 AVEO 4Q12 Results Conference Call and Tivozanib Update February 13, 2013 1 Exhibit 99.1 |
 Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” 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 potential therapeutic advantages and benefits of tivozanib; the timing and results of our ongoing clinical trials; and the potential of tivozanib to obtain regulatory approval and enter the advanced renal cell cancer market. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make due to a number of important factors, including risks and uncertainties relating to: our ability to successfully develop, test and gain regulatory approval of our product candidates, including regulatory approval of tivozanib to treat advanced renal cell cancer; our ability to obtain, maintain and enforce intellectual property rights; competition; our dependence on our alliance partners and other third parties; our ability to obtain necessary financing; adverse economic conditions; and those risk factors discussed in the “Risk Factors” and elsewhere in our Current Report on Form 8-K that was filed with the Securities and Exchange Commission (“SEC”) on January 16, 2013, and other periodic filings we make with the SEC. All forward-looking statements contained in this presentation speak only as of the date of this presentation, and we undertake no obligation to update any of these statements, except as required by law. 2 |
 Tivozanib Update: Bill Slichenmyer, MD Chief Medical Officer February 13, 2013 3 |
 TIVO-1: Phase 3 Superiority Study of Tivozanib vs. Sorafenib as First-line Targeted Therapy for Advanced RCC 4 |
 Overall TIVO-1 Primary Endpoint: PFS by Independent Review Treatment Naïve for Metastatic RCC n Median PFS (95% CI) HR P Value Tivozanib 260 11.9 mos (9.3-14.7) 0.797 0.042 Sorafenib 257 9.1 mos (7.3-9.5) n Median PFS (95% CI) HR P Value Tivozanib 181 12.7 mos (9.1-15.0) 0.756 0.037 Sorafenib 181 9.1 mos (7.3-10.8) CI=confidence interval; HR= hazard ratio Motzer, et al., ASCO 2012 5 0 5 10 15 20 0 20 40 60 80 100 0 20 40 60 80 100 0 5 10 15 20 Time (months) Time (months) |
 February 12, 2013 6 • >1,000 subjects treated with tivozanib • Lower rates than sorafenib for common adverse events and dose modifications • Rate of fatal AEs consistent with reports from past pivotal RCC trials Dose Adjustments Motzer, et al., ASCO 2012 * Due to AE’s **Due to treatment-related AE’s Tivozanib Safety Profile 44 25 34 17 0 5 10 15 20 25 30 35 40 45 50 All Grades Grades 3/4 Treatment Emergent Hypertension tivozanib sorafenib 2 2 5 17 6 4 0 2 4 6 8 10 12 14 16 18 20 Hand-Foot Syndrome Diarrhea Fatigue Other Common Treatment Emergent AEs (Grades 3/4 ) tivozanib sorafenib 12 18 4 43 35 5 0 5 10 15 20 25 30 35 40 45 50 tivozanib sorafenib |
 Overall Survival • Overall Survival (OS) is secondary endpoint in TIVO-1 • Results from interim analysis were disclosed in May 2012 7 |
 2013 ASCO GU Symposia: TIVO-1 Data Presentations 8 |
 Five Posters to be Presented at ASCO GU 1. Overall Survival in TIVO-1: Motzer et al. Title: Overall Survival Results from a Phase 3 Study of Tivozanib Hydrochloride vs Sorafenib in Patients with Renal Cell Carcinoma Abstract : 350 2. Tivozanib in 2 Line Following Sorafenib: Motzer et al. Title: Efficacy and Safety Data from Patients with Advanced Renal Cell Cancer Treated with Tivozanib Hydrochloride After Progression on Sorafenib Abstract : 364 3. Subgroup Analyses from TIVO-1: Hutson et al. Title: Subgroup Analyses of a Phase 3 Trial Comparing Tivozanib Hydrochloride vs Sorafenib as Initial Targeted Therapy for Patients with Metastatic Renal Cell Carcinoma Abstract : 354 4. Quality of Life Results from TIVO-1: Cella et al. Title: Treatment Benefit of Tivozanib Hydrochloride versus Sorafenib on Health-Related Quality of Life among Patients with Advanced/Metastatic Renal Cell Carcinoma Abstract : 355 5. Hypoxia Signature and Tivozanib Activity: Robinson et al. Title: Relationship of Hypoxia Signature with Variant Subgroup of Clear Cell Renal Cell Carcinoma (ccRCC) and its Association with Clinical Activity on Tivozanib Hydrochloride Abstract : 361 9 nd # # # # # |
 Overall Survival in TIVO-1: Motzer et al. Abstract #350 10 |
 11 Protocol-Specified, Final OS Analysis Final OS analysis conducted, per protocol, at two years following last patient enrolled (August 2012) 0.4% 8.3% 15% 21% 28% 37% 43% 48% 53% 57% 59% 61% 67% 58% 100% % of control arm pts crossed over to tivozanib Time (months) |
 Use of Next-Line Treatments 12 *Other includes radiotherapy, cytokine or other therapy |
 OS in Patients from North America/Western Europe 13 |
