Apollomics Announces Efficacy of Vebreltinib in NSCLC Patients with MetEx14 Skipping Mutation Achieving an Overall Response Rate (ORR) of 75%
23 Octubre 2023 - 7:30AM
Apollomics Inc. (Nasdaq: APLM) (the “Company”), today announced the
presentation of vebreltinib efficacy and safety data from the
KUNPENG clinical trial at the European Society of Medical Oncology
Congress (ESMO) 2023, being held in Madrid, Spain from October
20-24, 2023.
“The clinical results demonstrate the potential of vebreltinib
as a new treatment for patients with cancers driven by MET
alterations, particularly in Non-Small Cell Lung Cancer (NSCLC)
with MetEx14 skipping mutation,” said Guo-Liang Yu, Ph.D.,
co-founder, Chairman and Chief Executive Officer of Apollomics. “We
are also pleased to see that vebreltinib is making progress in
clinical programs for patients with various MET alterations.”
In the Phase 2 KUNPENG clinical trial conducted by Apollomics’
China partner, Avistone Biotechnology Ltd. (Beijing Pearl
Biotechnology Ltd.), vebreltinib showed efficacy in patients with
locally advanced or metastatic NSCLC harboring Exon-14 skipping
mutations, with an ORR of 75%. Among other notable findings in the
KUNPENG study, ORR and disease control rate (DCR) were 100% in
patients with brain metastases (n=5) and ORR was 66.7% in patients
with liver metastases (n=6).
Preliminary efficacy and safety data from the Phase 2 KUNPENG
clinical trial (NCT04258033) is presented in poster 1378P. The
poster or abstract are available on the Apollomics website:
https://ir.apollomicsinc.com/news-events/presentations.
The data from NSCLC patients with MetEx14 skipping mutation
showed the following efficacy results:
- Of the 52 patients, 39 achieved complete or partial response,
an ORR of 75% (95% CI, 61.1-86.0), median duration of response
(DOR) of 15.9 months (95% CI, 9.2-17.8), a high disease control
rate (DCR) of 96.2% (95% CI, 86.8 to 99.5). and a notably rapid
onset of response with a median time to response of 1 month (95%
CI, 1, 2.8).
- In the 35 treatment-naïve patients, ORR was 77.1% (95% CI,
59.9-89.6), with median DOR of 16.5 months (95% CI, 9.2-NE).
- In the 17 patients who received prior systemic treatment, ORR
was 70.6% (95% CI, 44.0-89.7), with median DOR of 15.3 months (95%
CI, 3.7-17.8).
About vebreltinib (APL-101)Vebreltinib is a
potent, small molecule, orally bioavailable and highly selective
c-MET inhibitor. It works by inhibiting the aberrant activation of
the HGF/c-MET axis, a key pathway involved in tumor growth,
proliferation, and the development of resistance to certain
targeted therapies such as osimertinib. Vebreltinib is under
clinical development for treatment of solid tumors with Met
alterations by Apollomics globally and by Avistone Biotechnology in
China. Vebreltinib NDA for exon-14 skipping NSCLC is under review
by NMPA in China.
About Apollomics
Inc.Apollomics Inc. is an innovative clinical-stage
biopharmaceutical company focused on the discovery and development
of oncology therapies with the potential to be combined with other
treatment options to harness the immune system and target specific
molecular pathways to inhibit cancer. Apollomics currently has a
pipeline of nine drug candidates across multiple programs, six of
which are currently in the clinical stage of development.
Apollomics’ lead programs include vebreltinib (APL-101), a potent,
selective c-Met inhibitor for the treatment of non-small cell lung
cancer and other advanced tumors with c-Met alterations, and
uproleselan (APL-106), a specific E-Selectin antagonist that has
the potential to be used adjunctively with standard chemotherapy to
treat acute myeloid leukemia.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release includes statements that
constitute “forward-looking statements” within the meaning of the
federal securities laws, including Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of
the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). All statements, other than statements of present or
historical fact included in this press release, regarding clinical
trials and results, as well as the Company’s strategy, business
plans and objectives of management are forward-looking statements.
In addition, Apollomics cautions you that the forward-looking
statements contained in this press release are subject to unknown
risks, uncertainties and other factors, including: (i) the impact
of any current or new government regulations in the United States
and China affecting Apollomics’ operations and the continued
listing of Apollomics’ securities; (ii) the inability to achieve
successful clinical results or to obtain licensing of third-party
intellectual property rights for future discovery and development
of Apollomics’ oncology projects; (iii) the failure to
commercialize product candidates and achieve market acceptance of
such product candidates; (iv) the failure to protect Apollomics’
intellectual property; (v) breaches in data security; and other
risks included in the Annual Report on Form 20-F filed with the SEC
and other SEC filings that are available publicly on the SEC’s
website at www.sec.gov. Apollomics undertakes no obligation to
update publicly any of these forward-looking statements to reflect
actual results, new information or future events, changes in
assumptions or changes in other factors affecting forward-looking
statements, except to the extent required by applicable laws.
CONTACTS
Investor Relations Peter Vozzo ICR
Westwicke Peter.Vozzo@westwicke.com +1-443-213-0505
Media Relations Sean Leous ICR
Westwicke Sean.Leous@westwicke.com +1-646-866-4012
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