EMERALD-1 is first global Phase III trial to
show improved clinical outcome for systemic therapy in combination
with TACE in this setting
Positive results from the EMERALD-1 Phase III trial showed
AstraZeneca’s IMFINZI® (durvalumab) in combination with TACE and
bevacizumab demonstrated a statistically significant and clinically
meaningful improvement in the primary endpoint of progression-free
survival (PFS) compared to TACE alone in patients with
hepatocellular carcinoma (HCC) eligible for embolization.
These results will be presented today at the 2024 American
Society of Clinical Oncology Gastrointestinal Cancers Symposium
(ASCO GI) in San Francisco, California (#LBA432).
Approximately 20-30% of patients with HCC, the most common type
of liver cancer, are eligible for embolization, a procedure that
blocks the blood supply to the tumor and can also deliver
chemotherapy or radiation therapy directly to the liver.1-8 Despite
being the standard of care in this setting, most patients who
receive embolization experience disease progression or recurrence
within eight months.9-11
In EMERALD-1, treatment with IMFINZI plus TACE and bevacizumab
reduced the risk of disease progression or death by 23% compared to
TACE alone (based on a hazard ratio [HR] of 0.77; 95% confidence
interval [CI] 0.61-0.98; p=0.032). Median PFS was 15 months in
patients treated with the IMFINZI combination versus 8.2 months
with TACE. The PFS benefit observed was generally consistent across
key prespecified subgroups. The secondary endpoint of time to
progression (TTP) further supports the clinical benefit of IMFINZI
plus TACE and bevacizumab in this setting, with a median TTP of 22
months versus 10 months for TACE (HR 0.63; 95% CI 0.48-0.82).
The trial will continue as planned to assess the key secondary
endpoint of overall survival (OS).
Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor
of Medicine at Clínica Universidad de Navarra, Pamplona, Spain and
a lead investigator in the EMERALD-1 trial, said: “In this earlier
liver cancer setting, embolization alone has been the standard of
care for more than 20 years, and rates of disease progression have
remained high. Adding durvalumab and bevacizumab to TACE reduced
the risk of disease progression or death by twenty-three per cent
for patients with liver cancer eligible for embolization, showing
for the first time that combining a systemic treatment with TACE
meaningfully improves this clinically relevant outcome in
earlier-stage disease.”
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: “With IMFINZI-based treatment, patients with
liver cancer eligible for embolization lived nearly seven
additional months before their disease progressed. We are
discussing these positive EMERALD-1 data with global regulatory
authorities while awaiting the final overall survival results from
the trial.”
Summary of results: EMERALD-1i
IMFINZI plus TACE and
bevacizumab
(n=204)
Placebo plus TACE
(n=205)
Median PFS (months; 95% CI)ii, iii
15.0 (11.1-18.9)
8.2 (6.9-11.1)
PFS HR (95% CI)ii, iv
0.77 (0.61-0.98)
p-valuev
0.032
PFS rate at 12 months (%)iii
55.5
39.8
PFS rate at 18 months (%)iii
43.1
28.3
Median TTP (months; 95% CI)iii, v
22.0 (16.6-24.9)
10.0 (7.1-13.6)
TTP HR (95% CI)iv, v
0.63 (0.48-0.82)
Subjects with measurable disease
IMFINZI plus TACE and
bevacizumab
(n=202)
Placebo plus TACE
(n=203)
Objective Response Rate (ORR) (%)iii
43.6
29.6
i The data cut-off date was Sept 11,
2023.
ii PFS, TTP and ORR by Blinded Independent
Central Review (BICR) per RECIST v1.1
iii Calculated using Kaplan-Meier
method
iv Calculated from stratified Cox
proportional hazards method
v The threshold of significance for this
analysis was 0.0435 based on the alpha spend at the PFS interim
analysis (2.27%) and the actual number of events at PFS final
analysis.
The safety profile for IMFINZI plus TACE and bevacizumab was
generally manageable and consistent with the known profile of each
medicine. The number of TACE procedures was consistent across arms.