 Use of Next-line Therapies in North America/Western Europe 14 *Other includes radiotherapy, cytokine or other therapy |
 Next-line Therapy and Overall Survival Motzer, et al. Abstract #350, continued 15 |
 Comparisons of Subgroups who Received Comparable Next-line Therapy • Multiple factors limit validity of comparisons in the following Kaplan-Meier displays, including – Exploratory analyses conducted post-hoc – Patients are classified in these subgroups based on decisions about next-line therapy, which are potentially biased – Small subsets leading to imprecise survival estimates 16 |
 Subset of Patients Who Have Received No 2 -Line Therapy: “1 vs 1” HR=0.917 P 17 “1 vs 1 treatment” =0.662 nd |
 OS Analysis of “2 vs 2” Lines of Treatment: Next-line VEGF Treatment Only 18 HR=1.37 % of patients with next-line anti-VEGF therapy 70% anti-VEGF 10% anti-VEGF P =0.382 |
 OS Analysis of “2 vs 2” Lines of Treatment: Any Anticancer Treatment 19 HR=1.58 P =0.027 % of patients with next-line other/VEGF/mTOR therapy 18% other 10% VEGF 8% mTOR 3% other 70% VEGF 2% mTOR |
 Tivozanib in 2 Line Following Sorafenib: Motzer et al. Abstract #364 20 nd |
 Change From Baseline for Target Lesions (Investigator Assessment) 21 141 patients had measurable disease at baseline and at least one subsequent scan *9 additional unconfirmed responses ORR (confirmed + unconfirmed) = 19% Overall Response Rate (confirmed)* = 13% |
 PFS and OS for Patients Receiving Tivozanib after Progression on Sorafenib Median PFS = 8.4 months 95% CI: 5.5-12.4 Median OS = 19.6 months 95% CI: 14.1-NA tivozanib % PFS % OS 22 tivozanib |
 Subgroup Analyses from TIVO-1: Hutson et al. Abstract #354 23 |
 Forest Plot of PFS Hazard Ratios by Independent Radiological Review Assessment 24 a MSKCC and Heng “poor” prognostic subgroups too small to estimate HR; therefore exclude b By independent radiological review assessment |
 PFS by Prior Treatment History Time (months) Time (months) No prior systemic therapy for metastatic disease One prior systemic therapy for metastatic disease 25 |
 PFS in North America/Western Europe and Central Europe Time (months) Time (months) Central / Eastern Europe North America / Western Europe 26 |
 27 ECOG Score 0 ECOG Score 1 Time (months) Time (months) 0 20 40 60 80 100 0 20 40 60 80 100 0 5 10 15 20 0 5 10 15 20 Tivozanib arm 116 14.8 (11.3–NR) N Median PFS (95% CI) HR P value 0.617 0.004 Sorafenib arm 139 9.1 (7.5–11) Tivozanib arm 144 9.1 (7.5–12.9) N Median PFS (95% CI) HR P value 0.920 0.588 Sorafenib arm 118 9 (7.2–10.9) PFS by ECOG Performance Status Score |
 PFS by MSKCC Favorable or Intermediate Score Time (months) Time (months) MSKCC intermediate MSKCC favorable MSKCC “poor” prognostic subgroup too small to estimate HR, therefore excluded 28 |
 On Study BP and PFS 29 On-study BP, mm Hg Tivozanib Sorafenib mPFS (95% CI) n mPFS (95% CI) n P value SBP 140 9.0 (7.2–11.3) 144 5.8 (5.5–9.0) 140 0.142 SBP >140 16.7 (12.9–18.3) 115 11.1 (9.2–14.7) 116 0.076 DBP 90 9.1 (7.5–12.7) 158 7.3 (5.7–9.1) 169 0.156 DBP >90 18.3 (12.9–NA) 101 11.0 (9.3–16.4) 87 0.154 |
 Quality of Life Results from TIVO-1: Cella et al. Abstract #355 30 |
 More Patients Experience Health-related QOL Improvement on Tivozanib than on Sorafenib Across Most QOL Domains 31 • Numeric differences favoring tivozanib were observed regarding improvement rates across all subgroups and HRQoL scores, except Social Well Being (SWB). • Statistically significant difference in rates of improvement was observed in the Physical Well Being (PWB) score for the total cohort with a consistent trend across several subgroups. |
 Conclusions • Primary endpoint (PFS superiority) met in TIVO-1, and favorable safety profile demonstrated • Final overall survival (secondary endpoint) results reported – OS medians OS are 28.8 and 29.3 months in the tivozanib and comparator arms, respectively; Hazard Ratio is 1.25 with p-value of 0.105 – Numerically longer OS observed in comparator arm associated with higher rate of use of active next-line therapy, predominantly tivozanib as crossover therapy after progression on sorafenib • In patients who progressed on sorafenib and then received tivozanib, median PFS of 8.4 months observed – Tumor regression observed in 74% leading to ORR of 13% • PFS benefit for tivozanib over sorafenib consistent across numerous subsets • More patients experienced Health-Related QOL improvement on tivozanib than on sorafenib across most QOL domains 32 |
 AVEO 4Q12 Results Conference Call and Tivozanib Update February 13, 2013 33 |