Aveo gives up on ficlatuzumab in acute myeloid leukemia, citing COVID-19


Back in 2012, Aveo announced that its second most advanced asset, ficlatuzumab, had flopped in a midstage cancer test; for years, we heard nothing about this drug.

But ficlatuzumab, a hepatocyte growth factor inhibitory antibody (that is partnered with Biodesix), looked like it might be making a comeback when, almost exactly one year ago, the pair announced what it said were positive data out of a phase 1b trial for the med in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML).

At the time, the therapy was also in studies for squamous cell carcinoma of the head and neck (HNSCC), metastatic pancreatic ductal cancer and AML.

Virtual Roundtable

ASCO Explained: Expert predictions and takeaways from the world's biggest cancer meeting

Join FiercePharma for our ASCO pre- and post-show webinar series. We'll bring together a panel of experts to preview what to watch for at ASCO. Cancer experts will highlight closely watched data sets to be unveiled at the virtual meeting--and discuss how they could change prescribing patterns. Following the meeting, we’ll do a post-show wrap up to break down the biggest data that came out over the weekend, as well as the implications they could have for prescribers, patients and drugmakers.

But now, amid the growing COVID-19 pandemic that has seen major delays to nearly all trials for pharma and biotech, big and small, Aveo and Biodesix have said they are canning any more trials in AML, citing the virus’s spread and impact for its decision.

Specifically, the companies are halting work on their follow-up phase 2 CyFi-2 study that was assessing the drug alongside high-dose cytarabine versus high-dose cytarabine alone in patients with relapsed and refractory AML.

“This decision is being taken due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply. The study has not yet begun patient enrollment,” it said in a brief statement.

“While this is a difficult decision, as we remain optimistic about the potential of ficlatuzumab in AML, we believe it is necessary in light of the COVID-19 pandemic and its effect on the states where the CyFi-2 study was to take place,” said Michael Bailey, president and CEO of Aveo.

“Our investigators have been informed of the closure, and we greatly appreciate their enthusiasm for the study. We remain committed to the practice of scientific discovery and will focus our resources and efforts on our ongoing initiatives.”

The biotech said the drug is now being tested in just HNSCC.

Aveo has had a tortuous path with its leading drug, tivozanib, now Fotivda. After years of flops and setbacks in trials, it was finally approved in the EU in 2017 for kidney cancer, although the FDA has rejected the med in the past.

Suggested Articles

Insitro picked up $143 million to build out its technology, pursue new targets and advance treatments for genetically defined patient groups.

Generation Bio filed for a $215 million IPO to advance a pair of gene therapies for liver disease and push one of them into the clinic.

The IPO will push Avidity's lead muscle disorder program through IND-enabling studies and into the clinic in 2021.