• Net loss for the second quarter of 2012 was $29.5 million, or basic and diluted net loss per share of $0.68, compared with net loss of $5.7 million, or basic and diluted net loss per share of $0.16, for the second quarter of 2011.
• AVEO ended the second quarter of 2012 with cash, cash equivalents and marketable securities of $215.9 million.
AVEO is maintaining its financial guidance and continues to expect year-end 2012 cash, cash equivalents and marketable securities of at least $120 million, with R&D spending, net of cost sharing with Astellas, of approximately $130 million. AVEO anticipates that this capital is sufficient to fund its operations into the second half of 2013 based on its current operating plans.Recent Developments
- Recap of TIVO-1: AVEO and Astellas reported detailed data from TIVO-1 ( Tivozanib Versus S orafenib in 1 st line RCC), a global, randomized, Phase 3, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma (RCC), which were presented at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, and tivozanib demonstrated favorable tolerability as evidenced by a significantly lower rate of dose interruptions and reductions as compared to sorafenib. Key data reported from TIVO-1 based on independent radiological reviews include:
- 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 from TIVO-1 are not yet mature and medians have not been reached. Estimated OS rate at one year was 81% among patients randomized to the sorafenib arm and 77% among patients randomized to tivozanib. However, as reported at ASCO, 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. In comparison, only 17% of patients randomized to tivozanib went on to receive a subsequent therapy.
- Regulatory Update: The FDA has expressed concern regarding the OS trend in the TIVO-1 trial and has said that it will review these findings at the time of the NDA filing as well as during the review of the NDA. AVEO is conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy; analyses that the company believes will directly address this issue. AVEO is continuing to work toward submitting the NDA by end of the third quarter; however, there is a chance that the additional OS analyses may cause the submission to move into the fourth quarter.
- TAURUS patient preference clinical study: In June 2012, AVEO and Astellas announced plans to initiate a new clinical study, TAURUS ( Tivoz Anib Use ve Rs Us Sutent in advanced RCC: Patient Preference), to establish additional data regarding tivozanib when used as first-line therapy in patients with advanced RCC. The TAURUS study will enroll patients at sites throughout the United States and Western Europe, and the primary objective of the study is designed as a superiority comparison of tivozanib versus sunitinib with respect to patient preference. Secondary objectives are to evaluate the incidence of treatment emergent Grade 3/4 adverse events and serious adverse events; frequency of dose modifications; and quality of life in patients treated with tivozanib versus sunitinib.
- Preliminary results from ficlatuzumab exploratory Phase 2 study: The open-label, randomized exploratory Phase 2 study was designed to compare the combination of ficlatuzumab and gefitinib versus gefitinib monotherapy, in Asian subjects with previously untreated advanced non-small cell lung cancer, a population with a high occurrence of EGFR sensitizing mutations. The ficlatuzumab/gefitinib combination was well-tolerated and the trend of clinical activity favored this arm; however, study results in the overall population did not reach statistical significance. Detailed findings from this study have been accepted for a presentation at ESMO in September. AVEO expects to provide additional information regarding its plans in support of further development of ficlatuzumab at that time.
- Phase 1 study of AV-203: AVEO announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, and was developed through AVEO’s Human Response Platform™. This advancement marked the third AVEO product candidate to enter clinical development.
- Canaccord Genuity 32 nd Annual Growth Conference, August 14-16, 2012 in Boston.
- Morgan Stanley Global Healthcare Conference, September 10-12, 2012 in New York City.
- European Society for Medical Oncology (ESMO) 2012 Congress, September 28-October 2, 2012 in Vienna.
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