ALX Oncology Announces New Data Demonstrating Evorpacept in Combination with Zanidatamab Generates Promising Antitumor Activity in Advanced Breast Cancer
December 10 2024 - 8:00AM
ALX Oncology Holdings Inc. (“ALX Oncology” or “the Company”)
(Nasdaq: ALXO), a clinical-stage biotechnology company advancing
therapies that boost the immune system to treat cancer and extend
patients’ lives, announced results from a Phase 1b/2 clinical trial
demonstrating the company’s investigational CD47-blocker evorpacept
in combination with Jazz Pharmaceuticals’ zanidatamab generates
promising anti-tumor activity in patients with both HER2-positive
and HER2-low advanced breast cancer. The findings, which are the
first from a clinical trial evaluating the safety and efficacy of
evorpacept and zanidatamab in heavily pretreated patients with
metastatic breast cancer (mBC), will be presented on Thursday,
December 12 in a poster spotlight presentation (#PS8-09) at the
2024 San Antonio Breast Cancer Symposium (SABCS).
“These data suggest that HER2-positive patients whose cancer has
been heavily pretreated may benefit from CD47 inhibition via
evorpacept’s unique mechanism when combined with a HER2-targeted
agent,” said Alberto J. Montero, M.D., MBA, Clinical Director,
Breast Cancer Medical Oncology Program, Case Western Reserve
University, and the study’s principal investigator. “New
therapeutic options with better safety profiles are desperately
needed for these patients, and this is particularly true once
disease progresses following advanced, standard-of-care therapies
such as ENHERTU.”
The Phase 1b/2 open-label, multi-center clinical trial
(NCT05027139) evaluated the potential of evorpacept, a highly
differentiated, investigational CD47 blocker, in combination with
zanidatamab, a dual HER2-targeted bispecific antibody, as a novel
treatment for patients with previously treated inoperable, locally
advanced, or metastatic HER2-expressing breast cancer and other
cancers.
Part one of the trial evaluated the safety and recommended doses
for the combination; part two assessed the anti-tumor activity of
the resulting combination. The SABCS poster presentation will
include efficacy findings from all three of the part-two trial
cohorts: Cohort 1 (n=21) consisted of patients with HER2-positive
breast cancer who had received a median of six prior systemic
therapies in the metastatic setting. Notably, all patients in
Cohort 1 had received prior fam-trastuzumab deruxtecan-nxki
(ENHERTU®). Patients were enrolled based on local assessment of
tumor samples or central assessment. Of the 21 patients enrolled in
Cohort 1, nine were found to be HER2-positive based on central
assessment. Cohort 2 (n=15) consisted of patients with HER2-low
breast cancer who had received a median of five prior systemic
therapies. Cohort 3 (n=8) consisted of patients with other
HER2-expressing cancers.
Key trial results to be shared at SABCS 2024
include:
- HER2-positive by central assessment mBC: Patients in Cohort 1
who were HER2-positive by central assessment (n=9) showed the
greatest anti-tumor activity with a confirmed objective response
rate (cORR) of 55.6% and a median progression free survival (mPFS)
of 7.4 months.
- HER2-positive mBC: Overall, patients in Cohort 1 (n=21) had a
confirmed cORR and mPFS of 33.3% and 3.6 months, respectively.
- HER2-low mBC: Responses were also observed in Cohort 2 (cORR:
20.0%; mPFS: 1.9 months).
- As of the August 2024 data cutoff, median follow-up was 9.6
months, with six patients still on treatment. The median duration
of response was not reached for Cohort 1 patients (range: 3.6-25.9
months) and was 5.5 months for Cohort 2 patients (range: 3.6-11.0
months), with responses ongoing, including the longest observed
response, in each cohort.
Most treatment-related adverse events were grade 1 or 2. The
most frequent adverse events due to any cause were fatigue, nausea,
diarrhea, and infusion-related reactions. There were no
treatment-related deaths in the study and no non-infectious
pulmonary toxicities. These safety findings are consistent with
those observed in the >700 patients treated with evorpacept to
date.
“This study adds to the growing body of evidence suggesting that
evorpacept can treat HER2-positive cancers after patients progress
on multiple conventional HER2-directed therapies, given that the
encouraging response rate of 55 percent in this population would
not be expected,” said Jason Lettmann, Chief Executive Officer at
ALX Oncology. “The data that will be presented this week also
further validate our biomarker strategy, showing that confirmed
HER2-expression drove the largest benefit for patients.
Collectively, these findings provide us with the proof of concept
necessary to accelerate our clinical plans to advance evorpacept in
HER2-positive breast cancer.”
A copy of the poster presentation will be available on the
Publications section of ALX Oncology’s website at the start of the
presentation at SABCS on December 12, 2024.
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology
company advancing therapies that boost the immune system to treat
cancer and extend patients’ lives. ALX Oncology’s lead therapeutic
candidate, evorpacept, has demonstrated potential to serve as a
cornerstone therapy upon which the future of immuno-oncology can be
built. Evorpacept is currently being evaluated across multiple
ongoing clinical trials in a wide range of cancer indications. More
information is available at www.alxoncology.com and on LinkedIn
@ALX Oncology.
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.
Company Contact:
Caitlyn Doherty, Manager, Corporate Communications, ALX Oncology
cdoherty@alxoncology.com
(650) 466-7125
Media Contact:
Audra Friis, Sam Brown, Inc.
audrafriis@sambrown.com
(917) 519-9577
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