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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:10pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>WASHINGTON, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B><FONT
STYLE="white-space:nowrap">FORM&nbsp;8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): February&nbsp;5, 2019 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>AVEO Pharmaceuticals, Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact Name of Registrant as Specified in Charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-34655</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">04-3581650</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or Other Jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of Incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>One Broadway, 14th Floor</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>Cambridge, Massachusetts</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>02142</B></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>(Address of Principal Executive Offices)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(Zip Code)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area
<FONT STYLE="white-space:nowrap">code:&nbsp;(617)&nbsp;588-1960</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below
if the <FONT STYLE="white-space:nowrap">Form&nbsp;8-K&nbsp;filing</FONT> is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14a-12&nbsp;under</FONT> the
Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> and the exhibit attached hereto contain forward-looking statements of AVEO
Pharmaceuticals, Inc. (&#147;AVEO&#148;) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> and the
attached exhibit are forward-looking statements. The words &#147;anticipate,&#148; &#147;believe,&#148; &#147;estimate,&#148; &#147;expect,&#148; &#147;intend,&#148; &#147;may,&#148; &#147;plan,&#148; &#147;predict,&#148; &#147;project,&#148;
&#147;target,&#148; &#147;potential,&#148; &#147;will,&#148; &#147;would,&#148; &#147;could,&#148; &#147;should,&#148; &#147;continue,&#148; &#147;contemplate,&#148; &#147;seek,&#148; &#147;look forward,&#148; &#147;advance,&#148; &#147;goal,&#148;
&#147;strategy,&#148; 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: AVEO&#146;s goals and business strategy, prospects, plans and objectives; AVEO&#146;s plans regarding submitting a new drug application (&#147;NDA&#148;) to the U.S. Food and Drug Administration
(&#147;FDA&#148;) for tivozanib; the timing, design and results of preclinical and clinical trials, including AVEO&#146;s plans to conduct, and expectations regarding the timing and potential results of, interim and final overall survival analyses
for the Phase 3 <FONT STYLE="white-space:nowrap">TIVO-3</FONT> study of tivozanib in RCC; AVEO&#146;s plans regarding the potential efficacy, safety and tolerability profile of tivozanib, including with respect to overall survival; AVEO&#146;s
expectation regarding submitting updated informed consent forms (&#147;ICFs&#148;) to the FDA and using them obtain consent from patients in ongoing and future trials; and the timing and outcome of meetings with and applications to regulatory
authorities by AVEO. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking
statements AVEO makes due to a number of important factors, including substantial risks and uncertainties relating to: AVEO&#146;s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such
as the FDA the safety, efficacy and clinically meaningful benefit of AVEO&#146;s product candidates, including as it relates to the <FONT STYLE="white-space:nowrap">TIVO-3</FONT> trial and tivozanib; AVEO&#146;s ability to successfully file an NDA
for tivozanib on the timeline it anticipates, or at all; AVEO&#146;s and its collaborators&#146; ability to successfully enroll and complete clinical trials; and AVEO&#146;s ability to enter into and maintain its third party collaboration and
license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to
the timing and costs of seeking and obtaining regulatory approval; AVEO&#146;s ability to maintain compliance with regulatory requirements applicable to its product candidates; AVEO&#146;s ability to obtain and maintain adequate protection for
intellectual property rights relating to its product candidates; AVEO&#146;s ability to successfully implement its strategic plans; AVEO&#146;s ability to raise the substantial additional funds required to achieve its goals, including those goals
pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the sections titled &#147;Risk Factors&#148; and
&#147;Management&#146;s Discussion and Analysis of Financial Condition and Results of Operations&#151;Liquidity and Capital Resources&#148; included in AVEO&#146;s quarterly and annual reports on file with the SEC and in other filings that AVEO may
make with the Securities and Exchange Commission in the future.&nbsp;All forward-looking statements contained in this Current Report on <FONT STYLE="white-space:nowrap">Form&nbsp;8-K</FONT> speak only as of the date of this Current Report, and AVEO
undertakes no obligation, and specifically disclaims any obligation, to update any of these statements, except as required by law. You should, therefore, not rely on these forward-looking statements as representing AVEO&#146;s views as of any date
subsequent to the date of this Current Report. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;8.01. Other Events </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As disclosed on January&nbsp;31, 2019, and following a meeting with the U.S. Food and Drug Administration (&#147;FDA&#148; or &#147;Agency&#148;), AVEO
Oncology (&#147;Company&#148; or &#147;AVEO&#148;) announced its decision to accept the FDA&#146;s recommendation not to submit a New Drug Application (&#147;NDA&#148;) for tivozanib with preliminary overall survival (&#147;OS&#148;) results from
the Company&#146;s Phase 3 <FONT STYLE="white-space:nowrap">TIVO-3</FONT> trial. The FDA had indicated that these preliminary OS results did not allay their concerns about the potential detriment in OS outlined in the complete response letter dated
June&nbsp;6, 2013. The Company also announced its plan to designate an August 2019 OS analysis as interim, rather than final, in order to allow time for the OS data to mature. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On February&nbsp;5, 2019, AVEO received final minutes from that meeting with the FDA. The minutes reflect both a summary of the meeting and decisions or
recommendations made by the Agency after the meeting. The minutes reflect the Company&#146;s agreement not to submit an NDA at this time. In the minutes, the FDA notes that the Company may decide to submit a formal interim analysis with an
