REG - AstraZeneca PLC - Imfinzi + Imjudo approved in US for lung cancer

AstraZenecaAnnouncement

11/11/2022 08:15

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RNS Number : 0665G  AstraZeneca PLC  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
(https://www.astrazeneca.com/media-centre/press-releases/2021/imfinzi-improves-survival-in-nsclc-in-poseidon.html)
. 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 0.60-0.86; p=0.00031).

 

Updated results
(https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-and-tremelimumab-with-chemotherapy-demonstrated-sustained-survival-benefit-in-metastatic-non-small-cell-lung-cancer.html)
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
(https://ascopubs.org/doi/abs/10.1200/JCO.22.00975?role=tab) 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 were identified.

 

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.

 

Notes

 

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)

 

POSEIDON
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
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 countries.

 

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

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 beyond treatment.

 

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
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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Lungevity. Lung Cancer Statistics. Available at:
https://www.lungevity.org/for-supporters-advocates/lung-cancer-awareness/lung-cancer-statistics#1
(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
(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.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

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