Clinical trialsCompany release

Cardiff Oncology: onvansertib Phase 2 PFS not yet reached; Phase 3 could start Q1 2027

🇺🇸 Cardiff Oncology, Inc. (CRDF) · Thu 12 Nov 2026

The US biotech says median progression-free survival has not been reached with 30 mg onvansertib plus FOLFIRI/bev in first-line RAS-mutated metastatic colorectal cancer, and it is preparing a registrational trial.

Cardiff Oncology reported third-quarter 2026 results and a business update on 12 November, headlined by data from its randomised Phase 2 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC).

According to the company, median progression-free survival (PFS) has not yet been reached in patients given 30 mg onvansertib with FOLFIRI and bevacizumab. In the combined standard-of-care control arms, median PFS was about 11 months.

Cardiff Oncology said it is preparing a registrational Phase 3 trial, which could begin in the first quarter of 2027. The summary provided does not give design details, such as endpoints, sample size or regulatory feedback, so these remain unconfirmed.

The company also said it resolved its licensing dispute with Nerviano in September. It reported cash of $33.8 million, which it expects to fund operations into the end of the third quarter of 2027.

As median PFS has not been reached, the Phase 2 result is still immature and may change as follow-up continues.

What it means for your team

  • Regulatory teams should watch for details of the Phase 3 design and any agency feedback, as none are given in this update.
  • Market-access and HTA observers should note that the Phase 2 PFS comparison is immature and based on a randomised trial, with the control benchmark at about 11 months.
  • The Nerviano dispute is described as resolved, which removes one licensing uncertainty around the asset.
  • Cash runway into the end of Q3 2027 could shape the timing and financing of the planned Phase 3.

Company's press release (SEC filing): Cardiff Oncology, Inc. ↗

Article written by VigiEye from the official source (Cardiff Oncology, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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