TIDMAZN
RNS Number : 5524B
AstraZeneca PLC
02 June 2023
2 June 2023
Imfinzi plus chemotherapy significantly improved pathologic
complete response in gastric and gastroesophageal junction cancers
in MATTERHORN Phase III trial
First global Phase III trial of immunotherapy and
chemotherapy
combination to demonstrate clinical benefit in this setting
Trial will continue to assess event-free survival
Positive high-level results from a planned interim analysis of
the MATTERHORN Phase III trial showed treatment with AstraZeneca's
Imfinzi (durvalumab) added to standard-of-care FLOT (fluorouracil,
leucovorin, oxaliplatin, and docetaxel) neoadjuvant (before
surgery) chemotherapy demonstrated a statistically significant and
clinically meaningful improvement in the key secondary endpoint of
pathologic complete response (pCR) versus neoadjuvant chemotherapy
alone for patients with resectable, early-stage and locally
advanced (Stages II, III, IVA) gastric and gastroesophageal
junction (GEJ) cancers.
The trial will continue as planned to assess EFS and overall
survival to which the trial team, investigators and participants
remain blinded.
The safety and tolerability of adding Imfinzi to neoadjuvant
FLOT chemotherapy was consistent with the known profile of this
combination and did not decrease the number of patients able to
undergo surgery versus chemotherapy alone.
Josep Tabernero, MD, PhD, head of the Medical Oncology
Department, Vall d'Hebron University Hospital, Barcelona, Spain,
and principal investigator of the MATTERHORN trial, said: "Patients
with resectable gastric and gastroesophageal junction cancers
urgently need better treatment options, because today, one in four
patients still progress within one year even after surgery with
curative intent. These results demonstrate an increase in
pathologic complete response after adding durvalumab treatment to
FLOT chemotherapy and surgery. This is an encouraging early sign
that this regimen may deliver long-term clinical benefit for these
patients, as pathologic complete response has been correlated with
both event-free and overall survival in multiple settings. "
Susan Galbraith , Executive Vice President, Oncology R&D,
AstraZeneca , said: "These early results from MATTERHORN support
harnessing the immune system together with chemotherapy and surgery
as a new treatment approach to improve outcomes for patients with
earlier stages of gastric and gastroesophageal junction cancers.
These findings reinforce our focus on delivering novel Imfinzi
-based treatments that have the potential to redefine care for
patients with gastrointestinal cancers."
Gastric cancer is the fourth leading cause of cancer death
globally, with more than one million people diagnosed each year. By
2030, approximately 7 0 ,000 patients in the US, EU and Japan will
be newly diagnosed with Stage II-III gastric or GEJ cancers.(1) A
pproximately one in four patients with gastric cancer who undergo
surgery with curative intent develop recurrent disease within one
year, reflecting a high unmet medical need . (2)
These data will be shared with health authorities and presented
at a forthcoming medical meeting.
Notes
Gastric and gastroesophageal junction cancers
Gastric (stomach) cancer is the fifth most common cancer
worldwide and the fourth highest leading cause of cancer mortality.
(3) Approximately one million new patients were diagnosed with
gastric cancer in 2020, with 768,000 deaths reported globally.
(3)
GEJ cancer is a type of gastric cancer that arises from and
spans the area where the esophagus connects to the stomach. (4)
Disease recurrence is common in patients with resectable gastric
cancer despite undergoing curative-intent surgery and treatment
with neoadjuvant/adjuvant chemotherapy. (2) Additionally, the
five-year survival rate for gastric cancer remains poor, with only
up to a third of patients alive at five years. (5,6)
MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled,
multi-centre, global Phase III trial evaluating Imfinzi as
perioperative treatment for patients with resectable Stage II-IVA
gastric and gastroesophageal cancers. Perioperative therapy
includes treatment before and after surgery, also known as
neoadjuvant/adjuvant therapy. In the trial, 958 patients were
randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT
chemotherapy or placebo plus FLOT chemotherapy every four weeks for
two cycles prior to surgery, followed by Imfinzi or placebo every
four weeks for up to 12 cycles after surgery (including two cycles
of Imfinzi or placebo plus FLOT chemotherapy and 10 additional
cycles of Imfinzi or placebo monotherapy).
In the MATTERHORN trial, the primary endpoint is EFS, defined as
the time from randomisation until disease progression or death. Key
secondary endpoints include pCR rate, defined as the proportion of
patients who have no detectable cancer cells in resected tumour
tissue following neoadjuvant therapy, and overall survival (OS).
The trial enrolled participants in 176 centres in 20 countries,
including in the US, Canada, Europe, South America and Asia.
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 tumour'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) in unresectable hepatocellular carcinoma (HCC) in
the US, EU, Japan and several other countries based on the TOPAZ-1
and HIMALAYA Phase III trials, respectively.
In addition to its indications in gastrointestinal (GI) cancers,
Imfinzi is the only approved immunotherapy and the global standard
of care in the curative-intent setting of unresectable, Stage III
non-small cell lung cancer (NSCLC) in patients whose disease has
not progressed after chemoradiation therapy based on the PACIFIC
Phase III trial.
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. Additionally, 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 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 programme, 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, ovarian cancer, endometrial cancer and
other solid tumours.
In GI cancers specifically, AstraZeneca has several ongoing
registrational trials investigating Imfinzi across multiple liver
cancer settings (EMERALD-1, EMERALD-2 and EMERALD-3) and in locally
advanced esophageal cancer (KUNLUN).
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment
of GI cancers across several medicines and a variety of tumour
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. (7)
Within this programme, the Company is committed to improving
outcomes in gastric, liver, biliary tract, oesophageal, pancreatic
and colorectal cancers.
In addition to its indications in BTC and HCC, Imfinzi is being
assessed in combinations, including with Imjudo, in liver,
oesophageal and gastric cancers in an extensive development
programme spanning early to late-stage disease across settings.
Enhertu (trastuzumab deruxtecan), 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. Enhertu is jointly developed and commercialised
by AstraZeneca and Daiichi Sankyo.
Lynparza (olaparib), a first-in-class PARP inhibitor, is
approved the US and several other countries for the treatment of
BRCA-mutated metastatic pancreatic cancer. Lynparza is developed
and commercialised in collaboration with MSD (Merck & Co., Inc.
inside the US and Canada).
AstraZeneca also recently entered into a global exclusive
license agreement with KYM Biosciences Inc. for CMG901. CMG901 is a
potential first-in-class antibody drug conjugate targeting Claudin
18.2, a promising therapeutic target in gastric cancer, currently
in Phase I development.
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-tumour immune response and stimulate the body's immune
system to attack tumours.
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 programme, 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 catalyse 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation 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 astrazeneca.com and follow the
Company on Twitter @AstraZeneca .
Contacts
For details on how to contact the Investor Relations Team,
please click here . For Media contacts, click here .
References
1. Kantar Health, validated with SEER stage at diagnosis and Cabasag et al. and Kuzuu et al. 2021
2. Li Y, et al. Postoperative recurrence of gastric cancer
depends on whether the chemotherapy cycle was more than 9 cycles.
Medicine. 2022;101(5):e28620.
3. World Health Organisation. International Agency for Research
on Cancer. Stomach Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf
. Accessed May 2023.
4. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction .
5. American Cancer Society. Stomach Cancer Survival Rates. Available at: https://www.cancer.org/cancer/types/stomach-cancer/detection-diagnosis-staging/survival-rates.html . Accessed May 2023.
6. Cancer Research UK. Survival for stomach cancer. Available at: https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed May 2023.
7. World Health Organisation. World Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf . Accessed May 2023.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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