Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer at the 2023 ASCO Annual Meeting
June 04 2023 - 09:00AM
Business Wire
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced the presentation of biomarker findings from a
Phase II study of alisertib plus paclitaxel versus paclitaxel alone
(Clinicatrials.gov identifier NCT02187991) in metastatic hormone
receptor positive (HR+) and triple negative (TN) breast cancer at
the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting held June 2-6 in Chicago and online. The Phase II trial was
conducted through The US Oncology Network. The results of this
trial were published by Joyce O’Shaughnessy et al. (Jama Network
Open, April 2021) and showed that the addition of alisertib to
paclitaxel improved progression-free survival (PFS) among enrolled
patients compared with paclitaxel alone (HR, 0.56; 95%CI,
0.37-0.84; P = .005).
The poster (Abstract #1037, poster #258), entitled, “Association
of C-MYC, MYC target gene, and unfolded protein response (UPR)
expression with clinical benefit from the oral aurora kinase A
(AURKA) inhibitor, alisertib (A), in combination with paclitaxel
(P) compared with P alone in patients (Pts) with HER2-negative
metastatic breast cancer (MBC),” was presented at the Breast Cancer
– Metastatic Poster Session by Sara A. Byron, Ph.D., Integrated
Cancer Genomics Division, Translational Genomics Research Institute
(TGen), part of City of Hope, on June 4 at 8:00 a.m. CDT. A copy of
the poster is available on the Puma Biotechnology website.
Archival tissue samples from patients enrolled in the clinical
study were analyzed at TGen. Of the 140 patients enrolled in the
trial, 45 from the alisertib plus paclitaxel arm and 51 from the
paclitaxel arm had sufficient tissue available for next generation
sequencing, and 31 from the alisertib plus paclitaxel arm and 35
from the paclitaxel arm had enough for RNA sequencing/gene set
enrichment analysis. The most frequently mutated genes were PIK3CA
(45%) and TP53 (44%). No mutations were significantly associated
with response or resistance to alisertib plus paclitaxel, including
those in PIK3CA, TP53, AKT1, HER2, and CDH1.
Increased MYC RNA expression was observed in tumors from
patients who did not derive clinical benefit from paclitaxel alone
(defined as PFS less than 6 months) compared to those with benefit
from paclitaxel alone (defined as PFS greater than or equal to 6
months). Increased MYC RNA expression was not observed in patients
who did not appear to benefit from alisertib plus paclitaxel.
Elevated expression of genes involved in MYC activation and in
unfolded protein response (a pro-survival mechanism) were enriched
in alisertib plus paclitaxel responders compared to paclitaxel
responders and were associated with poor response to paclitaxel
alone. In 12 patients with exceptional response to alisertib plus
paclitaxel (defined as PFS greater than or equal to 12 months),
increased expression of genes involved in MYC activation and in
epithelial to mesenchymal transition (a hallmark of cancer
progression and metastasis) was observed in comparison to cancers
from patients whose disease progressed within 6 months of
initiating alisertib + paclitaxel (n=11) or those with exceptional
response to paclitaxel alone (n=4).
“There continues to be a need for new drugs for the treatment of
metastatic ER-positive, HER2-negative breast cancer and triple
negative breast cancer,” said Joyce A. O’Shaughnessy, M.D., the
Celebrating Women Chair in Breast Cancer Research at Baylor
University Medical Center, Texas Oncology, and Chair of Breast
Cancer Research for the US Oncology Network in Dallas, Texas. “The
results of this study and the subsequent biomarker analysis
demonstrate that the addition of alisertib to paclitaxel may help
to identify which patients are likely to derive the most benefit
from alisertib and helps to identify biomarker focused populations
that can be studied in future clinical trials of alisertib.”
Sara Byron, Ph.D., Research Associate Professor in the
Integrated Cancer Genomics Division at TGen, added, “We are pleased
to have collaborated with Dr. O’ Shaughnessy on evaluating the
effect of alisertib in this breast cancer trial. The biomarkers
that were associated with clinical benefit to alisertib appeared to
be the ones associated with an aurora kinase A inhibitor like
alisertib, and we are hopeful that this work will help identify
future patient populations that may benefit from alisertib.”
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are very pleased with the results of this
biomarker analysis. We are committed to and focused on the
development of alisertib in biomarker defined populations who may
derive the greatest benefit from treatment with alisertib. This
biomarker analysis will be very helpful to the design of the future
trials of alisertib that we are planning in hormone receptor
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/20230604005006/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, +1 212 845 4200
david.schull@russopartnersllc.com
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