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AVEO And Astellas Announce New Data Presented At ESMO 2012 Congress Demonstrating The Safety And Tolerability Profile Of Tivozanib In Patients With Advanced Kidney Cancer

Investigators evaluated drug-related AEs versus sorafenib with the goal of better understanding the tivozanib safety profile. The results of the safety analysis showed:

  • Investigator-reported adverse events for tivozanib showed lower rates of dose reductions, interruptions, and discontinuations compared to sorafenib: dose reductions (11.6% vs. 42.8%, p<0.001), interruptions (17.8% vs. 35.4%, p<0.001), and discontinuations (4.2% vs. 5.4%) 1
  • Drug-related AEs occurred in fewer patients on tivozanib than patients on sorafenib (67.6% vs. 83.3%) 1
  • Fewer patients in the tivozanib group had ≥Grade 3 drug-related AEs than patients in the sorafenib group (36.3% vs. 51.0%, respectively). 1 ≥Grade 3 hypertension, an established on-target effect of angiogenesis inhibitors, was more common in the tivozanib group (23.6% vs. 15.2%), and ≥Grade 3 hand-foot syndrome (1.9% vs. 16.7%), diarrhea (1.9% vs. 5.8%) and lipase elevation (0.8% vs. 5.8%) were more common in the sorafenib group. 1

“Our tivozanib development program in RCC is comprehensive and ongoing. With positive safety and efficacy data from TIVO-1 in-hand, we continue to explore the role of biomarkers and patient preference with the ultimate goal of helping clinicians optimize RCC treatment,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Additional analyses from our ongoing biomarker program will be presented at future congresses and our TAURUS patient preference study vs. Sutent® (sunitinib) is now underway.”

In addition to detailed safety results, pharmacokinetic/pharmacodynamic data from TIVO-1 were also presented. 3

Title: Tivozanib Pharmacokinetic/Pharmacodynamic Analysis of Blood Pressure and Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2) in Patients with Advanced Renal Cell CarcinomaDate/Poster/Location: Oct. 1, 1:00-2:00pm CET / 7:00-8:00am ET; Poster #796PD; Hall F2

Analyses were conducted using pooled data from patients in AVEO’s randomized placebo-controlled Phase 2 study of tivozanib in RCC and from the TIVO-1 study to explore the relationship between tivozanib exposure, blood pressure and sVEGFR2. 3

Patients in the analysis showed a median increase in diastolic blood pressure of 5mm Hg compared with baseline, and also experienced a decrease in sVEGFR2 corresponding to tivozanib exposure. 3 Hypertension and sVEGFR are known to be on-target biomarkers of activity and clinical outcome. 4,5,6

“One of our goals in becoming a global Category Leader in oncology is to develop precision medicines that revolutionize the methods used to treat patients with cancer,” said Stephen Eck, M.D., Ph.D., Vice President of Medical Oncology, Astellas Pharma Global Development. “We believe the data showing the combination of tivozanib’s statistically significant PFS and its tolerability profile represents a potentially important advancement in the treatment of this disease.”

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