Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer
2023年12月11日 - 10:30PM
ビジネスワイヤ(英語)
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company (the Company), announced the design of the Phase II trial
of alisertib for the treatment of patients with HER2-negative,
hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
Based on the Company’s interactions with the U.S. Food and Drug
Administration (FDA), the Company will be initiating a Phase II
trial of alisertib in combination with endocrine treatment
(consisting of either anastrozole, exemestane, letrozole,
fulvestrant or tamoxifen) in patients with chemotherapy-naïve
HER2-negative, hormone receptor-positive metastatic breast cancer.
Patients must have been previously treated with CDK 4/6 inhibitors
and received at least two prior lines of endocrine therapy in the
recurrent or metastatic setting to be eligible for the trial. The
Company has updated the presentation on its website to include a
slide that describes the PUMA-ALI-1201 trial. The Company plans to
initiate this trial in the second half of 2024.
Patients will be dosed with alisertib given at either 30 mg, 40
mg or 50 mg twice daily (BID) on days 1-3, 8-10 and 15-17 on a
28-day cycle in combination with the endocrine therapy of the
investigator’s choice. Patients must not have been previously
treated with the endocrine treatment that will be given in
combination with alisertib in the trial. Each dose level will
enroll up to 50 patients. Patients must provide blood samples and
tissue-based biopsies so that biomarkers can be evaluated. The
primary efficacy end points will include objective response rate
(ORR), duration of response (DOR), disease control rate (DCR) and
progression-free survival (PFS). As a secondary objective, the
Company will be evaluating each of these efficacy endpoints within
biomarker subgroups in order to determine whether any biomarker
subgroup correlates with better efficacy as has been seen in
preclinical and clinical studies in other cancers including breast
cancer and small cell lung cancer. The Company will then look to
focus the future clinical development of alisertib in combination
with endocrine therapy for patients with HER2-negative hormone
receptor-positive breast cancer in patients with these
biomarkers.
Based on its interactions with the FDA, the Company believes
that this trial design will satisfy the FDA’s Project Optimus
intended to find the optimal dose of alisertib in combination with
endocrine therapy in patients with HER2-negative, hormone
receptor-positive metastatic breast cancer to move into a pivotal
Phase III trial. Once the optimal alisertib dose is identified, the
Company plans to engage with global regulatory agencies regarding
the design of a pivotal Phase III trial, which it anticipates will
be a randomized trial of alisertib plus investigator’s choice
endocrine therapy versus placebo plus investigator’s choice
endocrine therapy in patients with chemotherapy naïve
HER2-negative, hormone receptor-positive metastatic breast
cancer.
“There continues to be a need for new drugs for the treatment of
metastatic HER2-negative, hormone receptor-positive breast cancer,”
said Alvin Wong, PharmD, Chief Scientific Officer of Puma
Biotechnology. “The clinical trials of alisertib to date in
HER2-negative, hormone receptor-positive metastatic breast cancer
have demonstrated alisertib’s potential clinical benefit in this
patient population, and we look forward to initiating the
PUMA-ALI-1201 trial in 2024.”
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are excited to move forward with the
development of alisertib in HER2-negative hormone receptor-positive
metastatic breast cancer. We believe that the data from TBCRC 041,
which tested alisertib alone and with fulvestrant and the
randomized trial of alisertib plus paclitaxel versus paclitaxel
alone, have demonstrated that alisertib is active in patients with
HER2-negative hormone receptor-positive metastatic breast cancer
and in biomarker focused subgroups. We also recognize our fiscal
responsibility to the shareholders of the Company and will be
carefully managing the development expenses for alisertib in order
to protect the Company’s future profitability.”
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-licensed 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
https://www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the Company’s expectations regarding
the development of alisertib and clinical trials involving
alisertib. 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, 2022 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231211278700/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
過去 株価チャート
から 4 2024 まで 5 2024
Puma Biotechnology (NASDAQ:PBYI)
過去 株価チャート
から 5 2023 まで 5 2024