Puma Biotechnology Announces Presentation of Findings from a Phase I/Ib Study of Alisertib in Advanced EGFR-Mutated Lung Cancer
2024年6月4日 - 3:33AM
ビジネスワイヤ(英語)
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced the presentation of alisertib for the treatment
of patients with advanced osimertinib-resistant epidermal growth
factor receptor-mutated (EGFR-mutated) non-small cell lung cancer
(NCT04085315) at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting currently being held in Chicago. The poster
(Abstract #8572, Poster Bd #436), entitled, “A Phase I/Ib study of
the aurora kinase A inhibitor alisertib in combination with
osimertinib in advanced osimertinib-resistant EGFR-mutated lung
cancer,” was presented by Turja Chakrabarti, MD., University of
California, San Francisco, at the Lung Cancer – Non-Small Cell
Metastatic Poster Session, on June 3 at 1:30 p.m. CDT. A copy of
the poster is available on the Puma website.
This open-label, single-center Phase I/Ib study enrolled 21
evaluable patients with stage IV EGFR-mutated NSCLC (EGFR driver
mutation: 76.1% exon 19 deletion; 14.3% L858R; 9.5 % L861Q) who had
progressed on osimertinib monotherapy. 47.6% of patients had
previously received only first-line osimertinib monotherapy, while
52.3% had received two or greater prior lines of therapy. In the
Phase I portion of the trial, 10 patients were treated in a 3+3
dose escalation phase with alisertib using an intermittent dosing
strategy of 30 mg (n = 6) or 40 mg (n = 4) twice daily (BID) in
combination with osimertinib 80 mg daily. Alisertib was added to
osimertinib treatment at the time of disease progression on
osimertinib. Intermittent alisertib 30 mg BID was identified as the
MTD and RP2D in combination with osimertinib 80 mg daily.
In the Phase Ib expansion portion of the trial, 11 additional
patients were treated at the 30 mg alisertib BID intermittent
dosing schedule in combination with osimertinib 80 mg daily with
alisertib being added to osimertinib treatment at the time of
disease progression on osimertinib.
The most common treatment-related adverse events (AEs) (any
grade) included neutropenia (42.9%), anemia (42.9%), diarrhea
(38.1%), and lymphopenia (33.3%). Grade 3 or higher AEs neutropenia
(4.8%), anemia (4.8%), diarrhea (14.3%), and lymphopenia
(4.8%).
For the 21 evaluable patients, the investigator assessed overall
response rate was 9.5% (95% CI: 0 to 22%) and disease control rate
was 81% (95% CI: 69% to 93%). The median PFS for all patients was
5.5 months, while the median OS was 23.5 months. For patients with
TP53 mutations (n=9), the overall response rate was 0%, and the
disease control rate was 66.7%. For patients who were tp53 wild
type (n=8), the overall response rate was 25%, and the disease
control rate was 87.5%. For patients with TP53 mutations, the
progression free survival was 3.7 months, and for patients who were
tp53 wild type, the progression free survival was 8.0 months
(hazard ratio:0.42, p = 0.05).
Dr. Collin M. Blakely, the lead principal investigator of the
study and senior author of the presentation, from the University of
California in San Francisco, said, “We are pleased with the initial
results of the clinical trial and very interested in the cohort of
patients who are tp53 wild type as tp53 is known to be involved in
the aurora kinase pathway. We are modifying the protocol to limit
further enrollment in the trial to patients who are tp53 wild type
and we look forward to further studying this combination in this
biomarker directed cohort of patients.”
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, “We are pleased to see the promising efficacy
signals in the cohort of patients who are tp53 wild type. As tp53
is well known to be involved in the aurora kinase pathway, we are
pleased to see the activity of alisertib when given in combination
with osimertinib in this population of patients. We look forward to
continuing to enroll this trial in this cohort of patients.”
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)
in 2011. 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, an investigational, 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. In
February 2024, Puma initiated ALISCA-Lung 1, a Phase II clinical
trial of alisertib monotherapy for the treatment of patients with
extensive-stage small cell lung 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 Puma’s anticipated milestones and
the development of 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 U.S. Securities
and Exchange Commission from time to time, including Puma’s Annual
Report on Form 10-K for the year ended December 31, 2023 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240603691086/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, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
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過去 株価チャート
から 6 2023 まで 6 2024