CAMBRIDGE, Mass. (
(AVEO - Get Report)
will be presenting updated data on its kidney cancer drug tivozanib, including a more detailed look at overall survival, at a medical meeting next week. The new tivozanib data may help alleviate investor concerns about the drug's chance for FDA approval, although I suspect worries about tivozanib's commercial potential will linger.
Before Aveo can market tivozanib, FDA must approve, which is why the new data to be presented at the American Society of Clinical Oncology Genitourinary Symposium are important.
Embargoes on the new tivozanib data lift Tuesday, Feb. 12 at 6 pm, with the actual presentation scheduled for Feb. 16.
The most important presentation will be an update on two-year overall survival from the "TIVO-1" phase III study that compared tivozanib to Nexavar, marketed by
The only survival data presented previously from the study -- which has given Aveo headaches ever since -- showed one-year survival of 77% for tivozanib patients compared to 81% for Nexavar patients. The FDA raised concerns about this unfavorable survival trend, which naturally, set investors on edge.
At next week's ASCO GU meeting, we'll get more details on the final overall survival in both arms, including medians, the Kaplan-Meier curves, hazard ratio and p value. Certain patient subset analyses will also be presented.
Best case would be for the negative survival trend to reverse itself. Absent that (and I don't believe the survival benefit will tip in tivozanib's favor), the new data are more likely to address Aveo's argument that patient crossover skewed survival in Nexavar's favor.
What we know already is that more than 60% of the patients randomized to the Nexavar arm later received tivozanib or some other therapy upon tumor progression. These Nexavar crossover patients are living longer because they benefited from treatment with two active kidney cancer drugs, Aveo believes. Meantime, only 24% of patients chosen to begin the trial in the tivozanib arm went on to a subsequent therapy.
FDA is reviewing tivozanib with an approval decision date of July 28. An FDA advisory panel is expected to review the kidney cancer drug, although no date has been set. A May or June panel meeting is likely.