RNS Number : 0665G
11 November 2022
11 November 2022 07:00 GMT
Imfinzi and Imjudo with chemotherapy approved in the US
for patients with metastatic non-small cell lung cancer
Approval based on POSEIDON Phase III trial results, which showed
significant survival benefit with a limited course of Imjudo added
to Imfinzi and chemotherapy
AstraZeneca's Imfinzi (durvalumab) in combination with Imjudo
(tremelimumab) plus platinum-based chemotherapy has been approved
in the US for the treatment of adult patients with Stage IV
(metastatic) non-small cell lung cancer (NSCLC).
The approval by the Food and Drug Administration (FDA) was based
on the results from the POSEIDON Phase III trial . Patients treated
with a limited course of five cycles of the anti-CTLA-4 antibody
Imjudo added to Imfinzi plus four cycles of platinum-based
chemotherapy experienced a 23% reduction in the risk of death
versus a range of chemotherapy options (based on a hazard ratio
[HR] of 0.77; 95% CI 0.65-0.92; p=0.00304). An estimated 33% of
patients were alive at two years versus 22% for chemotherapy. This
treatment combination also reduced the risk of disease progression
or death by 28% compared to chemotherapy alone (HR 0.72; 95% CI
Updated results from the POSEIDON Phase III trial after
approximately four years of follow-up presented at the European
Society of Medical Oncology (ESMO) Congress 2022 and published in
the Journal of Clinical Oncology demonstrated sustained survival
benefit, improving overall survival (OS) by 25% compared to
chemotherapy alone (HR 0.75; 95% CI 0.63-0.88). An estimated 25% of
patients treated with the combination were alive at three years
versus 13.6% for those treated with chemotherapy alone. The safety
profile for Imjudo plus Imfinzi and chemotherapy was consistent
with the known profiles of each medicine, and no new safety signals
In the US, lung cancer is the second most commonly diagnosed
cancer, with more than 236,000 patients expected to be diagnosed in
2022.(1) For patients with metastatic NSCLC, prognosis is
particularly poor, as only approximately 8% will live beyond five
years after diagnosis.(2)
Melissa Johnson, MD, Director of Lung Cancer Research, Sarah
Cannon Research Institute at Tennessee Oncology in Nashville,
Tennessee , and a lead investigator in the POSEIDON Phase III
trial, said: "Metastatic non-small cell lung cancer remains a
significant treatment challenge because many patients' tumours do
not respond well to standard therapies, including checkpoint
inhibitors. The approval of this dual immunotherapy regimen with
chemotherapy introduces a new, generally well-tolerated treatment
option for patients with this devastating disease and gives them
the chance to benefit from the long-term survival advantage seen
with CTLA-4 inhibition."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: "This approval underscores the importance
of delivering novel treatment combinations that extend survival in
metastatic non-small cell lung cancer, a complex setting where many
patients still face a dismal prognosis. This marks the second
indication for Imjudo added to Imfinzi in just a few weeks
following its approval in unresectable liver cancer, reinforcing
the benefits of this new medicine and our commitment to improving
patient outcomes in cancer settings with continued unmet need."
Regulatory applications are also currently under review in
Europe, Japan and several other countries for this indication based
on the POSEIDON results.
Imfinzi is 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.
Imfinzi is also approved in the US, the 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. Imfinzi is approved in the US and several
other countries in combination with chemotherapy for the treatment
of locally advanced or metastatic biliary tract cancer based on the
TOPAZ-1 Phase III trial, and it is approved with Imjudo in the US
for the treatment of unresectable hepatocellular carcinoma based on
the HIMALAYA Phase III trial.
Stage IV NSCLC
Lung cancer is the second most common form of cancer globally,
with more than two million patients diagnosed in 2020.(3) Lung
cancer is broadly split into NSCLC and SCLC, with 80-85% classified
as NSCLC. Within NSCLC, patients are classified as squamous,
representing 25-30% of patients, or non-squamous, in approximately
70-75% of patients.(4-6)
The POSEIDON trial was a randomised, open-label, multi-centre,
global, Phase III trial of Imfinzi plus platinum-based
chemotherapy, or Imfinzi, Imjudo and chemotherapy, versus
chemotherapy alone in the 1st-line treatment of 1,013 patients with
metastatic NSCLC. The trial population included patients with
either non-squamous or squamous disease, and the full range of
PD-L1 expression levels. POSEIDON excluded patients with certain
epidermal growth factor receptor (EGFR) mutations or anaplastic
lymphoma kinase (ALK) fusions.
In the experimental arms, patients were treated with a flat dose
of 1,500mg of Imfinzi, or Imfinzi and 75mg of Imjudo with up to
four cycles of chemotherapy every three weeks, followed by
maintenance treatment with Imfinzi once every four weeks, or
Imfinzi and a fifth dose of 75mg of Imjudo given at week 16. In
comparison, the control arm allowed up to six cycles of
chemotherapy. Pemetrexed maintenance treatment was allowed in all
arms in patients with non-squamous disease if given during the
induction phase. Nearly all patients with non-squamous disease
(95.5%) had pemetrexed and platinum, while the majority of patients
with squamous disease receiving chemotherapy (88.3%) received
gemcitabine and platinum.
Primary endpoints included progression-free survival (PFS) and
OS for the Imfinzi plus chemotherapy arm. Key secondary endpoints
included PFS and OS in the Imfinzi plus Imjudo and chemotherapy
arm. As both PFS endpoints were met for Imfinzi plus chemotherapy
and Imfinzi, Imjudo and chemotherapy, the prespecified statistical
analysis plan allowed for testing OS in the Imfinzi plus Imjudo and
chemotherapy arm. The trial was conducted in more than 150 centres
across 18 countries, including the US, Europe, South America, Asia
and South Africa.
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 its approved indications in lung cancer, Imfinzi
is also the only approved immunotherapy in unresectable or
metastatic biliary tract cancer and hepatocellular carcinoma (in
combination with Imjudo), and is also approved for previously
treated patients with advanced bladder cancer in several
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.
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.
Imjudo is also approved in combination with Imfinzi for the
treatment of unresectable hepatocellular carcinoma (HCC) and is
being tested in combination with Imfinzi across multiple tumour
types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and
bladder cancer (VOLGA and NILE).
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer
to cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit most.
The Company's comprehensive portfolio includes leading lung
cancer medicines and the next wave of innovations, including
Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab)
and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and
datopotamab deruxtecan in collaboration with Daiichi Sankyo;
Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a
pipeline of potential new medicines and combinations across diverse
mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance,
a global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
AstraZeneca in immuno-oncology (IO)
AstraZeneca 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 (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 .
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1. Lungevity. Lung Cancer Statistics. Available at: https://www.lungevity.org/for-supporters-advocates/lung-cancer-awareness/lung-cancer-statistics#1 . Accessed November 2022.
2. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed November 2022.
3. WHO. International Agency of Cancer Research. Lung Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf . Accessed November 2022.
4. Abernethy AP, et al. Real-world first-line treatment and
overall survival in non-small cell lung cancer without known EGFR
mutations or ALK rearrangements in US community oncology setting.
PLoS ONE. 2017;12(6):e0178420.
5. Cheema PK, et al. Perspectives on treatment advances for
stage III locally advanced unresectable non-small-cell lung cancer.
Curr Oncol. 2019;26(1):37-42.
6. Cancer.net. Lung Cancer - Non-Small Cell: Introduction. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction. Accessed November 2022.
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(END) Dow Jones Newswires
November 11, 2022 02:00 ET (07:00 GMT)
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