No new safety signals were observed. Grade 3 and 4 adverse events
due to any cause occurred in 45.5% of patients treated with IMFINZI
plus TACE and bevacizumab and 23% of patients treated with TACE
alone.
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI® (durvalumab) or
IMJUDO® (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under
Warnings and Precautions may not include all possible severe and
fatal immune-mediated reactions. Immune-mediated adverse reactions,
which may be severe or fatal, can occur in any organ system or
tissue. Immune-mediated adverse reactions can occur at any time
after starting treatment or after discontinuation. Monitor patients
closely for symptoms and signs that may be clinical manifestations
of underlying immune-mediated adverse reactions. Evaluate clinical
chemistries including liver enzymes, creatinine,
adrenocorticotropic hormone (ACTH) level, and thyroid function at
baseline and before each dose. In cases of suspected
immune-mediated adverse reactions, initiate appropriate workup to
exclude alternative etiologies, including infection. Institute
medical management promptly, including specialty consultation as
appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO
depending on severity. See USPI Dosing and Administration for
specific details. In general, if combination of IMFINZI and IMJUDO
requires interruption or discontinuation, administer systemic
corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or
equivalent) until improvement to Grade 1 or less. Upon improvement
to Grade 1 or less, initiate corticosteroid taper and continue to
taper over at least 1 month. Consider administration of other
systemic immunosuppressants in patients whose immune-mediated
adverse reactions are not controlled with corticosteroid
therapy.
Immune-Mediated
Pneumonitis
IMFINZI in combination with IMJUDO can cause immune-mediated
pneumonitis, which may be fatal. Immune‑mediated pneumonitis
occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO,
including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
Immune-Mediated Colitis
IMFINZI in combination with IMJUDO can cause immune-mediated
colitis that is frequently associated with diarrhea.
Cytomegalovirus (CMV) infection/reactivation has been reported in
patients with corticosteroid-refractory immune-mediated colitis. In
cases of corticosteroid-refractory colitis, consider repeating
infectious workup to exclude alternative etiologies.
Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of
patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%)
adverse reactions. Intestinal perforation has been observed in
other studies of IMFINZI and IMJUDO.
Immune-Mediated
Hepatitis
IMFINZI in combination with IMJUDO can cause immune-mediated
hepatitis, which may be fatal. Immune‑mediated hepatitis occurred
in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO,
including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse
reactions.
Immune-Mediated
Endocrinopathies
- Adrenal Insufficiency: IMFINZI in combination with
IMJUDO can cause primary or secondary adrenal insufficiency. For
Grade 2 or higher adrenal insufficiency, initiate symptomatic
treatment, including hormone replacement as clinically indicated.
Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of
patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%)
adverse reactions.
- Hypophysitis: IMFINZI in combination with IMJUDO can
cause immune-mediated hypophysitis. Hypophysitis can present with
acute symptoms associated with mass effect such as headache,
photophobia, or visual field cuts. Hypophysitis can cause
hypopituitarism. Initiate symptomatic treatment including hormone
replacement as clinically indicated. Immune-mediated
hypophysitis/hypopituitarism occurred in 1% (4/388) of patients
receiving IMFINZI and IMJUDO.
- Thyroid Disorders (Thyroiditis, Hyperthyroidism, and
Hypothyroidism): IMFINZI in combination with IMJUDO can cause
immune-mediated thyroid disorders. Thyroiditis can present with or
without endocrinopathy. Hypothyroidism can follow hyperthyroidism.
Initiate hormone replacement therapy for hypothyroidism or
institute medical management of hyperthyroidism as clinically
indicated.
- Immune-mediated thyroiditis occurred in 1.5% (6/388) of
patients receiving IMFINZI and IMJUDO.
- Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of
patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%)
adverse reactions.
- Immune-mediated hypothyroidism occurred in 11% (42/388) of
patients receiving IMFINZI and IMJUDO.
