Earlier this week, AVEO Oncology (AVEO) and Astellas Pharma Inc.(TSE: 4503) announced new data from the Phase III TIVO-1 trial, and we asked the company to provide more insight into its presentation at ESMO 2012 Congress.
BioMedReports: You announced tivozanib efficacy data compared to Nexavar (sorafenib) from the TIVO-1 trial in June at ASCO. How does the TIVO-1 safety data presented at ESMO provide more perspective into tivozanib? How do these results compare to other treatments in the category?
Michael Bailey, Chief Commercial Officer at AVEO Oncology: To put this into perspective, Phase III efficacy data from TIVO-1 presented at ASCO earlier this year demonstrated a statistically significant improvement in progression free survival (NYSE:PFS) for tivozanib compared with sorafenib in treatment-naïve metastatic renal cell carcinoma (RCC) patients. A median PFS of 12.7 was demonstrated for tivozanib versus 9.1 months for sorafenib (p=0.037; HR=0.75). In the absence of head-to-head studies with other agents, direct comparisons cannot be made. However, based on these results, tivozanib is the only agent to demonstrate a median PFS of greater than a year in patients who were treatment naive for metastatic disease.
Now we have a detailed safety analysis from TIVO-1 that shows that patients treated with tivozanib experienced fewer Grade 3 and off-target adverse events, stayed on treatment longer, and required fewer dose reductions and interruptions compared with sorafenib. So together these results mean that tivozanib, an investigational therapy, is the first agent to demonstrate the unique combination of superior PFS and favorable tolerability in a pivotal study for advanced RCC versus an approved targeted agent.
Q: I see that progression free survival data is included in these results. When will overall survival data from this study be available?
Bailey: We're looking forward to sharing the OS results in the coming months at the appropriate venue, including scientific forums.
Q: Now that efficacy, safety and tolerability data from TIVO-1 are public, can you provide me with a full picture of what this data set means for patients with renal cell carcinoma?
Bailey: Minimizing toxicities from treatment while maintaining efficacy is still a significant concern for clinicians and RCC patients because adverse events may prevent patients from benefiting from the full effect of their medications. With fewer side effects and lower rates of dose modification compared to sorafenib, these results suggest that tivozanib, if approved, may provide an option to maintain full dose therapy while still providing efficacy. We believe tivozanib could be an important advancement in kidney cancer treatment.
Q: You submitted an NDA filing for tivozanib in metastatic renal cell carcinoma with the FDA last week. When do you expect to receive NDA filing acceptance?
Bailey: Yes, we recently announced the NDA submission for tivozanib in advanced RCC. At this time, the FDA has not notified us regarding acceptance of the submission, but the goal for the FDA is to respond within 60 days of the submission.
Q: You just enrolled the first patient in your patient preference study called TAURUS. Can you give me a brief overview of how it's set up and what we can expect to see out of the trial?
Bailey: TAURUS (TivozAnib Use Verus Sutent in advanced renal cell carcinoma (RCC): Patient Preference) is a randomized (1:1), double-blind, crossover controlled, multi-center Phase II study comparing tivozanib versus sunitinib in approximately 160 patients with advanced RCC who have received no prior systemic therapy. The primary objective of the study is to compare patient preference for tivozanib or sunitinib.
As we continue to build a robust understanding of tivozanib's safety, tolerability and efficacy profile, we are pleased that the first patient has been initiated in TAURUS and enrollment is currently open at sites throughout the United States and Western Europe.
Q: What's next for tivozanib? Will you be pursuing additional trials in RCC? What about other indications?
Bailey: Yes, we do plan to pursue additional indications. Tivozanib is currently being investigated across a broad range of solid tumors, including metastatic colorectal cancer and metastatic breast cancer.
Q: Can you explain the partnership between AVEO Oncology and Astellas Pharma Inc? Can you tell me more about how the companies' partnership is set up for commercialization of tivozanib?
Bailey: In February 2011, AVEO and Astellas entered into a worldwide agreement to develop and commercialize tivozanib outside of Asia for the treatment of a broad range of cancers. Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America and Astellas will lead commercialization of tivozanib in the European Union.
Q: From an AVEO/Astellas partnership perspective, what are you most excited about in 2013?
Bailey: We look forward to sharing the TIVO-1 overall survival data in 2013 and progressing tivozanib through regulatory milestones in the US and Europe.
We're also looking forward to sharing results from our ongoing tivozanib clinical trials in patients with other cancer types such as metastatic breast and colorectal cancers at future medical congresses.
Q: What's next in the pipeline or what upcoming catalysts should investors be looking out for?
Bailey: We are pleased with what's next in our pipeline. We believe strongly in the broad potential of tivozanib and have an ongoing Phase 2 study in colorectal cancer and anticipate initiating a Phase II breast cancer trial later this year. We also have ficlatuzumab, which targets the HGS ligand, in Phase II development and AV-203, an ERBB3 inhibitor, is currently in Phase I clinical development. We believe these are exciting programs that have the potential to improve the treatment of cancer.