Cardiff’s stock jumps after sharing promising PhII data for its PLK1 inhibitor onvansertib in pancreatic cancer

Cardiff Oncology saw its stock rise after it announced positive Phase II data from its PLK1 inhibitor onvansertib in second-line metastatic pancreatic ductal adenocarcinoma (mPDAC), spurring plans for an investigator-led trial in first-line treatment.

The San Diego-based company’s stock price $CRDF rose by 25% post-market to $2.03 in response to the Tuesday update, easing to about $1.70 on Wednesday.

Cardiff’s open-label Phase II trial is evaluating onvansertib plus the standard of care regimen of Ipsen’s Onivyde, leucovorin and chemotherapy in second-line mPDAC.

Onvansertib plus the standard of care reached a 19% objective response rate (ORR) in 21 evaluable patients and had a median progression-free survival (mPFS) of five months as of the Sept. 13 data cut-off.

William Blair analysts highlighted that the ORR was higher than the 7.7% confirmed response rate for Onivyde plus leucovorin and chemotherapy as seen in historical control trials, with the caveat that just one of four responses in Cardiff’s trial was confirmed.

TD Cowen analysts remarked that the Phase II second-line results fall short of Cardiff’s target of a 20% overall response rate and six months of mPFS. “We view these values as generally comparable,” they wrote.

Fairooz Kabbinavar

The ORR “comes very close to the frontline historical 33% objective response rate of Gemzar-Abraxane,” Cardiff’s chief medical officer, Fairooz Kabbinavar, said in a company call on Tuesday.

These data propelled investigators at the OHSU Knight Cancer Institute to plan to evaluate onvansertib in a new Phase II trial in first-line mPDAC, with the aim of identifying biomarkers that can predict a response to Cardiff’s drug.

The first-line study will comprise two cohorts of first-line patients, with one receiving onvansertib plus the chemotherapy combo gemcitabine and nab-paclitaxel. The second cohort will get onvansertib alone, followed by the same chemo combo.

But Cowen analysts warned that combining onvansertib with a nab-paclitaxel-based regimen in the first-line setting carries some clinical risk. The other standard first-line therapy is the chemo cocktail FOLFIRINOX, which “more closely resembles” the second-line Onivyde regimen.

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