LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical 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.
Puma 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 Company’s
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, Puma 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 Puma’s 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%
|
|
|
|
|
|
|
Puma plans to file a Current Report on Form 8-K with the Securities and
Exchange Commission containing the 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.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the development and commercialization of innovative products to enhance
cancer care. The Company in-licenses the global development and
commercialization rights to three drug candidates—PB272 (neratinib
(oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a
potent irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1, HER2
and HER4. Currently, the Company is primarily focused on the development
of the oral version of neratinib, and its most advanced drug candidates
are directed at the treatment of HER2-positive breast cancer. The
Company believes that neratinib has clinical application in the
treatment of several other cancers as well, including non-small cell
lung cancer and other tumor types that over-express or have a mutation
in HER2.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the Company’s 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 press release
involve risks and uncertainties that could cause the Company’s 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 Company’s 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 Company’s drug candidate claims, even if approved, the risk
that physicians and patients may not accept or use the Company’s
products, the Company’s reliance on third parties to conduct its
clinical trials and to formulate and manufacture its drug candidates,
the Company’s 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 Company’s Annual Report on Form 10-K for the year ended
December 31, 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.
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