TIDMAZN
RNS Number : 1907Y
AstraZeneca PLC
05 September 2022
5 September 2022 07:00 BST
Imfinzi plus chemotherapy approved in the US as the first
immunotherapy regimen for patients with advanced biliary tract
cancer
Approval based on TOPAZ-1 Phase III trial results, which showed
Imfinzi
combination reduced risk of death by 20% vs. chemotherapy
alone
AstraZeneca's Imfinzi (durvalumab) has been approved in the US
for the treatment of adult patients with locally advanced or
metastatic biliary tract cancer (BTC) in combination with
chemotherapy (gemcitabine plus cisplatin).
The approval by the Food and Drug Administration (FDA) was based
on the results from the TOPAZ-1 Phase III trial . In an interim
analysis of TOPAZ-1, Imfinzi plus chemotherapy reduced the risk of
death by 20% versus chemotherapy alone (hazard ratio [HR] 0.80; 95%
confidence interval [CI] 0.66-0.97; p=0.021). An estimated one in
four (25%) patients treated with Imfinzi plus chemotherapy were
still alive at two years compared to one in 10 (10%) treated with
chemotherapy alone. Results were consistent across all prespecified
subgroups, regardless of PD-L1 expression or tumour location.
BTC is a group of rare and aggressive cancers that occur in the
bile ducts and gallbladder.(1,2) Approximately 23,000 people in the
US are diagnosed with BTC each year.(1) These patients have a poor
prognosis, with approximately 5% to 15% of patients with BTC
surviving five years.(3)
Aiwu Ruth He, MD, PhD, Associate Professor of Medicine, Leader
of the GI Cancer Program, Georgetown Lombardi Comprehensive Cancer
Center, Medstar Georgetown University Hospital, Washington DC, and
a lead investigator in the TOPAZ-1 Phase III trial, said: "This
approval represents a major step forward for patients with advanced
biliary tract cancer, who urgently need new, well-tolerated and
effective treatment options after more than a decade of limited
innovation. The combination of durvalumab and chemotherapy should
become a new standard of care in this setting, having demonstrated
significantly improved survival for these patients who have
historically faced a poor prognosis."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: "For the first time, patients in the US
with advanced biliary tract cancer have an immunotherapy-based
treatment option that meaningfully extends survival and is
well-tolerated. This approval for Imfinzi and chemotherapy advances
our ambition to challenge treatment expectations and transform care
for patients with gastrointestinal cancers with high unmet
need."
Stacie Lindsey, CEO, Cholangiocarcinoma Foundation, said:
"Patients have been waiting a long time for a new, first-line
treatment option for biliary tract cancer. The Foundation
congratulates AstraZeneca for engaging in rare cancer research,
which impacts patients and families nationwide. We are especially
grateful to the patients who participated in this trial making it
possible for the broader rare disease community to benefit from
this treatment."
The TOPAZ-1 Phase III trial results were presented at the 2022
American Society of Clinical Oncology Gastrointestinal Cancers
(ASCO GI) Symposium and published in the New England Journal of
Medicine Evidence . Imfinzi plus chemotherapy was generally well
tolerated and did not increase the discontinuation rate due to
adverse events compared to chemotherapy alone.
In July 2022, Imfinzi plus chemotherapy was added to the NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines(R) ) as a
Category 1 preferred regimen as 1st-line therapy for locally
advanced or metastatic BTC based on the data from TOPAZ-1.(4)
The US regulatory submission for TOPAZ-1 was reviewed under
Project Orbis, which provides a framework for concurrent submission
and review of oncology medicines among participating international
partners. As part of Project Orbis, Imfinzi plus chemotherapy is
also under regulatory review for the same indication by the
Australian Therapeutic Goods Administration, the Brazilian Health
Regulatory Agency (ANVISA), Health Canada, Israel's Ministry of
Health Pharmaceutical Administration, Singapore's Health Sciences
Authority, Switzerland's Swissmedic and the UK's Medicines and
Healthcare products Regulatory Agency.
The approval was granted after securing Priority Review and
Orphan Drug Designation for Imfinzi in the US in this setting.
Regulatory applications are also currently under review in Europe,
Japan and several other countries based on the TOPAZ-1 results.
