LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
announced that interim results from the Phase Ib/II FB-10 clinical trial
of Puma’s investigational drug PB272 (neratinib) given in combination
with the antibody drug conjugate T-DM1 (Kadcyla, ado-trastuzumab
emtansine) were presented at the 2017 American Association for Cancer
Research Annual Meeting (AACR) that is currently taking place in
Washington, D.C. The presentation entitled, “NSABP FB-10: Phase Ib
dose-escalation study evaluating trastuzumab emtansine (T-DM1) with
neratinib in women with metastatic HER2-positive breast cancer” was
selected for an oral presentation.
The trial enrolled patients with HER2-positive metastatic breast cancer
who had previously been treated with chemotherapy and the combination of
trastuzumab (Herceptin) and pertuzumab (Perjeta). Study treatment
consisted of the standard dose of T-DM1 at 3.6 mg/kg administered
intravenously every 3 weeks and neratinib administered orally at
escalating doses of 120, 160, 200 and 240 mg per day continuously.
Primary diarrhea prophylaxis with high dose loperamide was administered.
For the 16 patients who were evaluable for efficacy, the objective
response (CR/PR) rate was 56%. More specifically, the efficacy results
from the trial demonstrated that 3 patients had a complete response (CR)
lasting 17.1 months, 11.9 months and 12+ months; 6 patients had a
partial response (PR); 3 patients had stable disease (SD); and 4
patients had progressive disease (PD). The number and types of response
per dose cohort are summarized in the table below.
|
|
|
|
Neratinib Dose
(mg/day)
|
|
|
No. of Objective Responses (CR/PR)
/ No. of Evaluable (CR/PR/SD/PD)
|
120
|
|
|
5/5 (CR 2, PR 3)
|
160
|
|
|
2/4 (CR 1, PR 1, PD 2)
|
200
|
|
|
1/5 (PR 1, SD 2, PD 2)
|
240
|
|
|
1/2 (PR 1, SD 1)
|
|
|
|
|
The waterfall plot for the trial, % Change in Size of Target Lesions,”
is shown in Figure 1, which is attached to this news release. In
addition, the slides from the presentation are available on the Puma
Biotechnology website.
The safety results of the study showed that the most frequently observed
grade 3 adverse events were diarrhea, nausea, thrombocytopenia and
hypertension. More specifically, for the 21 patients with available
safety assessments, grade 3 diarrhea was reported in 4 patients (19%),
grade 3 nausea was reported in 3 patients (14%), grade 3
thrombocytopenia was reported in 3 patients (14%), and grade 3
hypertension was reported in 2 patients (10%). There was 1 dose limiting
toxicity (DLT) at the 120 mg dose (1 of 6 patients), 3 DLTs at the 200
mg dose (3 of 8) and 2 DLTs at the 240 mg dose (2 of 3). Additional
patients are currently being accrued at the 160 mg dose in order to
define the recommended Phase II dose.
Dr. Jame Abraham, Director of the Breast Oncology Program at Taussig
Cancer Institute, Professor of Medicine at Cleveland Clinic, and
principal investigator of the study, said, “We are encouraged by these
initial findings and we will continue to enroll patients at the 160 mg
dose to further evaluate the impact in this patient population.”
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are pleased to see the high response rate of
the combination of T-DM1 and neratinib in this patient population who
were previously treated with both pertuzumab and trastuzumab in this
study. We look forward to completing enrollment in the current cohort
and moving this combination into Phase II trials.”
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 development of the Company’s drug candidates.
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 and current 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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