.