REG - AstraZeneca PLC - Imfinzi approved in EU for limited-stage SCLC

AstraZenecaAnnouncement

17/03/2025 07:15

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RNS Number : 9025A  AstraZeneca PLC  17 March 2025

 

17 March 2025

 

Imfinzi approved in the EU as first and only immunotherapy

for limited-stage small cell lung cancer

 

 Approval based on ADRIATIC Phase III trial results which

showed a 27% reduction in the risk of death versus placebo

 

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union
(EU) as monotherapy for the treatment of adults with limited-stage small cell
lung cancer (LS-SCLC) whose disease has not progressed following
platinum-based chemoradiation therapy (CRT).

 

The approval by the European Commission follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-recommended-for-eu-approval-for-ls-sclc.html)
of the Committee for Medicinal Products for Human Use and is based on results
from the ADRIATIC
(https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-is-first-and-only-immunotherapy-to-show-survival-benefit-in-limited-stage-small-cell-lung-cancer-in-global-phase-iii-trial.html)
Phase III trial, which were published in The New England Journal of Medicine
(https://www.nejm.org/) .

 

SCLC is a highly aggressive form of lung cancer, with an estimated 8,000
people treated for LS-SCLC across the five major European countries each
year.(1-2) LS-SCLC typically recurs and progresses rapidly, despite initial
response to standard-of-care chemotherapy and radiotherapy.(3-4) The prognosis
for LS-SCLC is particularly poor, as only 15-30% of patients survive for five
years after diagnosis.(5)

 

Suresh Senan, PhD, radiation oncologist at the Amsterdam University Medical
Centers, The Netherlands, and principal investigator in the trial, said: "This
approval marks a turning point for patients with limited-stage small cell lung
cancer in Europe, bringing them an immunotherapy option for the first time. An
unprecedented 57% of patients treated with durvalumab were still alive at
three years in the ADRIATIC trial. This significant advance establishes a new
benchmark in a setting where the standard of care has remained unchanged for
decades."

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business
Unit, AstraZeneca, said: "Imfinzi has the potential to transform how
limited-stage small cell lung cancer is treated as the first immunotherapy
approved in Europe in this setting. As the only immunotherapy approved for
both early and late-stage disease, Imfinzi is poised to become the foundation
for transforming outcomes for people with small cell lung cancer."

 

In the trial, results showed Imfinzi reduced the risk of death by 27% versus
placebo (based on an overall survival  OS  hazard ratio  HR  of 0.73; 95%
confidence interval  CI  0.57-0.93; p=0.0104). Estimated median OS was 55.9
months for Imfinzi versus 33.4 months for placebo. An estimated 57% of
patients treated with Imfinzi were alive at three years compared to 48% for
placebo.

 

Imfinzi also reduced the risk of disease progression or death by 24% (based on
a progression-free survival  PFS  HR of 0.76; 95% CI 0.61-0.95; p=0.0161)
versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for
placebo. An estimated 46% of patients treated with Imfinzi had not experienced
disease progression at two years compared to 34% for placebo.

 

The safety profile for Imfinzi was generally manageable and consistent with
the known profile of this medicine. No new safety signals were observed.

 

Imfinzi is approved in the US and several other countries in this setting
based on the ADRIATIC results. Regulatory applications are currently under
review in Japan and several other countries for this indication. Imfinzi is
also approved in combination with chemotherapy for the treatment of
extensive-stage SCLC based on the CASPIAN Phase III trial.

 

Notes

 

Small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women,
accounting for about one-fifth of all cancer deaths.(6-7) Lung cancer is
broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15%
of cases classified as SCLC.(8)

 

LS-SCLC (Stage I-III) accounts for approximately 30% of SCLC diagnoses and is
classified when the disease is generally only in one lung or one side of the
chest.(9) The prognosis for patients with LS-SCLC remains poor despite
curative-intent treatment with standard-of-care concurrent CRT (cCRT).(10)

 

ADRIATIC

The ADRIATIC trial is a randomised, double-blind, placebo-controlled,
multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi
plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients
with LS-SCLC who had not progressed following cCRT. In the experimental arms,
patients were randomised to receive a 1500mg fixed dose of Imfinzi with or
without Imjudo 75mg every four weeks for up to four doses/cycles each,
followed by Imfinzi every four weeks for up to 24 months.

 

The dual primary endpoints were PFS and OS for Imfinzi monotherapy versus
placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo
versus placebo, safety and quality of life measures. The trial included 164
centres in 19 countries across North and South America, Europe 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.

 

In addition to its indications in SCLC, Imfinzi is also the global standard of
care based on OS in the curative-intent setting of unresectable, Stage III
NSCLC in patients whose disease has not progressed after CRT. Additionally,
Imfinzi is approved as a perioperative treatment in combination with
neoadjuvant chemotherapy in resectable NSCLC; and in combination with a short
course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

 

Imfinzi is also approved in combination with chemotherapy (gemcitabine plus
cisplatin) in locally advanced or metastatic biliary tract cancer and in
combination with Imjudo in unresectable hepatocellular carcinoma (HCC).
Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the
EU.

 

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy
met the primary endpoint of event-free survival in the MATTERHORN Phase III
trial in resectable gastric and gastroesophageal junction cancers.

 

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is
approved as a 1(st)-line treatment for primary advanced or recurrent
endometrial cancer (mismatch repair deficient disease only in US and EU).
Imfinzi in combination with chemotherapy followed by Lynparza (olaparib)
and Imfinzi is approved for patients with mismatch repair proficient
advanced or recurrent endometrial cancer in EU and Japan.

 

Since the first approval in May 2017, more than 374,000 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, breast cancer,
several gastrointestinal and gynaecologic cancers, and other solid tumours.

 

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 and Imjudo; Enhertu (trastuzumab deruxtecan) and Datroway
(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 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 strives to redefine cancer care and help transform outcomes for
patients with Imfinzi as a monotherapy and in combination with Imjudo as well
as other novel immunotherapies and modalities. The Company is also
investigating next-generation immunotherapies like bispecific antibodies and
therapeutics that harness different aspects of immunity to target cancer,
including cell therapy and T-cell engagers.

 

AstraZeneca is 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. The Company is focused on exploring novel combination
approaches to help prevent treatment resistance and drive longer immune
responses. 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's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/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.   National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer.
Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer
(https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer)
. Accessed March 2025.

2.   AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) . Accessed March 2025.

3.   Qin A, Kalemkerian GP. Treatment Options for Relapsed Small-Cell Lung
Cancer: What Progress Have We Made? J Oncol Pract. 2018;14(6):369-370.

4.   Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage
Small-Cell Lung Cancer. N Engl J Med. 2024;391(14):1313-1327.

5.   Bebb DG, et al. Symptoms and Experiences with Small Cell Lung Cancer: A
Mixed Methods Study of Patients and Caregivers. Pulm Ther. 2023;9:435-450.

6.   World Health Organization. International Agency for Research on Cancer.
Lung Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf)
. Accessed March 2025.

7.   World Health Organization. International Agency for Research on Cancer.
World Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf)
. Accessed March 2025.

8.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer
(https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer)
. Accessed March 2025.

9.   American Cancer Society. Small Cell Lung Cancer Stages. Available at:
https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html
(https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html)
. Accessed March 2025.

10.  Senan S, et al. ADRIATIC: A phase III trial of durvalumab ±
tremelimumab after concurrent chemoradiation for patients with limited stage
small cell lung cancer. Ann Oncol. 2019;30(suppl. 2):ii25.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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