Notes
Biliary tract cancer
BTC is a group of rare and aggressive gastrointestinal (GI)
cancers that form in the cells of the bile ducts
(cholangiocarcinoma), gallbladder or ampulla of Vater (where the
bile duct and pancreatic duct connect to the small
intestine).(1,2)
Cholangiocarcinoma is more common in China and South-East Asia
and is on the rise in Western countries.(1,3) Gallbladder cancer is
more common in certain regions of South America, India and
Japan.(5)
Early-stage BTC affecting the bile ducts and gallbladder often
presents without clear symptoms and most new cases of BTC are
therefore diagnosed at an advanced stage, when treatment options
are limited and the prognosis is poor.(3,5,6)
TOPAZ-1
TOPAZ-1 is a randomised, double-blind, placebo controlled,
multicentre, global Phase III trial of Imfinzi in combination with
chemotherapy (gemcitabine plus cisplatin) versus placebo in
combination with chemotherapy as a 1st-line treatment in 685
patients with unresectable advanced or metastatic BTC including
intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder
cancer. Patients with ampullary carcinoma were excluded.
The primary endpoint is overall survival and key secondary
endpoints included progression-free survival, objective response
rate and safety. The trial was conducted in 105 centres across 17
countries including in the US, Europe, South America and several
countries in Asia including South Korea, Thailand, Japan and
China.
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.
In addition to the approval in BTC, Imfinzi is the only approved
immunotherapy in the curative-intent setting of unresectable, Stage
III non-small cell lung cancer (NSCLC) in patients whose disease
has not progressed after chemoradiotherapy and is the global
standard of care in this setting 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 (ES-SCLC) based on the
CASPIAN Phase III trial. In 2021, updated results from the CASPIAN
trial showed Imfinzi plus chemotherapy tripled patient survival at
three years versus chemotherapy alone.
Imfinzi is also approved for previously treated patients with
advanced bladder cancer in several countries.
Since the first approval in May 2017, more than 100,000 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.
Imfinzi combinations have demonstrated clinical benefit in
multiple additional cancer settings with positive Phase III trials
in unresectable advanced liver cancer (HIMALAYA) and metastatic
NSCLC (POSEIDON).
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.(6)
Within this programme, the Company is committed to improving
outcomes in gastric, liver, BTC, oesophageal, pancreatic, and
colorectal cancers.
Imfinzi is being assessed in combinations in liver, BTC,
oesophageal and gastric cancers in an extensive development
programme spanning early to late-stage disease.
The Company aims to understand the potential of Enhertu
(trastuzumab deruxtecan), a HER2-directed antibody drug conjugate,
in the two most common GI cancers, colorectal and gastric cancers.
Enhertu is jointly developed and commercialised by AstraZeneca and
Daiichi Sankyo.
Lynparza (olaparib) is a first-in-class PARP inhibitor with a
broad and advanced clinical trial programme across multiple GI
tumour types including pancreatic and colorectal cancers. Lynparza
is developed and commercialised in collaboration with MSD (Merck
& Co., Inc. inside the US and Canada).
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate
the body's immune system to attack tumours. The Company's
Immuno-Oncology (IO) portfolio is anchored in immunotherapies that
have been designed to overcome evasion of the anti-tumour immune
response. AstraZeneca is invested in using IO approaches that
deliver long-term survival for new groups of patients across tumour
types.
The Company is pursuing a comprehensive clinical-trial programme
that includes Imfinzi as a single treatment and in combination with
tremelimumab and other novel antibodies in multiple tumour types,
stages of disease, and lines of treatment, and where relevant using
the PD-L1 biomarker as a decision-making tool to define the best
potential treatment path for a patient.
In addition, the ability to combine the IO portfolio with
radiation, chemotherapy, and targeted small molecules from across
AstraZeneca's oncology pipeline, and from research partners, may
provide new treatment options across a broad range of tumours.
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. Marcano-Bonilla L, et al. Biliary tract cancers:
epidemiology, molecular pathogenesis and genetic risk associations.
CCO. 2016;5(5).
2. ESMO. What is Biliary Tract Cancer. Available at:
https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf.
Accessed September 2022.
3. Turkes F, et al. Contemporary Tailored Oncology Treatment of
Biliary Tract Cancers. Gastroenterol Res Pract. 2019:7698786.
4. Referenced with permission from the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines(R)) for Breast Cancer
V2.2022. (c) National Comprehensive Cancer Network, Inc. 2022. All
rights reserved. Accessed September 2022. To view the most recent
and complete version of the guideline, go online to NCCN.org. NCCN
makes no warranties of any kind whatsoever regarding their content,
use or application and disclaims any responsibility for their
application or use in any way.
5. Rawla P, et al. Epidemiology of gallbladder cancer. Clin Exp Hepatol . 2019;5(2):93-102.
6. Banales JM, et al. Cholangiocarcinoma 2020: the next horizon
in mechanisms and management. Nat Rev Gastroenterol Hepatol.
2020;17:557-588.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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