TIDMAZN
RNS Number : 8408D
AstraZeneca PLC
24 October 2022
24 October 2022 07:00 BST
Imjudo (tremelimumab) in combination with Imfinzi approved
in the US for patients with unresectable liver cancer
Approval based on HIMALAYA Phase III trial results which showed
single priming dose of Imjudo added to Imfinzi reduced risk of
death by 22% vs. sorafenib
AstraZeneca's Imjudo (tremelimumab) in combination with Imfinzi
(durvalumab) has been approved in the US for the treatment of adult
patients with unresectable hepatocellular carcinoma (HCC), the most
common type of liver cancer. The novel dose and schedule of the
combination, which includes a single dose of the anti-CTLA-4
antibody Imjudo 300mg added to the anti-PD-L1 antibody Imfinzi
1500mg followed by Imfinzi every four weeks, is called the STRIDE
regimen (Single Tremelimumab Regular Interval Durvalumab).
The approval by the US Food and Drug Administration (FDA) was
based on positive results from the HIMALAYA Phase III trial. In
this trial, patients treated with the combination of Imjudo and
Imfinzi experienced a 22% reduction in the risk of death versus
sorafenib (based on a hazard ratio [HR] of 0.78, 95% confidence
interval [CI] 0.66-0.92 p=0.0035).(1) Results were also published
in the New England Journal of Medicine Evidence showing that an
estimated 31% of patients treated with the combination were still
alive after three years, with 20% of patients treated with
sorafenib still alive at the same duration of follow-up.(2)
Liver cancer is the third-leading cause of cancer death and the
sixth most commonly diagnosed cancer worldwide.(3,4) It is the
fastest rising cause of cancer-related deaths in the US, with
approximately 36,000 new diagnoses each year.(5,6)
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial
Sloan Kettering Cancer Center (MSK), and principal investigator in
the HIMALAYA Phase III trial, said: "Patients with unresectable
liver cancer are in need of well-tolerated treatments that can
meaningfully extend overall survival. In addition to this regimen
demonstrating a favourable three-year survival rate in the HIMALAYA
trial, safety data showed no increase in severe liver toxicity or
bleeding risk for the combination, important factors for patients
with liver cancer who also have advanced liver disease."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: "With this first regulatory approval for
Imjudo, patients with unresectable liver cancer in the US now have
an approved dual immunotherapy treatment regimen that harnesses the
potential of CTLA-4 inhibition in a unique combination with a PD-L1
inhibitor to enhance the immune response against their cancer."
Andrea Wilson Woods, President & Founder, Blue Faery: The
Adrienne Wilson Liver Cancer Foundation, said: "In the past,
patients living with liver cancer had few treatment options and
faced poor prognoses. With today's approval, we are grateful and
optimistic for new, innovative, therapeutic options. These new
treatments can improve long-term survival for those living with
unresectable hepatocellular carcinoma, the most common form of
liver cancer. We appreciate the patients, their families, and the
broader liver cancer community who continue to fight for new
treatments and advocate for others."
The safety profiles of the combination of Imjudo added to
Imfinzi and for Imfinzi alone were consistent with the known
profiles of each medicine, and no new safety signals were
identified.
Regulatory applications for Imjudo in combination with Imfinzi
are currently under review in Europe, Japan and several other
countries for the treatment of patients with advanced liver cancer
based on the HIMALAYA results.
Notes
Liver cancer
About 75% of all primary liver cancers in adults are HCC.(3)
Between 80-90% of all patients with HCC also have cirrhosis.(7)
Chronic liver diseases are associated with inflammation that over
time can lead to the development of HCC.(7)
More than half of patients are diagnosed at advanced stages of
the disease, often when symptoms first appear.(8) A critical unmet
need exists for patients with HCC who face limited treatment
options.(8) The unique immune environment of liver cancer provides
clear rationale for investigating medications that harness the
power of the immune system to treat HCC.(8)
HIMALAYA
HIMALAYA was a randomised, open-label, multicentre, global Phase
III trial of Imfinzi monotherapy and a regimen comprising a single
priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by
Imfinzi every four weeks versus sorafenib, a standard-of-care
multi-kinase inhibitor.
The trial included a total of 1,324 patients with unresectable,
advanced HCC who had not been treated with prior systemic therapy
and were not eligible for locoregional therapy (treatment localised
to the liver and surrounding tissue).
The trial was conducted in 181 centres across 16 countries,
including in the US, Canada, Europe, South America and Asia. The
primary endpoint was overall survival (OS) for the combination
versus sorafenib and key secondary endpoints included OS for
Imfinzi versus sorafenib, objective response rate and
progression-free survival (PFS) for the combination and for Imfinzi
alone.
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 was recently approved to treat patients with advanced
biliary tract cancer in the US based on results from the TOPAZ-1
Phase III trial. It 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 gastrointestinal (GI) cancers, ovarian cancer,
endometrial cancer, and other solid tumours.
Imfinzi combinations have also demonstrated clinical benefit in
metastatic NSCLC in the POSEIDON Phase III trial.
Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that
targets the activity of cytotoxic T-lymphocyte-associated protein 4
(CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to
T-cell activation, priming the immune response to cancer and
fostering cancer cell death.
Beyond HIMALAYA, Imjudo is being tested in combination with
Imfinzi across multiple tumour types including locoregional HCC
(EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and
NILE).
Imjudo is also under review by global regulatory authorities in
combination with Imfinzi and chemotherapy in 1st-line metastatic
NSCLC based on the results of the POSEIDON Phase III trial, which
showed the addition of a short course of Imjudo to Imfinzi plus
chemotherapy improved both overall and progression-free survival
compared to chemotherapy alone.
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment
of GI cancers across several medicines spanning a variety of tumour
types and stages of disease. In 2020, GI cancers collectively
represented approximately 5.1 million new diagnoses leading to
approximately 3.6 million deaths.(9)
Within this programme, the Company is committed to improving
outcomes in gastric, liver, biliary tract, oesophageal, pancreatic,
and colorectal cancers.
Imfinzi (durvalumab) is being assessed in combinations in
oesophageal and gastric cancers in an extensive development
programme spanning early to late-stage disease across settings.
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 immuno-oncology (IO)
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
Imjudo (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. Imfinzi and Imjudo US prescribing information; 2022.
2. Abou-Alfa, et al. Tremelimumab plus Durvalumab in
Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022;1-12.
3. ASCO. Liver Cancer: View All Pages. Available at: https://www.cancer.net/cancer-types/liver-cancer/view-all. Accessed October 2022.
4. WHO. Liver Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Accessed October 2022.
5. Rawla, P, et al. Update in global trends and aetiology of
hepatocellular carcinoma. Contemp Oncol (Pozn). 2018; 22(3):
141-150.
6. CDC. Liver Cancer. Available at:
https://www.cdc.gov/cancer/liver/index.htm . Accessed: October
2022.
7. Tarao K, et al. Real impact of liver cirrhosis on the
development of hepatocellular carcinoma in various liver
diseases-meta -- analytic assessment. Cancer Med.
2019;8(3):1054-1065.
8. Colagrande S, et al. Challenges of advanced hepatocellular carcinoma. World J Gastroenterol. 2016;22(34):7645-7659.
9. WHO. World Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed October 2022.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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