US-based clinical-stage biotechnology company Cardiff Oncology has announced positive initial data from its randomised Phase II clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
The Phase II trial (NCT06106308) has a primary endpoint of objective response rate (ORR) and secondary endpoints including progression-free survival (PFS), duration of response (DOR) and safety.
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There were 30 evaluable patients at the cut-off point (26 November), randomised in a 1:1:1 ratio. A third received 20mg of onvansertib alongside SoC, a third received 30mg alongside SoC and a third received only SoC.
The 30mg dose arm demonstrated 64% ORR, compared to 50% in the 20mg arm, and 33% ORR in the control arm. Deeper tumour regression was also noted in the 30mg arm of the study.
Fairooz Kabbinavar, chief medical officer of Cardiff Oncology, said of the results: “Our data shows an objective response rate of 64% in patients receiving the 30mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone.
“In addition, as can be seen in the spider plots, we are observing deeper tumour response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses.”
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By GlobalData
Cardiff Oncology also noted that onvansertib was well tolerated by colorectal cancer patients at both the 30mg and 20mg doses. It plans to share additional clinical data from the trial expected in the first half of 2025.
The company’s stock price jumped 50% on 10 December in response to the positive initial data, reaching $3.60. It has continued to climb, reaching $3.94 by today (11 December), a 64% jump compared to the evening of 9 December.
Following the results, the company has also announced the pricing of an underwritten offering of 15,384,619 shares of its common stock at an offering price of $2.60 per share, before deducting underwriting discounts and commissions. This totals an oversubscribed offering of approximately $40m.
On sharing the news, Cardiff Oncology said that it will use the net proceeds to fund clinical costs for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC), as well as for working capital and other general corporate purposes.
GlobalData records show that Cardiff Oncology is currently involved (either as a sponsor or collaborator) in six other ongoing studies considering onvansertib’s potential in oncology. These are:
- Collaborator: the study of onvansertib in relapsed small cell lung cancer (NCT05450965).
- Sponsor: the study of onvansertib in combination with nanoliposomal irinotecan, leucovorin, and fluorouracil for second-line treatment of participants with metastatic pancreatic ductal adenocarcinoma (NCT04752696).
- Sponsor: onvansertib in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab for second-line treatment of metastatic colorectal cancer in participants with a Kirsten Rat Sarcoma Virus Gene (KRAS) or neuroblastoma-RAS (NRAS) mutation (NCT05593328).
- Collaborator: onvansertib plus paclitaxel In TNBC (NCT05383196).
- Sponsor: Phase Ib/II study of onvansertib in pancreatic, ovarian, breast and small-cell lung cancer.
- Collaborator: targeted pathway inhibition in patients with pancreatic cancer (NCT04005690).
The company also sponsored four completed trials, all assessing the efficacy of onvansertib in oncological treatments.
GlobalData is the parent company of Clinical Trials Arena.