- Type 1 Diabetes Mellitus, which can present with diabetic
ketoacidosis: Monitor patients for hyperglycemia or other signs
and symptoms of diabetes. Initiate treatment with insulin as
clinically indicated. Two patients 0.5% (2/388) had events of
hyperglycemia requiring insulin therapy that had not resolved at
last follow-up.
Immune-Mediated Nephritis with Renal
Dysfunction
IMFINZI in combination with IMJUDO can cause immune-mediated
nephritis. Immune-mediated nephritis occurred in 1% (4/388) of
patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%)
adverse reactions.
Immune-Mediated Dermatology
Reactions
IMFINZI in combination with IMJUDO can cause immune-mediated
rash or dermatitis. Exfoliative dermatitis, including
Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and
systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN),
has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical
emollients and/or topical corticosteroids may be adequate to treat
mild to moderate non-exfoliative rashes. Immune-mediated rash or
dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI
and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse
reactions.
Immune-Mediated
Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated
pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388)
of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%)
and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse
Reactions
The following clinically significant, immune-mediated adverse
reactions occurred at an incidence of less than 1% each in patients
who received IMFINZI in combination with IMJUDO or were reported
with the use of other immune-checkpoint inhibitors.
- Cardiac/vascular: Myocarditis, pericarditis,
vasculitis.
- Nervous system: Meningitis, encephalitis, myelitis and
demyelination, myasthenic syndrome/myasthenia gravis (including
exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune
neuropathy.
- Ocular: Uveitis, iritis, and other ocular inflammatory
toxicities can occur. Some cases can be associated with retinal
detachment. Various grades of visual impairment to include
blindness can occur. If uveitis occurs in combination with other
immune-mediated adverse reactions, consider a
Vogt-Koyanagi-Harada-like syndrome, as this may require treatment
with systemic steroids to reduce the risk of permanent vision
loss.
- Gastrointestinal: Gastritis, duodenitis.
- Musculoskeletal and connective tissue disorders:
Myositis/polymyositis, rhabdomyolysis and associated sequelae
including renal failure, arthritis, polymyalgia rheumatic.
- Endocrine: Hypoparathyroidism.
- Other (hematologic/immune): Hemolytic anemia, aplastic
anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory
response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ
transplant rejection.
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening
infusion-related reactions. Monitor for signs and symptoms of
infusion-related reactions. Interrupt, slow the rate of, or
permanently discontinue IMFINZI and IMJUDO based on the severity.
See USPI Dosing and Administration for specific details. For Grade
1 or 2 infusion-related reactions, consider using pre-medications
with subsequent doses. Infusion-related reactions occurred in 10
(2.6%) patients receiving IMFINZI and IMJUDO.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who
receive allogeneic hematopoietic stem cell transplantation (HSCT)
before or after being treated with a PD-1/L-1 blocking antibody.
Transplant-related complications include hyperacute
graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic
veno-occlusive disease (VOD) after reduced intensity conditioning,
and steroid-requiring febrile syndrome (without an identified
infectious cause). These complications may occur despite
intervening therapy between PD-1/L-1 blockade and allogeneic HSCT.
Follow patients closely for evidence of transplant-related
complications and intervene promptly. Consider the benefit versus
risks of treatment with a PD-1/L-1 blocking antibody prior to or
after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies,
IMFINZI and IMJUDO can cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential risk to a
fetus. In females of reproductive potential, verify pregnancy
status prior to initiating IMFINZI and IMJUDO and advise them to
use effective contraception during treatment with IMFINZI and
IMJUDO and for 3 months after the last dose of IMFINZI and
IMJUDO.
Lactation
There is no information regarding the presence of either IMFINZI
or IMJUDO in human milk; however, because of the potential for
serious adverse reactions in breastfed infants from IMFINZI and
IMJUDO, advise women not to breastfeed during treatment and for 3
months after the last dose.
Adverse Reactions
- In patients with unresectable HCC in the HIMALAYA study
receiving IMFINZI and IMJUDO (n=388), the most common adverse
reactions (occurring in ≥20% of patients) were rash (32%), diarrhea
(27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%),
and abdominal pain (20%).
