Current Report Filing (8-k)
December 18 2018 - 06:03AM
Edgar (US Regulatory)
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): December 17, 2018
PUMA BIOTECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-35703
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77-0683487
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification Number)
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10880 Wilshire Boulevard, Suite 2150
Los Angeles, California 90024
(Address of principal executive offices, including Zip Code)
(424)
248-6500
(Registrants telephone number, including area code)
N/A
(Former name or
former address, if changed since last report)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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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 financing accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On December 17, 2018, Puma Biotechnology, Inc. (the Company) announced top line results from the Phase III NALA trial of the
Companys lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments in the setting of metastatic disease. The Phase III NALA trial is a
randomized controlled trial of neratinib plus capecitabine versus Tykerb
®
(lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled
621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The
co-primary
endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The
study was to be considered positive if either of the
co-primary
endpoints was positive. The Company reached agreement with the U.S. Food and Drug Administration (the FDA) under a Special Protocol
Assessment for the design of the Phase III clinical trial and the European Medicines Agency (the EMA) also provided
follow-on
scientific advice consistent with that of the FDA regarding the
Companys Phase III trial design and endpoints used in the trial.
For the primary analysis of centrally confirmed PFS, treatment
with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. For the primary analyses of OS, neratinib plus capecitabine resulted
in an improvement in OS that did not achieve statistical significance but trended positively in favor of the neratinib plus capecitabine arm of the study (p=0.21). For the secondary endpoint of time to intervention for symptomatic central nervous
system disease, which is also referred to as brain metastases, the results of the trial showed that treatment with neratinib plus capecitabine led to an improvement over the combination of lapatinib plus capecitabine (p=0.043).
The safety profile of neratinib in the Phase III NALA study was consistent with previous clinical trials of neratinib.
The Company expects full results of the trial to be submitted to health authorities around the world, including the FDA and the EMA. The
Company expects results of the trial to be submitted for presentation at a major medical conference in 2019.
Forward-Looking Statements
This Current Report on Form
8-K
contains forward-looking statements regarding the timing of full
results of the NALA trial, as well as the submission of results of the trial to health authorities around the world. All forward-looking statements included in this Current Report on Form
8-K
involve risks and
uncertainties that could cause the Companys actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and
assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, including the risk factors disclosed in the reports filed by the Company with the Securities and Exchange Commission from time to
time, including the Companys Annual Report on Form
10-K
for the year ended December 31, 2017. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
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PUMA BIOTECHNOLOGY, INC.
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Date: December 17, 2018
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By:
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/s/ Alan H. Auerbach
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Alan H. Auerbach
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President and Chief Executive Officer
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