On September 26, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported positive clinical data with onvansertib monotherapy and combination therapy in our ongoing trials in metastatic pancreatic ductal adenocarcinoma (mPDAC) and small cell lung cancer (SCLC), as well as plans for a mPDAC first-line investigator-initiated trial (IIT) of the combination of onvansertib plus standard-of-care (SoC) (Press release, Cardiff Oncology, SEP 26, 2023, View Source [SID1234635405]).

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"We are excited that the data released from these trials, in two challenging cancers with low survival rates, expands the opportunity for onvansertib beyond our lead program in RAS-mutated mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "In pancreatic cancer, the strength of the data provides a clear rationale for a first-line trial using onvansertib in combination with standard of care, which we believe provides the greatest opportunity for a positive impact on patients. In small cell lung cancer, we are encouraged to observe single-agent activity with onvansertib monotherapy in this difficult-to-treat extensive stage refractory setting."
mPDAC Phase 2 CRDF-001 trial: 19% ORR and 5.0-month mPFS

Data from the ongoing Phase 2 open-label trial of onvansertib combined with nanoliposomal irinotecan, leucovorin, and 5-FU in patients with second-line mPDAC demonstrated an objective response rate (ORR) of 19% (4 of 21 evaluable patients; 1 confirmed PR, 3 waiting for confirmatory scan) and median progression-free survival (mPFS) of 5.0 months as of the data cutoff of September 13, 2023. Historical control trials in similar patient populations have shown an ORR of 7.7% and mPFS of 3.1 months with SoC.

mPDAC biomarker discovery trial: decrease in clinically-validated tumor biomarkers from onvansertib monotherapy
The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and is currently enrolling at the Oregon Health & Science University (OHSU) Knight Cancer Institute. Two patients have been enrolled to date. One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response.

"Serum carbohydrate antigen 19-9 is the most extensively studied and validated serum biomarker in PDAC, which provides a clinically meaningful surrogate for response to treatment. We are encouraged by the ability of onvansertib to provide an approximately 30% reduction in this biomarker with only 10 days of monotherapy in a refractory setting," said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. "We will continue to explore onvansertib in the first-line mPDAC investigator-initiated trial at the OHSU Knight Cancer Institute."

Update in Clinical Development Plan for mPDAC

The next trial in mPDAC will be a new Phase 2 investigator-initiated trial at OHSU Knight Cancer Institute in mPDAC in the first-line setting. There are two cohorts in this trial. In cohort 1, patients will receive the combination of onvansertib with SoC (Gemzar + Abraxane). In cohort 2, patients will receive 10 days of onvansertib monotherapy followed by onvansertib + SoC to identify biomarkers that predict response to onvansertib.

SCLC Phase 2 Investigator-Initiated Trial

The ongoing Phase 2 trial of onvansertib monotherapy in patients with relapsed extensive stage SCLC who have received up to two prior therapies is currently enrolling patients at the University of Pittsburgh Medical Center. An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data in evaluable patients will be discussed on the company conference call.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast at 5:00 p.m. ET/2:00 p.m. PT on September 26, 2023. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website for 30 days following the completion of the call.