The addition of Bristol Myers Squibb’s Opdivo to a low dose of Aveo Oncology’s Fotivda failed to extend the time before tumor progression or death in kidney cancer patients who had tried an immune checkpoint inhibitor (ICI).

AVEO Oncology has agreed to an acquisition by Korean firm LG Chem for $566M in an all-cash deal. The offering price of $15.00/share represents a 43% premium over AVEO's closing price on Monday, October 17, 2022. Upon completion of the transaction, AVEO will establish and operate as the U.S. commercial foundation for LG Chem Life Sciences’ oncology segment. 

The U.S. Food and Drug Administration (FDA) approved AVEO Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma (RCC) in people who have had two or more previous systemic therapies. The FDA’s decision comes over three years after the European Union approved the drug in August 2017.

Aveo Oncology has regained the full global rights to ficlatuzumab. Biodesix was co-developing the hepatocyte growth factor inhibitory antibody with Aveo but has chosen to exercise its opt-out right before the program moves into phase 3.

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).

In a "Groundhog Day" scenario, the FDA has once more slapped down Aveo Oncology’s attempt to get its ill-fated cancer drug on the U.S. market.

The U.S. regulator outright refused to approve the drug, known as tivozanib, all the way back in 2013, but Aveo has kept plugging away, with no success.

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults as about nine out of 10 kidney cancer patients are diagnosed with it. Per statistics, approximately 403,000 cases of kidney cancer were diagnosed worldwide in 2018 and about 175,000 deaths occurred due to the disease.

When Aveo Oncology scored European approval in 2017 for its lead cancer drug tivozanib — despite the treatment’s chequered past — a comeback story was in the making. New pivotal data could now threaten that approval, and the company’s investors are losing patience.

Shares of Cambridge, Mass.-based AVEO Oncology have taken a wild ride over the past day. The stock skyrocketed more than 45 percent Wednesday on rumors of a possible acquisition. However, overnight and in premarket trading, the stock has lost about 5 percent of its gains.