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2022 News Releases
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Oct. 27, 2022 - SUMMIT: EGFR Exon 18-mutant NSCLC Poster
Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022 EORTC/NCI/AACR Symposium
LOS ANGELES, Calif., Oct. 27, 2022 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a
biopharmaceutical company, presented updated findings from the Phase II SUMMIT basket trial of
neratinib for EGFR exon 18-mutant non-small cell lung cancer (NSCLC) patients at the
EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Symposium that is taking place in
Barcelona, Spain. The poster, entitled, "Neratinib efficacy in patients with EGFR exon 18-mutant
non-small cell lung cancer: findings from the SUMMIT basket trial,” was presented by Alejandro
Martínez Bueno, Head of Medical Oncology Service, Hospital Quirón Deuxes, Barcelona, Spain, on
October 27 beginning at 10:00 a.m. CEST.
The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multi-national study evaluating
the safety and efficacy of neratinib administered daily to patients who have solid tumors with
activating, EGFR exon 18 or HER2 mutations. In the EGFR exon 18-mutant cohort, patients with
lung cancer with single or complex EGFR exon 18 mutations, who were EGFR tyrosine kinase
inhibitor (TKI) naïve or were previously exposed to EGFR TKI, were enrolled into this study and
received 240 mg of neratinib monotherapy once daily. Anti-diarrheal prophylaxis with loperamide
was required for the first 2 cycles.
This cohort of 29 patients had received 1-6 prior lines of therapy in the metastatic setting
before entering the trial. Twenty-three patients (79%) had been previously treated with an
EGFR-targeted TKI (e.g., afatinib, osimertinib).
The interim efficacy results showed that the objective response rate (ORR) was 35%
overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs.
Response or stable disease lasting for ≥ 48 weeks was observed in 7 patients (6 PR, 1
SD). Final data will be presented at a later date.
The safety profile observed in the cohort of patients with EGFR exon 18-mutant NSCLC showed
that for the 31 patients who received at least one dose of neratinib, diarrhea, constipation, and
nausea were the most commonly reported adverse events. There were no reports of grade 4 diarrhea,
3 patients (10%) reported grade 3 diarrhea, and 1 patient (3%) permanently discontinued neratinib
due to diarrhea.
Dr. Martínez, an investigator of the study from Hospital Quirón Deuxes, said, “We are very excited
about these interim study results in patients with EGFR exon 18-mutant lung cancer, for whom
treatment options are limited. This study shows that neratinib has the potential to be an efficacious
and safe option to treat their disease, even following treatment with other TKIs and chemotherapy.”
Alan H. Auerbach, CEO and President of Puma Biotechnology, added, “We are very pleased to
observe that treatment with neratinib led to meaningful responses in patients with EGFR exon 18-
mutated NSCLC. Improving the lives of our cancer patients is our foremost goal, and we are
pleased to see the benefit that was provided to these patients in the SUMMIT trial.”
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. Puma in-licenses the global
development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib,
intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in
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. In February 2020, NERLYNX was
also approved by the FDA in combination with capecitabine for the treatment of adult patients with
advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-
HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by
the European Commission in 2018 for the extended adjuvant treatment of adult patients with early
stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than
one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
In September 2022, Puma entered into an exclusive license agreement for the development and
commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered
inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the
treatment of small cell lung cancer and breast cancer.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
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 https://www.NERLYNX.com or 1-855-816-5421.
INDICATIONS:
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:
- As a single agent, for the extended adjuvant treatment of adult patients with early stage
HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult patients with advanced or
metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2
based regimens in the metastatic setting.
IMPORTANT SAFETY INFORMATION Regarding NERLYNX® (neratinib) U.S.
Indication:
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide
prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat 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 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 contraception.
ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash,
stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract
infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased
appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia,
urinary tract infection, upper respiratory tract infection, abdominal distention, renal
impairment, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-
844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 www.fda.gov/medwatch.
DRUG INTERACTIONS:
- Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate
NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate
NERLYNX by at least 3 hours with antacids.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal
concentration change may lead to serious adverse reactions when used concomitantly with
NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.
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Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the
development of Puma’s product candidates. All forward-looking statements involve risks and
uncertainties that could cause Puma’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 risk factors disclosed in the periodic and current reports filed by Puma with the Securities and
Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the
year ended December 31, 2021, and subsequent reports. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date hereof. Puma
assumes no obligation to update these forward-looking statements, except as required by law.
Contact:
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, Russo Partners, +1-212-845-4271
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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