it had data showing that tivozanib met the primary goal of its study by keeping tumors from spreading longer than sorafenib. Specifically, tivozanib kept tumors in check for a median time of 11.9 months, compared with 9.1 months for those randomly assigned the drug from Onyx/Bayer.
Secondly, it strongly touted tivozanib’s tolerability, noting that fewer patients were reporting side effects such as skin rash and diarrhea. Robert Motzer, a kidney cancer expert at Memorial Sloan-Kettering Cancer Center in New York, vouched for that tolerability profile, calling it “second to none” in the field of approved drugs for this particular set of patients.
That didn’t sway the panel, however, and Aveo executives at the hearing admitted they made a mistake designing their study.
“We did think it would have some impact on overall survival, but we did not anticipate that would be a bad thing,” said Bill Slichenmyer, Aveo’s chief medical officer, said of the crossover design. “It had a bigger impact than we had anticipated.”
Aveo executives also explained that at the time it began its study, there were several other trials with the same patient population going on in the U.S., so Aveo needed to look to other parts of the world where it could enroll patients for the study.
That decision, however, came back to haunt Aveo on Thursday.
The vote is a big setback for a company that has been driving 11 years of R&D towards this one moment and has yet to put a drug on the market.
Tivozanib is a once-daily pill that works by cutting the blood flow to tumors. It does so by blocking the three types of VEGF receptors, which are markers on the surface of cancer cells. Aveo has been hoping to bring tivozanib into crowded field that includes sorafenib, Pfizer’s sunitinib (Sutent) and axitinib (Inlyta), GlaxoSmithKline’s pazopanib (Votrient), and Roche/Genentech’s bevacizumab (Avastin).
