- Aveo Oncology said it would end Phase 2 trials of its lung cancer drug and second most advanced clinical candidate ficlatuzumab, revealing the shift Monday in a regulatory filing.
- Higher-than-expected discontinuation rates among patients in the trial "significantly compromised" the ability of Aveo to continue testing, according to the release.
- Ficlatuzumab, a HGF inhibitory antibody, was being tested in combination with Roche's Tarceva among patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Aveo has been doing its best to put its past problems behind it. In March, the Cambridge-based oncology company settled fraud charges brought against it by the SEC for allegedly concealing negative responses from the Food and Drug Administration over the development path of its lead kidney cancer drug.
The FDA rejected the drug, called tivozanib, in June 2013 and recommended Aveo carry out further clinical testing. Prior to receipt of the complete response letter from the agency, however, Aveo had been informed in May 2012 that an additional study would be needed, according to the SEC charges.
Aveo allegedly failed to appropriately disclose this fact to investors, and raised $53 million in a public stock offering in January 2013 with investors in the blind.
Now under new management, Aveo is finally trying to move forward with that additional study. A Phase 3 trial of tivozanib in third-line renal cell carcinoma (RCC) began dosing in May and Aveo was able to lock in $17 million in new funding through a private placement.
Aveo also signed a collaboration deal with Bristol-Myers Squibb to test tivozanib in combination with Opdivo (nivolumab) among RCC patients.
But the company has a long road back, currently trading in penny-stock territory. And the setback for ficlatuzumab depletes a thin bench of clinical candidates.