appropriate statistical error allocation at a later date; requests that the Company provide any OS analysis performed to the FDA; and recommends that the Company not conduct any exploratory OS updates. The minutes also reflect the FDA&#146;s request
that the Company submit any revision to the <FONT STYLE="white-space:nowrap">TIVO-3</FONT> statistical analysis protocol to the Agency for review. Finally, the FDA asked the Company to submit updated informed consent forms (&#147;ICFs&#148;) to the
Agency for review that will be used to obtain consent from patients in ongoing and future trials. The revised ICFs will include information about all of the tivozanib clinical trial OS outcomes to date. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:2%; text-indent:-2%; font-size:10pt; font-family:Times New Roman">Date: February&nbsp;6, 2019 </P><DIV ALIGN="right">
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<TD VALIGN="top" COLSPAN="3"><B>AVEO Pharmaceuticals, Inc.</B></TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Michael Bailey</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Michael Bailey</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">President and Chief Executive Officer</TD></TR>
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8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 5, 2019
AVEO Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
001-34655
04-3581650
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
One Broadway, 14th Floor
Cambridge, Massachusetts
02142
(Address of Principal Executive Offices)
(Zip Code)
Registrant's telephone number, including area
code: (617) 588-1960
Check the appropriate box below
if the
Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to
Rule 14a-12 under
the
Exchange Act (17
CFR 240.14a-12)
☐
Pre-commencement communications
pursuant to
Rule 14d-2(b) under
the Exchange Act (17
CFR 240.14d-2(b))
☐
Pre-commencement communications
pursuant to
Rule 13e-4(c) under
the Exchange Act (17
CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company  ☐
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act.  ☐
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form
8-K
and the exhibit attached hereto contain forward-looking statements of AVEO
Pharmaceuticals, Inc. ("AVEO") that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Current Report on Form
8-K
and the
attached exhibit are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue," "contemplate," "seek," "look forward," "advance," "goal,"
"strategy," 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: AVEO's goals and business strategy, prospects, plans and objectives; AVEO's plans regarding submitting a new drug application ("NDA") to the U.S. Food and Drug Administration
("FDA") for tivozanib; the timing, design and results of preclinical and clinical trials, including AVEO's plans to conduct, and expectations regarding the timing and potential results of, interim and final overall survival analyses
for the Phase 3
TIVO-3
study of tivozanib in RCC; AVEO's plans regarding the potential efficacy, safety and tolerability profile of tivozanib, including with respect to overall survival; AVEO's
expectation regarding submitting updated informed consent forms ("ICFs") to the FDA and using them obtain consent from patients in ongoing and future trials; and the timing and outcome of meetings with and applications to regulatory
authorities by AVEO.
Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking
statements AVEO makes due to a number of important factors, including substantial risks and uncertainties relating to: AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such
as the FDA the safety, efficacy and clinically meaningful benefit of AVEO's product candidates, including as it relates to the
TIVO-3
trial and tivozanib; AVEO's ability to successfully file an NDA
for tivozanib on the timeline it anticipates, or at all; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; and AVEO's ability to enter into and maintain its third party collaboration and
license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements. AVEO faces other risks relating to its business as well, including risks relating to
the timing and costs of seeking and obtaining regulatory approval; AVEO's ability to maintain compliance with 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; AVEO's ability to successfully implement its strategic plans; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals
pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the sections titled "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO's quarterly and annual reports on file with the SEC and in other filings that AVEO may
make with the Securities and Exchange Commission in the future. All forward-looking statements contained in this Current Report on
Form 8-K
speak only as of the date of this Current Report, and AVEO
undertakes no obligation, and specifically disclaims any obligation, to update any of these statements, except as required by law. 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 Current Report.
Item 8.01. Other Events
As disclosed on January 31, 2019, and following a meeting with the U.S. Food and Drug Administration ("FDA" or "Agency"), AVEO
Oncology ("Company" or "AVEO") announced its decision to accept the FDA's recommendation not to submit a New Drug Application ("NDA") for tivozanib with preliminary overall survival ("OS") results from
the Company's Phase 3
TIVO-3
trial. The FDA had indicated that these preliminary OS results did not allay their concerns about the potential detriment in OS outlined in the complete response letter dated
June 6, 2013. The Company also announced its plan to designate an August 2019 OS analysis as interim, rather than final, in order to allow time for the OS data to mature.
On February 5, 2019, AVEO received final minutes from that meeting with the FDA. The minutes reflect both a summary of the meeting and decisions or
recommendations made by the Agency after the meeting. The minutes reflect the Company's agreement not to submit an NDA at this time. In the minutes, the FDA notes that the Company may decide to submit a formal interim analysis with an
appropriate statistical error allocation at a later date; requests that the Company provide any OS analysis performed to the FDA; and recommends that the Company not conduct any exploratory OS updates. The minutes also reflect the FDA's request
that the Company submit any revision to the
TIVO-3
statistical analysis protocol to the Agency for review. Finally, the FDA asked the Company to submit updated informed consent forms ("ICFs") to the
Agency for review that will be used to obtain consent from patients in ongoing and future trials. The revised ICFs will include information about all of the tivozanib clinical trial OS outcomes to date.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
Date: February 6, 2019
AVEO Pharmaceuticals, Inc.
By:
/s/ Michael Bailey
Michael Bailey
President and Chief Executive Officer