Puma Biotechnology Announces Publication of Phase II Clinical Trial of Alisertib in JAMA Oncology
March 14 2023 - 8:30AM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that the results of the Phase II TBCRC041
randomized clinical trial of alisertib alone or in combination with
fulvestrant in patients with endocrine-resistant advanced breast
cancer have been published online in JAMA Oncology. Alisertib is an
adenosine triphosphate–competitive and reversible inhibitor of
aurora kinase A and results in disruption of mitosis leading to
apoptosis of rapidly proliferating tumor cells that are dependent
on aurora kinase A.
The Phase II randomized clinical trial was conducted through the
Translational Breast Cancer Research Consortium. The trial enrolled
postmenopausal women with endocrine-resistant, HER2–negative
metastatic breast cancer who were previously treated with
fulvestrant. For the 91 evaluable patients, baseline
characteristics were well-balanced between the two arms of the
trial; however, more patients in the alisertib plus fulvestrant arm
had been previously treated with chemotherapy in the metastatic
setting (47.8% in the alisertib alone arm, 68.9% in the alisertib
plus fulvestrant arm). 100% of the patients in each arm of the
trial were previously treated with CDK 4/6 inhibitors. 37% of the
patients in the alisertib alone arm and 57.8% of patients in the
alisertib plus fulvestrant arm were previously treated with
everolimus.
The efficacy results from the trial showed that for the 46
evaluable patients in the alisertib alone arm of the trial nine
partial responses were seen, resulting in an overall response rate
of 19.6%. The median duration of response was 15.1 months, and the
24-week clinical benefit rate was 41.3%. The median
progression-free survival (PFS) was estimated to be 5.6 months. For
the 45 evaluable patients in the alisertib plus fulvestrant arm of
the trial, nine patients experienced a response, resulting in an
overall response rate of 20.0%. These responses consisted of one
patient with a complete response and 8 patients with partial
responses. The median duration of response was 8.5 months, and the
24-week clinical benefit rate was 28.9%. The estimated median PFS
was 5.4 months.
In the alisertib alone arm of the trial, the most common grade 3
or higher adverse events were neutropenia (43.4%), leukopenia
(17.4%), and anemia (19.6%). In the alisertib plus fulvestrant arm
of the trial, the most common grade 3 or higher adverse events were
neutropenia (42.2%), leukopenia (31.1%), lymphopenia (15.6%),
fatigue (11.1%), and anemia (8.9%).
“Although there have been new drugs approved for the treatment
of ER-positive HER2-negative metastatic breast cancer, there
continues to be a need for new drugs and drugs that specifically
address patients who have been previously treated with CDK 4/6
inhibitors,” said Tufia C. Haddad, MD, Associate Professor of
Oncology at the Mayo Clinic College of Medicine and co-leader of
Platform and Digital Innovation, Mayo Clinic Comprehensive Cancer
Center. “This Phase II randomized clinical trial demonstrated that
alisertib is among the first investigational targeted therapies
demonstrating promising clinical activity and a tolerable safety
profile in the setting of endocrine and CDK 4/6 inhibitor resistant
metastatic breast cancer. We look forward to the continued
development of alisertib in this patient population.”
“We are very pleased with the results from the TBCRC041 trial
demonstrating the efficacy of alisertib in patients with
ER-positive HER2-negative metastatic breast cancer. Alisertib’s
unique mechanism of action is well suited to address the mechanisms
of CDK 4/6 resistance that are targetable with an aurora kinase
inhibitor,” said Alan H. Auerbach, Chairman, Chief Executive
Officer and President of Puma. “We greatly look forward to
advancing alisertib into additional clinical trials for ER-positive
HER2-negative breast cancer.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230314005478/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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