AVEO Oncology Announces Presentation of Final Results of Extension Study 902 and FDA Regulatory Feedback for Advancing Tivozanib in Renal Cell Carcinoma

CAMBRIDGE, Mass.--- AVEO Oncology (AVEO) announced today that final results from the TIVO-1 extension study, known as Study 902, in which patients with advanced renal cell carcinoma (RCC) received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Company’s Phase 3 TIVO-1 first-line RCC study, will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The Company previously reported interim median progression free survival (PFS) results of 8.4 months among the 163 patients enrolled in Study 902. Final results now show a median PFS in this setting of 11.0 months and median overall survival (OS) of 21.6 months, demonstrating the efficacy of tivozanib in a VEGF treatment refractory population.

AVEO also announced today that it has received a written response from the U.S. Food and Drug Administration (FDA) stating that a phase 3 study outlined by the Company, in patients with RCC who have failed at least two prior regimens, including VEGF therapy, “may support AVEO’s proposed indication for tivozanib in the 3^rd line setting.” In response to whether the study, together with the TIVO-1 study, would be sufficient to support licensure of tivozanib as a treatment for advanced RCC, the FDA indicated: “whether the results from this [third line] study can support AVEO’s proposal for tivozanib in the first line setting is a review issue.”

The study design shared with the FDA is a randomized, controlled, multi-center, open-label Phase 3 study of approximately 314 subjects randomized 1:1 to receive either tivozanib or sorafenib. Subjects enrolled in the study may include those who have received prior immunotherapy, including immune checkpoint (PD-1) inhibitors, reflecting a potentially evolving treatment landscape. The primary objective of the study would be PFS. Secondary objectives would include OS and objective response rate (ORR) as well as safety and pharmacokinetic endpoints.

“Based on TIVO-1, where tivozanib led to a longer progression free survival than sorafenib in the first line, combined with the activity tivozanib demonstrated in patients who have progressed on a VEGF therapy, we are optimistic about the probability of a successful clinical outcome in a third line RCC study,” said Michael Bailey, president and chief executive officer of AVEO. “We are also encouraged by the FDA’s willingness to consider whether a refractory study can serve as a confirmatory study for TIVO-1 in first line RCC. Prior to committing to a new study, we will continue to evaluate all options, including partnerships, for the clinical and regulatory advancement for tivozanib in RCC as well as colorectal cancer.”

ASCO Presentation Details

Efficacy results from Study 902 and final results from the TIVO-1 trial will be presented at the 2015 ASCO Annual Meeting being held May 29 – June 2, at McCormick Place in Chicago, Illinois. Details of the presentation are as follows:

Date & Time: Monday June 1, 1:15 PM to 4:45 PM

Poster Title: Tivozanib vs sorafenib targeted therapy for advanced renal cell carcinoma: Final results of a phase III trial (901) and efficacy results of a 2nd line tivozanib extension study (902)

Abstract Number: 4557

Poster Board: #231

Session: Genitourinary (Nonprostate) Cancer

Location: S Hall A

The full abstract can be viewed here.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the Company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the probability of licensure for tivozanib by the FDA as a treatment for advanced RCC; the probability of successful outcomes for a study in third line RCC; and the Company’s plans to continue to assess its options for the regulatory and clinical advancement of tivozanib in renal cell cancer and colorectal cancer. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to successfully implement its restructuring and strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.

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