-- Similar Overall and Complete Response
Rates Observed Across Frontline AML Patients Ineligible for
Intensive Chemotherapy and in High Unmet Need Patients with
TP53-Mutant AML --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced updated
results from the magrolimab Phase 1b trial. Magrolimab is an
investigational, potential first-in-class, anti-CD47 monoclonal
antibody being studied in previously untreated acute myeloid
leukemia (AML) patients who are ineligible for intensive
chemotherapy, including patients with TP53-mutant AML. The study
continues to demonstrate high response rates with magrolimab in
combination with azacitidine, with an overall response rate of 63%
(n=27/43) among the total patient population and 69% (n=20/29) in
TP53-mutant patients. The data were presented at the 62nd American
Society of Hematology (ASH) Annual Meeting and Exposition (Abstract
#330).
“In this ongoing study, treatment with magrolimab and
azacitidine continues to achieve promising, durable responses in
patients with AML who are ineligible for first-line chemotherapy,”
said David Sallman, MD, H. Lee Moffitt Cancer Center and Research
Institute, an investigator for the clinical trial. “These findings
are especially encouraging for patients with TP53 mutations, which
are associated with poor outcomes and limited response to existing
treatment options.”
In the study, 64 patients were treated with magrolimab plus
azacitidine, including 47 patients with the TP53 mutation, a
treatment-refractory and poor-prognosis population. As of November
2020, 63% (n=27/43) of patients evaluable for efficacy achieved an
objective response per European LeukemiaNet 2017 criteria, 42%
(n=18/43) achieved a complete remission (CR), and 12% (n=5/43)
achieved a CR with an incomplete count recovery (CRi). The median
duration of response (DOR) was 9.6 months (range: 0.03+ to 18.7
months) and the median time to response was 1.95 months (range:
0.95 to 5.6 months).
For patients with the TP53 mutation, 69% (n=20/29) achieved a
response, 45% (n=13/29) achieved a CR and 14% (n=4/29) achieved a
CRi. The median DOR was 7.6 months (range: 0.03+ to 15.1+ months)
and the minimum residual disease (MRD) negativity in patients with
a CR/CRi was 29% (n=5/17).
Preliminary median overall survival (OS) for TP53-wild-type
patients (n=16) was 18.9 months (95% CI: 4.34, NE) and for
TP53-mutant patients (n=47) was 12.9 months (95% CI: 8.21, 17.28).
The median follow-up for TP53-wild-type and TP53-mutant patients
was 12.5 months and 4.7 months, respectively. Additional patients
and longer follow-up in a comparative trial are needed to further
characterize the survival benefit.
Treatment-related adverse events observed with over 15%
incidence included anemia, fatigue, blood bilirubin increased,
infusion related reaction, neutropenia, thrombocytopenia and ALT
increase. Most patients were cytopenic at baseline, and no
significant increased cytopenias, infections or immune-related
adverse events (AEs) were observed in the study. Thirty-day
all-cause mortality was 4.7% (n=3/64), and 60-day mortality was
7.8% (n=5/64). Treatment discontinuation due to drug-related AE
occurred in 4.7% of all patients.
“We continue to be encouraged by the response rates seen in this
study and are rapidly advancing the development of magrolimab based
on its potential to help address significant unmet medical needs,”
said Daejin Abidoye, Senior Vice President, Head of Oncology,
Gilead Sciences.
Magrolimab is investigational and not approved anywhere
globally. Its efficacy and safety have not been established.
About Acute Myeloid Leukemia
(AML)
AML is a type of cancer that starts in the bone marrow and can
quickly move to the blood and other parts of the body. including
the lymph nodes, spleen and central nervous system. AML most often
develops from cells that would turn into red blood cells,
neutrophils, and platelets but can also evolve from other blood
disorders such as myelodysplastic syndromes. Approximately 20,000
Americans will be diagnosed with AML each year.
About the Study
The Phase 1b trial, funded in part by the California Institute
of Regenerative Medicine (CIRM), is designed to evaluate the
safety, tolerability and efficacy of magrolimab combined with
azacitidine in untreated patients with AML who are ineligible for
induction chemotherapy. All patients in the trial received a
magrolimab 1 mg/kg priming dose, coupled with intrapatient dose
escalation, to mitigate on-target anemia. Patients were then
treated with full doses of azacitidine and a magrolimab maintenance
dose of 30 mg/kg once weekly or every two weeks. Based on
pharmacokinetics and CD47 receptor occupancy data in the bone
marrow from the ongoing trial, dosing every two weeks has been
selected to optimize patient convenience.
About Magrolimab
Magrolimab is a potential, first-in-class investigational
monoclonal antibody against CD47 and a macrophage checkpoint
inhibitor that is designed to interfere with recognition of CD47 by
the SIRPα receptor on macrophages, thus blocking the "don't eat me"
signal used by cancer cells to avoid being ingested by macrophages.
Magrolimab is being developed in several hematologic cancers,
including myelodysplastic syndrome (MDS), as well as solid tumor
malignancies.
The U.S. Food and Drug Administration (FDA) recently assigned
Breakthrough Designation to magrolimab, in combination with
azacitidine, for the treatment of adult patients with
newly-diagnosed MDS including intermediate-, high-, or very
high-risk tumor types. Magrolimab also received PRIME Designation
for treatment of MDS from the European Medicines Agency (EMA). In
addition, magrolimab received Fast Track Designation by the FDA for
the treatment of MDS, AML, diffuse large B-cell lymphoma (DLBCL)
and follicular lymphoma; and has been granted Orphan Drug
Designation by the FDA and EMA for MDS and AML.
More information about clinical trials with magrolimab is
available at www.clinicaltrials.gov (NCT03248479).
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Gilead Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the possibility of unfavorable results from ongoing and
additional clinical studies involving magrolimab, including in
combination with azacitidine, and the possibility that Gilead may
be unable to initiate and complete future studies involving
magrolimab in the anticipated timelines or at all. Further, it is
possible that Gilead may make a strategic decision to discontinue
development of magrolimab. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2020, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements
are based on information currently available to Gilead and Kite,
and Gilead and Kite assume no obligation to update any such
forward-looking statements.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20201206005027/en/
Douglas Maffei, PhD, Investors (650) 522-2739 Marian Cutler,
Media (973) 517-0519
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