ALX Oncology Announces Updated Data from Ongoing Clinical Trial (ASPEN-01) of Evorpacept Showing Emerging Clinical Benefit in Survival-Based Endpoints in Patients with Advanced Solid Tumors
November 09 2021 - 7:00AM
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a
clinical-stage immuno-oncology company developing therapies to
block the CD47 checkpoint mechanism, today announced updated
results from ASPEN-01, an ongoing evorpacept phase 1b study,
evaluating patients with solid tumor malignancies at the Society
for Immunotherapy of Cancer’s (“SITC”) 36th Anniversary Annual
Meeting [abstract 498].
ALX Oncology reports updated results from both cohorts: the
gastric/gastroesophageal junction cancer (“GC”) patient cohort
receiving evorpacept plus trastuzumab plus chemotherapy, and from
the head and neck squamous cell carcinoma (“HNSCC”) patient cohort
receiving evorpacept plus pembrolizumab with and without
chemotherapy. All data reflect response evaluable patients as of
September 1, 2021. The SITC 36th Anniversary Annual Meeting poster
is available to download under “Publications” in the Science
section of the ALX Oncology website at www.alxoncology.com.
- In patients with >2L HER2 positive GC (n=18), evorpacept in
combination with trastuzumab plus ramucirumab and paclitaxel
demonstrated an initial objective response rate (“ORR”) of 72.2%
with a median duration of response (“mDOR”) of 14.8 months, a
12-month overall survival (“OS”) rate of 79%, and a median overall
survival (“mOS”) of 17.1 months. These results compare favorably
with the clinical experience of both ramucirumab + paclitaxel and
trastuzumab-deruxtecan in similar populations.
- In patients with 1L HNSCC who have not received prior treatment
for their advanced disease (n=13), evorpacept demonstrates an
initial ORR of 38.5% with a 12-month OS rate of 87.5% and mOS not
reached in combination with pembrolizumab + 5FU + platinum. These
results compare favorably with benchmark survival data from
standard pembrolizumab + chemotherapy in the 1L HNSCC setting where
ORR is a less reliable predictor for clinical benefit compared to
longer-term metrics such as 12-month OS rate and mOS (the gold
standard of clinical benefit) in patients with aggressive
disease.
- In patients with ≥2L HNSCC who have not received a prior
checkpoint inhibitor (“CPI”) (n=10), long-term follow-up data shows
that evorpacept + pembrolizumab demonstrates a 12-month OS rate of
80% with a mOS of 24.5 months, which compares favorably with
standard pembrolizumab therapy in patients with 2L CPI naïve
HNSCC.
- Preliminary data suggest that evorpacept is well tolerated when
combined with the multi-agent chemotherapy regimens studied with no
maximum tolerated dose reached.
“These updated data provide growing support that evorpacept in
combination with the standard regimens studied may translate into a
meaningful survival benefit in patients with advanced HNSCC and GC
who historically have poor outcomes,” said Keun-Wook Lee, M.D.,
Ph.D., Professor of Seoul National University College of Medicine
and Director of Clinical Trials Center, Seoul National University
Bundang Hospital, Seoul, Korea.
“The consistency and predictive value of evorpacept’s emerging
survival-based data in aggressive solid tumor diseases is highly
encouraging,” said Sophia Randolph, M.D., Ph.D., Chief Medical
Officer, ALX Oncology. “We are excited to investigate the impact of
evorpacept on these longer-term measures of clinical benefit in our
randomized phase 2 programs in patients with HNSCC (ASPEN-03 and
ASPEN-04) and GC (ASPEN-06).”
Conference Call on November
9th at 8:00 a.m. ESTALX
Oncology will host a conference call on Tuesday, November 9, 2021
at 8:00 a.m. EST to further discuss the recent GC and HNSCC data
from ASPEN-01, the Phase 1b study of evorpacept that was presented
at the SITC 36th Anniversary Annual Meeting. In addition to ALX
Oncology’s executive management team, Dr. Kevin Harrington,
Professor of Biological Cancer Therapies and Head of the Division
of Radiotherapy and Imaging at the Institute of Cancer Research,
London, UK will be featured on the call to discuss the latest
evorpacept clinical data in HNSCC patients.
To access the conference call, please dial (844) 467-7655
(U.S./Canada) or (409) 983-9840 (international) at least 10 minutes
prior to the start time and refer to conference ID 1291278.
Presentation slides will be available to download under “News &
Events” (see “Events”) in the Investors section of the ALX Oncology
website at www.alxoncology.com.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage
immuno-oncology company focused on helping patients fight cancer by
developing therapies that block the CD47 checkpoint pathway and
bridge the innate and adaptive immune system. ALX Oncology’s lead
product candidate, evorpacept, is a next generation CD47 blocking
therapeutic that combines a high-affinity CD47 binding domain with
an inactivated, proprietary Fc domain. Evorpacept has demonstrated
promising clinical responses across a range of hematologic and
solid malignancies in combination with a number of leading
anti-cancer agents. ALX Oncology intends to continue clinical
development of evorpacept for the treatment of multiple solid tumor
indications and hematologic malignancies, including acute myeloid
leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Forward-looking
statements include statements regarding future results of
operations and financial position, business strategy, product
candidates, planned preclinical studies and clinical trials,
results of clinical trials, research and development costs,
regulatory approvals, timing and likelihood of success, plans and
objects of management for future operations, as well as statements
regarding industry trends. Such forward-looking statements are
based on ALX Oncology’s beliefs and assumptions and on information
currently available to it on the date of this press release.
Forward-looking statements may involve known and unknown risks,
uncertainties and other factors that may cause ALX Oncology’s
actual results, performance or achievements to be materially
different from those expressed or implied by the forward-looking
statements. These and other risks are described more fully in ALX
Oncology’s filings with the Securities and Exchange Commission
(“SEC”), including ALX Oncology’s Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and other documents ALX Oncology
files with the SEC from time to time. Except to the extent required
by law, ALX Oncology undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Investor Contact:
Peter Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
peter@alxoncology.com
Argot Partners
(212)-600-1902
alxoncology@argotpartners.com
Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
alx@macbiocom.com
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