PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Files An 8-K Other Events
Item8.01
| Other Events. |
On March1, 2017, Puma Biotechnology, Inc. (the Company) announced
that based on its recent meeting with the Rapporteur,
Co-Rapporteur and review team members, as well as the European
Medicines Agency (EMA), the Company plans to modify the summary
of product characteristics (SmPC), sometimes referred to as the
European product label, in its Marketing Authorisation
Application (MAA) to restrict the intended population to patients
initiating neratinib treatment within one year after completion
of adjuvant trastuzumab therapy. The proposed SmPC will continue
to include both hormone receptor positive and hormone receptor
negative patients.
The Company recently conducted a meeting with the Rapporteur,
Co-rapporteur and members of the review team as well as EMA to
discuss the responses to the 120-day list of questions received
in connection with the Companys MAA for neratinib that was
submitted in the summer of 2016. The initially proposed
indication was for the extended adjuvant treatment of adult
patients with early-stage HER2-overexpressed/amplified breast
cancer who have received prior adjuvant trastuzumab based
therapy. During this meeting it was discussed that neratinib
would likely be sequenced immediately after adjuvant trastuzumab
and more benefit was observed in the subgroup of patients who
received neratinib within 1 year from prior trastuzumab
completion when compared with those patients receiving neratinib
after 1 year from the completion of prior trastuzumab
treatment.In addition, data from the pivotal adjuvant trastuzumab
trials suggest that patients are at higher risk of recurrence
closer to completion of adjuvant trastuzumab, and the risk of
recurrence may decrease over time.
Based on this meeting, the Company will be revising the proposed
SmPC in its MAA for neratinib to restrict the intended population
to those patients initiating neratinib treatment within one year
after completion of adjuvant trastuzumab therapy. The Committee
for Medicinal Products for Human Use (CHMP) is continuing to
review the Companys MAA and has not yet made a final decision to
recommend approval of the drug for the updated or any other
indication and there is no guarantee when, if ever, the MAA will
be approved. The tables below, based on the interim 5 year
analysis announced in July 2016, show results for the invasive
disease free survival (DFS) of the initially proposed intent to
treat population and the intent to treat population (both hormone
receptor positive and hormone receptor negative) in the subgroup
of patients who initiated neratinib treatment within one year
after completion of adjuvant trastuzumab therapy.
DFS for Initially Proposed Intent to Treat (ITT)
Population
|
2-Year DFS |
3-Year DFS |
4-Year DFS |
5-Year Interim DFS |
|||||
|
Neratinib |
94.3% | 92.5% | 91.4% | 90.4% | ||||
|
Placebo |
91.9% | 90.3% | 89.2% | 87.9% | ||||
|
Absolute invasive DFS Difference |
2.4% | 2.2% | 2.2% | 2.5% |
DFS for Intent to Treat (ITT) Population in Patients
Initiating Neratinib Treatment Less Than One Year After
the Completion of Adjuvant Trastuzumab
|
2-Year DFS |
3-Year DFS |
4-Year DFS |
5-Year Interim DFS |
|||||
|
Neratinib |
93.8% | 92.0% | 90.8% | 89.9% | ||||
|
Placebo |
91.0% | 89.5% | 88.3% | 86.8% | ||||
|
Absolute invasive DFS Difference |
2.8% | 2.5% | 2.5% | 3.1% |
Updated Kaplan-Meier curves for the subgroup of patients
randomized within one year after completion of adjuvant
trastuzumab therapy for (i)the intent to treat population;
(ii)the subgroup of patients with centrally confirmed HER2
positive disease; (iii)the hormone receptor positive subgroup of
patients and (iv)the hormone receptor negative subgroup of
patients are attached hereto as Exhibit 99.1 and are incorporated
herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking
statements, including statements regarding the Companys plans to
modify the SmPC in its MAA to restrict the intended population to
patients initiating neratinib treatment within one year after
completion of adjuvant trastuzumab therapy. 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,
which include, but are not limited to, the fact that the Company
has no product revenue and no products approved for marketing,
the Companys dependence on
PB272, which is still under development and may never receive
regulatory approval, the challenges associated with conducting
and enrolling clinical trials, the risk that the results of
clinical trials may not support the Companys drug candidate
claims, even if approved, the risk that physicians and patients
may not accept or use the Companys products, the Companys
reliance on third parties to conduct its clinical trials and to
formulate and manufacture its drug candidates, the Companys
dependence on licensed intellectual property, and the other risk
factors disclosed in the periodic 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 December31, 2016. 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.
| Item9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| 99.1 | Updated Kaplan-Meier Curves |
About PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI)
Puma Biotechnology, Inc. is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to over three drug candidates, including PB272 (neratinib (oral)), which the Company is developing for the treatment of patients with human epidermal growth factor receptor type 2 (HER2), positive breast cancer, and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of patients with advanced cancer, and PB357, which is an orally administered agent. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) Recent Trading Information
PUMA BIOTECHNOLOGY, INC. (NASDAQ:PBYI) closed its last trading session up +1.35 at 38.05 with 787,935 shares trading hands.