- In patients with unresectable HCC in the HIMALAYA study
receiving IMFINZI and IMJUDO (n=388), serious adverse reactions
occurred in 41% of patients. Serious adverse reactions in >1% of
patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%),
pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury
(1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8%
of patients who received IMJUDO in combination with durvalumab,
including death (1%), hemorrhage intracranial (0.5%), cardiac
arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and
immune-mediated hepatitis (0.5%). Permanent discontinuation of
treatment regimen due to an adverse reaction occurred in 14% of
patients.
The safety and effectiveness of IMFINZI and IMJUDO have not been
established in pediatric patients.
Indication:
IMFINZI in combination with IMJUDO is indicated for the
treatment of adult patients with unresectable hepatocellular
carcinoma (uHCC).
Please see Full Prescribing Information including Medication
Guide for IMFINZI and IMJUDO.
Notes
Liver cancer
Liver cancer, of which HCC is the most common type, is the
third-leading cause of cancer death, with an estimated 900,000
people worldwide diagnosed each year and a high prevalence in
certain regions of Asia.12-14 An estimated 80-90% of all patients
with HCC also have cirrhosis.15 Chronic liver diseases such as
cirrhosis are associated with inflammation that over time can lead
to the development of HCC.15 Immunotherapy is a proven treatment
modality in HCC with approved options available for patients in
later-line settings.16
EMERALD-1
EMERALD-1 is a randomized, double-blind, placebo-controlled,
multicenter, global Phase III trial of IMFINZI plus TACE
concurrently, followed by IMFINZI with or without bevacizumab until
progression versus TACE alone in a total of 616 patients with
unresectable HCC eligible for embolization.
The trial was conducted in 157 centers across 18 countries,
including in North America, Australia, Europe, South America and
Asia. The primary endpoint was PFS for IMFINZI plus TACE and
bevacizumab versus TACE alone, and secondary endpoints include PFS
for IMFINZI plus TACE, OS, patient-reported outcomes and ORR.
IMFINZI
IMFINZI® (durvalumab) is a human monoclonal antibody that binds
to the PD-L1 protein and blocks the interaction of PD-L1 with the
PD-1 and CD80 proteins, countering the tumor's immune-evading
tactics and releasing the inhibition of immune responses.
IMFINZI is approved in combination with chemotherapy
(gemcitabine plus cisplatin) in locally advanced or metastatic
biliary tract cancer (BTC) and in combination with IMJUDO®
(tremelimumab-actl) in unresectable HCC in the US, EU, Japan, China
and many other countries based on the TOPAZ-1 and HIMALAYA Phase
III trials, respectively. Following HIMALAYA in the advanced
setting, EMERALD-1 is AstraZeneca’s second positive Phase III trial
in HCC.
In non-small cell lung cancer (NSCLC), IMFINZI is approved in
combination with a short course of IMJUDO and chemotherapy for the
treatment of metastatic NSCLC in the US, EU and Japan based on the
POSEIDON Phase III trial. IMFINZI is also the only approved
immunotherapy and the global standard of care in the
curative-intent setting of unresectable, Stage III NSCLC in
patients whose disease has not progressed after chemoradiation
therapy based on the PACIFIC Phase III trial, the results of which
have been confirmed in the real-world setting in the PACIFIC-R
study. In 2023, AstraZeneca announced positive results from the
AEGEAN Phase III trial evaluating IMFINZI in combination with
neoadjuvant chemotherapy before surgery and as adjuvant monotherapy
after surgery in resectable NSCLC.
IMFINZI is also approved in the US, EU, Japan, China and many
other countries around the world for the treatment of
extensive-stage small cell lung cancer (SCLC) based on the CASPIAN
Phase III trial. IMFINZI is approved in previously treated patients
with advanced bladder cancer in a small number of countries.
Since the first approval in May 2017, more than 200,000 patients
have been treated with IMFINZI.
