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AVEO And Astellas Announce Positive Findings From TIVO-1 Superiority Study Of Tivozanib In First-Line Advanced RCC

AVEO Oncology (NASDAQ:AVEO) and Astellas Pharma Inc. (TSE:4503) today announced that detailed data from TIVO-1 ( Tivozanib Versus S orafenib in 1 st line Advanced RCC), will be presented on June 2 in an oral session by the principal investigator, Robert J. Motzer, M.D., attending physician, genitourinary oncology service, Memorial Sloan-Kettering Cancer Center, professor of medicine, Weill Medical College, Cornell University, New York, at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO).

TIVO-1 is the first superiority pivotal study in first-line advanced renal cell carcinoma (RCC) in which an investigational agent (tivozanib) has demonstrated statistically significant and clinically meaningful progression-free survival (PFS) superiority versus an approved targeted agent (sorafenib) in advanced RCC.

“TIVO-1 is novel in that this Phase 3 clinical study used an approved targeted comparator drug to evaluate first-line RCC treatment,” said Dr. Motzer. “Patients in the study who had no prior treatment for advanced kidney cancer and who were given tivozanib met the primary PFS endpoint and tolerated the drug well.”

A total of 517 patients were randomized to tivozanib (N=260) or sorafenib (N=257). The performance status and other prognostic indicators of patients enrolled in this study were consistent with other pivotal trials in first-line advanced RCC.

“Despite recent advances in the treatment of kidney cancer, patients are in need of new options which are effective and well-tolerated,” said Daniel George, M.D., director, GU Medical Oncology and director, prostate clinic, Duke University. “The superior PFS and favorable tolerability demonstrated by tivozanib in TIVO-1 represents an important potential step forward for patients in the treatment of kidney cancer.”

Key data from TIVO-1 to be highlighted include (Abstract # 4501):
  • Based on independent radiological reviews, tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall (Intent To Treat) study population (HR=0.797, 95% CI 0.639–0.993; P=0.042). Objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (p=0.014). The efficacy advantage of tivozanib over sorafenib was consistent across subgroups in the study.
  • In patients who were treatment naïve for advanced RCC (70% of total study population), tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib (HR 0.756, 95% CI 0.580–0.985; P=0.037). This is the longest median PFS reported to date in treatment naïve advanced RCC patients in a pivotal study.
    • In the subpopulation of patients who were pretreated with systemic therapy including cytokines (30% of total study population), tivozanib demonstrated an improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib.
  • Study results demonstrated favorable tolerability as evidenced by a distinctively low rate of dose interruptions and reductions. The most common adverse event (all grades/≥grade 3) for tivozanib was hypertension (T: 44%/25% vs S: 34%/17%) and for sorafenib was hand-foot syndrome (T: 13%/2% vs S: 54%/17%). Other adverse events included diarrhea (T: 22%/2% vs S: 32%/6%), fatigue (T: 18%/5% vs S: 16%/4%), and neutropenia (T: 10%/2% vs S: 9%/2%).
    • The rate of dose interruptions due to adverse events was 18% for tivozanib compared to 35% for sorafenib (p<0.001).
    • The rate of dose reductions was 14% for tivozanib compared to 44% for sorafenib (p<0.001).

Overall survival (OS) data are not yet mature. In TIVO-1, 53% of patients randomized to the sorafenib arm of the trial went on to receive subsequent therapy, nearly all of whom received tivozanib after sorafenib. Based on an early, interim analysis, 81% of these patients achieved one year OS. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy, and 77% of these patients achieved one year OS. Mature data are expected to be presented in 2013.

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