On March 22, 2017 AVEO Oncology (NASDAQ:AVEO) reported financial results for the full year ended December 31, 2016 and provided a business update (Press release, AVEO, MAR 22, 2017, View Source [SID1234518237]). Schedule your 30 min Free 1stOncology Demo! "TIVO-3, our lead clinical program designed to serve as the basis for a potential U.S. registration for tivozanib as a first- and third-line treatment for renal cell cancer, continues to enroll ahead of schedule and has now completed its first safety review," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to the study’s pre-planned interim futility analysis midyear 2017 and, potentially, to top line results in the first quarter of 2018 and to initial data from our Phase 1 TiNivo study of tivozanib in combination with Opdivo in the first half of 2017. We also continue to support our partner EUSA Pharma in its efforts to complete the European Marketing Authorization Application review for tivozanib as a first-line treatment for renal cell carcinoma. There remains a significant unmet need for better tolerated therapies in this disease, particularly those that enable combination treatment, and we look forward to receiving tivozanib data and to potential regulatory milestones in the coming quarters."
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Mr. Bailey continued: "We also look forward to several milestones with the balance of our pipeline, including the presentation of data from two investigator sponsored studies of ficlatuzumab, a potential partnership for AV-353, and progress toward the clinic for AV-380 and AV-203."
Recent Updates
TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first-line treatment for RCC.
First Patient Dosed in Phase 1/2 TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in Advanced RCC. AVEO announced today that the first patient has been treated in the Company’s Phase 1/2 TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced RCC. The study, which is led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1, which the Company expects to complete in the first half of 2017, will primarily evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib. If the Company receives favorable results, it expects to follow immediately with an expansion Phase 2 at the established combination dose.
Ongoing Review of the Marketing Authorization Application (MAA) in Europe for Approval of Tivozanib as a First-Line RCC Treatment Option. In February 2017, AVEO announced that its European licensee for tivozanib, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has received the Day 180 List of Outstanding Issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The Day 180 LOI signifies that the MAA is not approvable at the present time and outlines outstanding deficiencies, which are then required to be satisfactorily addressed in an oral explanation and/or in writing prior to a final application decision. EUSA has informed AVEO that it expects to submit written responses to the Day 180 LOI in April 2017, and the EMA has tentatively scheduled EUSA to provide an oral explanation to the CHMP in May 2017.
Submitted for Presentation Results from Phase 1 Studies of Ficlatuzumab in Combination with Cetuximab in Head and Neck Squamous Cell Cancer (HNSCC) and Cytarabine in Acute Myeloid Leukemia (AML). The Company announced today that results from two investigator sponsored Phase 1 studies of ficlatuzumab were submitted for presentation at an upcoming major medical meeting. The first study is designed to explore cetuximab in combination with ascending doses of ficlatuzumab in patients with cetuximab-refractory HNSCC patients. The second study is designed to explore cytarabine in combination with ascending doses of ficlatuzumab in relapsed/refractory AML. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab.
Full Year 2016 Financial Highlights
AVEO ended 2016 with $23.3 million in cash, cash equivalents and marketable securities as compared with $34.1 million at December 31, 2015.
Total collaboration revenue for 2016 was approximately $2.5 million compared with $19.0 million for 2015.
Research and development expense for 2016 was $23.7 million compared with $12.9 million for 2015.
General and administrative expenses for 2016 were $8.2 million compared with $14.2 million for 2015.
Net loss for 2016 was $26.9 million, or a loss of $0.39 per basic and diluted share, compared with net loss of $15.0 million for 2015, or a loss of $0.27 per basic and diluted share.
Financial Guidance
We believe that our $23.3 million in existing cash, cash equivalents and marketable securities as of December 31, 2016 could allow us to fund our planned operations into the fourth quarter of 2017; however, additional funds will be needed to extend these operations into 2018 and maintain compliance with our $10.0 million financial covenant under our loan agreement with Hercules.