As part of a broad development program, IMFINZI is being tested
as a single treatment and in combinations with other anti-cancer
treatments for patients with SCLC, NSCLC, bladder cancer, several
GI cancers, breast cancer and other solid tumors. In 2023,
AstraZeneca announced positive results for several Phase III trials
evaluating IMFINZI in various combinations, including in ovarian
(DUO-O) and endometrial (DUO-E) cancers with olaparib.
In GI cancers specifically, AstraZeneca has an extensive
clinical development program further assessing IMFINZI across
multiple settings. In addition to EMERALD-1, IMFINZI is also being
investigated in combination with bevacizumab in adjuvant HCC
(EMERALD-2), in combination with IMJUDO, lenvatinib and TACE in
embolization-eligible HCC (EMERALD-3), in resectable gastric and
gastroesophageal junction cancers (MATTERHORN) and in locally
advanced esophageal cancer (KUNLUN). In June 2023, IMFINZI added to
standard-of-care neoadjuvant chemotherapy met a key secondary
endpoint of pathologic complete response in the MATTERHORN Phase
III trial.
AstraZeneca in GI cancers
AstraZeneca has a broad development program for the treatment of
GI cancers across several medicines and a variety of tumor types
and stages of disease. In 2020, GI cancers collectively represented
approximately 5.1 million new cancer cases leading to approximately
3.6 million deaths.17
Within this program, the Company is committed to improving
outcomes in gastric, liver, biliary tract, esophageal, pancreatic
and colorectal cancers.
In addition to its indications in BTC and with IMJUDO in HCC,
IMFINZI is being assessed in combinations, including with IMJUDO,
in liver, esophageal and gastric cancers in an extensive
development program spanning early to late-stage disease across
settings.
Fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody drug
conjugate, is approved in the US and several other countries for
HER2-positive advanced gastric cancer and is being assessed in
colorectal cancer. Fam-trastuzumab deruxtecan-nxki is jointly
developed and commercialized by AstraZeneca and Daiichi Sankyo.
Olaparib, a first-in-class PARP inhibitor, is approved in the US
and several other countries for the treatment of BRCA-mutated
metastatic pancreatic cancer. Olaparib is developed and
commercialized in collaboration with Merck & Co., Inc., known
as MSD outside the US and Canada.
AstraZeneca is advancing multiple modalities that provide
complementary mechanisms for targeting Claudin 18.2, a promising
therapeutic target in gastric cancer. These include AZD0901, a
potential first-in-class antibody drug conjugate licensed from KYM
Biosciences Inc., currently in Phase II development, AZD5863, a
novel Claudin 18.2/CD3 T-cell engager bispecific antibody, licensed
from Harbour Biomed, that is in Phase I development, and AZD6422,
an armored autologous chimeric antigen receptor T-cell (CAR-T)
therapy, currently being evaluated in an Investigator Initiated
Trial (IIT) in collaboration with AbelZeta in China.
In early development, AstraZeneca is developing two Glypican 3
(GPC3) armored CAR-Ts in HCC. AZD5851, currently in Phase I
development, is being developed globally, and C-CAR031 / AZD7003 is
being co-developed with AbelZeta in China where it is under
evaluation in an IIT.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company has a comprehensive and diverse IO portfolio and
pipeline anchored in immunotherapies designed to overcome evasion
of the anti-tumor immune response and stimulate the body’s immune
system to attack tumors.
AstraZeneca aims to reimagine cancer care and help transform
outcomes for patients with IMFINZI as a single treatment and in
combination with IMJUDO as well as other novel immunotherapies and
modalities. The Company is also exploring next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer.
AstraZeneca is boldly pursuing an innovative clinical strategy
to bring IO-based therapies that deliver long-term survival to new
settings across a wide range of cancer types. With an extensive
clinical program, the Company also champions the use of IO
treatment in earlier disease stages, where there is the greatest
potential for cure.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please visit
www.astrazeneca-us.com and follow us on social media
@AstraZeneca.
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- Park JW, et al. Global patterns of hepatocellular carcinoma
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- Henriksson M, et al. Treatment patterns and survival in
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Media Inquiries Brendan McEvoy, +1 302 885 2677 Chelsea
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