AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD.
On November3, 2017, results of AVEO’s ongoing phase 1 portion of the TiNivo study, a phase 1/2 multicenter trial of tivozanib (FOTIVDA®) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO®), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma (RCC) are being presented at the 16th International Kidney Cancer Symposium in Miami, Florida, in an oral presentation titled “TiNivo: A Phase Ib Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma” by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study.
The phase 1 portion of the trial enrolled six patients, three with previously untreated metastatic RCC and three who had received first-line treatment. RCC tumor histology included five clear cell (one with sarcomatoid features) and one papillary. Tivozanib was administered to patients in two escalating dose cohorts (1.0 mg/QD and 1.5 mg/QD) in combination with nivolumab at a constant 240 mg every 2 weeks. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Unconfirmed best response to date includes a 67% (4/6) partial response (PR) rate and a 50% disease control rate (PR + stable disease). Enrollment of approximately 20 patients in the phase 2 portion of the trial is ongoing.
AVEO is encouraged by the promising preliminary tolerability and activity results from the TiNivo trial, and believes that they begin to underscore the unique potential of tivozanib-immunotherapy combinations. The Company expects to present the results of the phase 2 portion of the TiNivo trial in the first half of 2018, and anticipates initiating additional combination studies in the next year.
The information in this Item 7.01 shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
About AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO)
AVEO Pharmaceuticals, Inc. is a biopharmaceutical company. The Company’s platform delivers insights into cancer and related disease. The Company’s product candidates include Tivozanib, Ficlatuzumab, AV-203 and AV-380. Tivozanib is a selective long half-life vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) that inhibits over three VEGF receptors. Tivozanib is designed to optimize VEGF blockade while minimizing off-target toxicities. Ficlatuzumab is a Hepatocyte Growth Factor (HGF) inhibitory antibody. AV-203 is an anti-ErbB3 monoclonal antibody with ErbB3 affinity. Its preclinical studies suggest that neuregulin1 (NRG1) levels predict AV-203 antitumor activity in preclinical models. AV-380 is a humanized Immunoglobulin G 1 (IgG1) inhibitory monoclonal antibody. AV-380 targets growth differentiating factor 15 (GDF15).
