Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2018 ASCO Annual Meeting

KeepHealthCare.ORG – Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2018 ASCO Annual Meeting

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 2018 American Society of Clinical
Oncology (ASCO) Annual Meeting that is currently taking place in
Chicago. The presentation entitled, “NSABP FB-10: Phase IB
Dose-Escalation Study Evaluating the Combination of Trastuzumab
Emtansine (T-DM1) with Neratinib in Women with Metastatic HER2-Positive
Breast Cancer” was selected for a poster presentation.

The FB-10 study is an open-label, single arm study with a dose
escalation phase and an expanded cohort phase to evaluate patients with
HER2-positive metastatic breast cancer who had previously been treated
with chemotherapy and the combination of trastuzumab (Herceptin) and
pertuzumab (Perjeta). The primary aim of the Phase Ib portion of the
study is to determine the safety and tolerability of the two-drug
combination. The primary aim of the Phase II portion of the study is to
demonstrate efficacy at the recommended Phase II dose of T-DM1 and
neratinib. Study treatment during the Phase Ib portion 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 to all patients. As of the date of
the presentation, the study had enrolled 27 patients. Total study
enrollment will be a maximum of 63 patients.

For the 20 patients who were evaluable for efficacy, the interim
objective response (CR/PR) rate was 60%. More specifically, the efficacy
results from the trial demonstrated that 3 patients had a complete
response (CR); 9 patients had a partial response (PR); 2 patients had
stable disease (SD); and 6 patients had progressive disease (PD). In
addition, the poster presentation is available on the Puma Biotechnology

The interim safety results of the 27 patients with available safety
assessments showed that the most frequently observed grade 3 adverse
events were diarrhea, nausea, thrombocytopenia and hypertension. More
specifically, grade 3 diarrhea was reported in 6 patients (22%), grade 3
nausea was reported in 3 patients (11%), grade 3 thrombocytopenia was
reported in 4 patients (15%), and grade 3 hypertension was reported in 3
patients (11%). 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 patients) and
2 DLTs at the 240 mg dose (2 of 3 patients). There was no DLT for the 10
patients enrolled at the 160 mg dose. The Phase II portion of the trial
is being conducted at the recommended Phase II dose of 160 mg of
neratinib per day.

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 look forward to continuing to enroll patients in
the Phase II portion of the trial to further evaluate the safety and
efficacy of the combination of T-DM1 and neratinib in this patient

Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are pleased to see the high interim objective
response rate of the combination of T-DM1 and neratinib in this study’s
patient population who were previously treated with both pertuzumab and
trastuzumab. We look forward to continued enrollment in the Phase II
portion of this trial.”


NERLYNX ® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with early-stage
HER2 overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.



Diarrhea: Aggressively manage diarrhea occurring despite
recommended prophylaxis with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients
experiencing severe and/or persistent diarrhea. Permanently
discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade
≥ 2 diarrhea that occurs after maximal dose reduction.

Hepatotoxicity: Monitor liver function tests monthly for the
first 3 months of treatment, then every 3 months while on treatment
and as clinically indicated. Withhold NERLYNX in patients experiencing
Grade 3 liver abnormalities and permanently discontinue NERLYNX in
patients experiencing Grade 4 liver abnormalities.

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were
diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis,
decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased
and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology,
Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch


Gastric acid reducing agents: Avoid concomitant use with proton pump
inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
hours after antacid dosing.

Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.

Strong or moderate CYP3A4 inducers: Avoid concomitant use.

P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
narrow therapeutic agents that are P-gp substrates when used
concomitantly with NERLYNX.


Lactation: Advise women not to breastfeed.

Please see Full
Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given
orally once daily with food, continuously for one year. Antidiarrheal
prophylaxis should be initiated with the first dose of NERLYNX and
continued during the first 2 months (56 days) of treatment and as needed

To help ensure patients have access to NERLYNX, Puma has implemented the
Puma Patient Lynx support program to assist patients and healthcare
providers with reimbursement support and referrals to resources that can
help with financial assistance. More information on the Puma Patient
Lynx program can be found at www.NERLYNX.com
or 1-855-816-5421.

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, oral was
approved by the U.S. Food and Drug Administration in July 2017 for the
extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.

Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.

Forward-Looking Statements

This news release contains forward-looking statements, including
statements regarding the enrollment in the Phase II portion of the trial
of PB272 in combination with T-DM1 in HER2-positive metastatic breast
cancer, efficacy and safety of the combination of neratinib and T-DM1,
benefits of neratinib the potential indications of our drug candidates
and the development of our drug candidates, including, but not limited
to, the anticipated timing for the commencement and completion of
various clinical trials and announcement of data relative to these
trials. All statements other than historical facts are forward–looking
statements and are based on our current expectations, forecasts and
assumptions. Forward–looking statements involve risks and uncertainties
that could cause our actual results to differ materially from the
anticipated results and expectations expressed in these forward-looking
statements. These risk and uncertainties are identified in our Annual
Report on Form 10-K for the year ended December 31, 2017, our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2018 and any
subsequent documents we file with the SEC. Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. We assume no obligation to update these
forward-looking statements except as required by law.

Source: https://www.businesswire.com/news/home/20180602005009/en/Puma-Biotechnology-Presents-Interim-Results-Phase-IbII

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