AVEO Pharmaceuticals’ Oral, Triple VEGF Receptor Inhibitor AV-951 Shows Robust Activity in Patients with Advanced Kidney Cancer

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272-Patient Phase 2 Data Show 91.7 Percent Disease Control Rate and Favorable Tolerability; Interim Results Being Presented at ASCO GU Indicate Highly Differentiated VEGFR Profile


Cambridge, MA - February 25, 2009 - AVEO Pharmaceuticals, Inc., a biopharmaceutical company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced positive interim results from a 272-patient Phase 2 clinical trial of AV-951, a novel, oral, triple VEGF receptor inhibitor, in patients with advanced renal cell carcinoma (RCC). As assessed by independent radiological review, patients with advanced RCC treated with AV-951 experienced a 91.7 percent disease control rate at 16 weeks. The data also demonstrate that AV-951 was well tolerated. These data are to be presented during an oral abstract session at the 2009 Genitourinary Cancers Symposium, a multidisciplinary symposium co-sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiology and Oncology (ASTRO) and the Society of Urologic Oncology (SUO).


“Patients living with kidney cancer are in need of therapies with an improved therapeutic index, that can provide durable responses, as the on and off-target toxicities associated with many of the currently available VEGF receptor inhibitors often lead to treatment interruptions or discontinuation, all of which can negatively impact patients’ overall treatment success,” stated Robert Figlin, M.D., chair, Division of Medical Oncology and Therapeutics Research, and Arthur and Rosalie Kaplan Professor of Medical Oncology at the City of Hope Comprehensive Cancer Center in Duarte, CA. “The disease control rate achieved by kidney cancer patients treated with AV-951 in this trial, combined with its tolerability, builds upon a growing body of evidence demonstrating the potential role for AV-951 as a novel, oral treatment option for patients living with kidney cancer and other difficult-to-treat tumors.”


The Phase 2 placebo-controlled, randomized discontinuation trial assessed the efficacy and safety of once-daily, oral AV-951 in 272 patients with locally advanced or metastatic RCC and no prior VEGF-targeted therapy. Key results include:

  • Disease control rate at 16 weeks was 88.8 percent (89.4% in clear cell RCC) by investigator assessment and 91.7 percent (91.9% in clear cell RCC) by independent radiology assessment.
  • Objective response rate at 16 weeks was 26.4 percent (29.6% in clear cell RCC) by investigator assessment and 20.1 percent (20.6% in clear cell RCC) by independent radiology assessment using standard RECIST criteria.
  • Among patients with ≥25% tumor regression who continued uninterrupted treatment on AV-951, the median progression free survival (PFS) has not been reached during a follow-up duration of 12.6 months.

The most common treatment-related adverse events seen in this interim analysis were hypertension and dysphonia (hoarseness of voice), both of which were readily manageable and are recognized as “on-target” effects expected of a highly potent and selective VEGF receptor inhibitor. The safety profile of AV-951 observed in the trial was notable for the minimal off-target toxicities such as mucositis/stomatitis, fatigue, neutropenia and hand-foot syndrome.


“The activity of AV-951 in advanced renal cancer is indicative of its potential single-agent utility in the treatment of these difficult-to-treat tumors, while the favorable safety profile continues to reaffirm the potential for AV-951 combinability with other important cancer treatment regimens,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “These interim Phase 2 results clearly underscore the value of this novel agent, and we look forward to presenting the complete results from this trial, including PFS data, at an upcoming medical meeting later this year. With our recently initiated combination and single agent clinical trials in kidney, colorectal and breast cancers, as well as our plans to initiate a pivotal Phase 3 trial in advanced renal cancer later this year, AV-951 is poised for success among the anti-angiogenic agents currently available and in development.”


AVEO has also initiated ongoing Phase 1b clinical trials of AV-951: in combination with temsirolimus, an approved mTOR inhibitor, in patients with mRCC; in combination with the FOLFOX6 chemotherapy regimen in patients with advanced colorectal cancer and other gastrointestinal cancers; and, in combination with paclitaxel in patients with metastatic breast cancer.

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